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Generic ArmonAir Digihaler Availability

Last updated on Nov 7, 2023.

ArmonAir Digihaler is a brand name of fluticasone, approved by the FDA in the following formulation(s):

ARMONAIR DIGIHALER (fluticasone propionate - powder;inhalation)

  • Manufacturer: TEVA PHARM
    Approval date: February 20, 2020
    Strength(s): 0.055MG/INH [RLD], 0.113MG/INH [RLD], 0.232MG/INH [RLD]
  • Manufacturer: TEVA PHARM
    Approval date: April 8, 2022
    Strength(s): 0.03MG/INH (discontinued) [RLD]

Has a generic version of ArmonAir Digihaler been approved?

No. There is currently no therapeutically equivalent version of ArmonAir Digihaler available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of ArmonAir Digihaler. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Dose counters for inhalers, inhalers and methods of assembly thereof
    Patent 10,022,510
    Issued: July 17, 2018
    Inventor(s): Walsh Declan & Fenlon Derek & Kaar Simon & Hazenberg Jan Geert & Buck Daniel & Clancy Paul & Uschold Robert Charles & Karg Jeffrey A.

    A tape system for a dose counter for an inhaler, the tape system having a main elongate tape structure, dosing indicia located on the main elongate tape structure, tape positioning indicia located on the main elongate tape structure, a tape size marker located on the main elongate tape structure indicating a number of dosing indicia on the tape, and priming indicia located on the main elongate tape structure, the priming indicia being located between the dosing indicia and one end of the tape.

    Patent expiration dates:

    • May 18, 2031
      ✓ 
      Drug product
  • Dose counters for inhalers, inhalers and methods of assembly thereof
    Patent 10022510*PE
    Issued: July 17, 2018
    Inventor(s): Walsh Declan & Fenlon Derek & Kaar Simon & Hazenberg Jan Geert & Buck Daniel & Clancy Paul & Uschold Robert Charles & Karg Jeffrey A.

    A tape system for a dose counter for an inhaler, the tape system having a main elongate tape structure, dosing indicia located on the main elongate tape structure, tape positioning indicia located on the main elongate tape structure, a tape size marker located on the main elongate tape structure indicating a number of dosing indicia on the tape, and priming indicia located on the main elongate tape structure, the priming indicia being located between the dosing indicia and one end of the tape.

    Patent expiration dates:

    • November 18, 2031
  • Dose counter for inhaler having an anti-reverse rotation actuator
    Patent 10,124,131
    Issued: November 13, 2018
    Inventor(s): Walsh Declan & Fenlon Derek & Kaar Simon & Hazenberg Jan Geert & Buck Dan & Clancy Paul & Uschold Robert Charles & Karg Jeffrey A.

    An incremental dose counter for a metered dose inhaler having a body arranged to retain a canister for movement of the canister relative thereto, the incremental dose counter having a main body, an actuator arranged to be driven and to drive an incremental output member in a count direction in response to canister motion, the actuator being configured to restrict motion of the output member in a direction opposite to the count direction.

    Patent expiration dates:

    • May 18, 2031
      ✓ 
      Drug product
  • Dose counter for inhaler having an anti-reverse rotation actuator
    Patent 10124131*PE
    Issued: November 13, 2018
    Inventor(s): Walsh Declan & Fenlon Derek & Kaar Simon & Hazenberg Jan Geert & Buck Dan & Clancy Paul & Uschold Robert Charles & Karg Jeffrey A.

    An incremental dose counter for a metered dose inhaler having a body arranged to retain a canister for movement of the canister relative thereto, the incremental dose counter having a main body, an actuator arranged to be driven and to drive an incremental output member in a count direction in response to canister motion, the actuator being configured to restrict motion of the output member in a direction opposite to the count direction.

    Patent expiration dates:

    • November 18, 2031
  • Airflow adaptor for a breath-actuated dry powder inhaler
    Patent 10,195,375
    Issued: February 5, 2019
    Inventor(s): Blair Julian Alexander & Buck Daniel & Hazenberg Jan Geert & Zeng Xian-Ming
    Assignee(s): NORTON HEALTHCARE LIMITED

    An airflow adaptor for a breath-actuated dry powder inhaler. The airflow adaptor includes a conduit having a proximal end and a distal end, wherein the proximal end allows fluid communication from a deagglomerator outlet port to the distal end of the conduit, and wherein the airflow adaptor further includes provisions for allowing air to flow from a proximal end of the adaptor to a distal end of the adaptor independently of the airflow in the conduit when a breath induced low pressure is applied to the distal end of the airflow adaptor.

    Patent expiration dates:

    • February 14, 2031
      ✓ 
      Drug product
  • Airflow adaptor for a breath-actuated dry powder inhaler
    Patent 10195375*PE
    Issued: February 5, 2019
    Inventor(s): Blair Julian Alexander & Buck Daniel & Hazenberg Jan Geert & Zeng Xian-Ming
    Assignee(s): NORTON HEALTHCARE LIMITED

    An airflow adaptor for a breath-actuated dry powder inhaler. The airflow adaptor includes a conduit having a proximal end and a distal end, wherein the proximal end allows fluid communication from a deagglomerator outlet port to the distal end of the conduit, and wherein the airflow adaptor further includes provisions for allowing air to flow from a proximal end of the adaptor to a distal end of the adaptor independently of the airflow in the conduit when a breath induced low pressure is applied to the distal end of the airflow adaptor.

    Patent expiration dates:

    • August 14, 2031
  • Dose counter for inhaler having an anti-reverse rotation actuator
    Patent 10,561,808
    Issued: February 18, 2020
    Inventor(s): Walsh Declan & Fenlon Derek & Kaar Simon & Hazenberg Jan Geert & Buck Daniel & Clancy Paul & Uschold Robert Charles & Karg Jeffrey A.

    A dose counter for an inhaler includes a counter display arranged to indicate dosage information, and a drive system arranged to move the counter display incrementally in a first direction from a first station to a second station in response to actuation input. A regulator is provided which is arranged to act upon the counter display at the first station to regulate motion of the counter display at the first station to incremental movements.

    Patent expiration dates:

    • January 1, 2032
      ✓ 
      Drug product
  • Dose counter for inhaler having an anti-reverse rotation actuator
    Patent 10561808*PE
    Issued: February 18, 2020
    Inventor(s): Walsh Declan & Fenlon Derek & Kaar Simon & Hazenberg Jan Geert & Buck Daniel & Clancy Paul & Uschold Robert Charles & Karg Jeffrey A.

    A dose counter for an inhaler includes a counter display arranged to indicate dosage information, and a drive system arranged to move the counter display incrementally in a first direction from a first station to a second station in response to actuation input. A regulator is provided which is arranged to act upon the counter display at the first station to regulate motion of the counter display at the first station to incremental movements.

    Patent expiration dates:

    • July 1, 2032
  • Compliance monitoring module for a breath-actuated inhaler
    Patent 10,569,034
    Issued: February 25, 2020
    Inventor(s): Morrison Mark Steven & Weitzel Douglas E. & Calderon Oliveras Enrique & Buck Daniel
    Assignee(s): Norton (Waterford) Limited

    A compliance monitoring module for a breath-actuated inhaler comprising: a miniature pressure sensor, a sensor port of said sensor being pneumatically coupled to a flow channel through which a user can inhale; a processor configured to: receive a signal originating from a dosing mechanism of the inhaler indicating that medication has been released; receive data from a sensing element of the sensor; and based on said signal from said dosing mechanism and said data from said sensing element, make a determination that inhalation of a breath containing medication through said flow channel complies with one or more predetermined requirements for successful dosing; and a transmitter configured to, responsive to said determination, issue a dosing report.

    Patent expiration dates:

    • August 16, 2036
      ✓ 
      Drug product
  • Compliance monitoring module for a breath-actuated inhaler
    Patent 10569034*PE
    Issued: February 25, 2020
    Inventor(s): Morrison Mark Steven & Weitzel Douglas E. & Calderon Oliveras Enrique & Buck Daniel
    Assignee(s): Norton (Waterford) Limited

    A compliance monitoring module for a breath-actuated inhaler comprising: a miniature pressure sensor, a sensor port of said sensor being pneumatically coupled to a flow channel through which a user can inhale; a processor configured to: receive a signal originating from a dosing mechanism of the inhaler indicating that medication has been released; receive data from a sensing element of the sensor; and based on said signal from said dosing mechanism and said data from said sensing element, make a determination that inhalation of a breath containing medication through said flow channel complies with one or more predetermined requirements for successful dosing; and a transmitter configured to, responsive to said determination, issue a dosing report.

    Patent expiration dates:

    • February 16, 2037
  • Dry powder inhalation apparatus
    Patent 10,765,820
    Issued: September 8, 2020
    Inventor(s): Barney Brian & "OLeary David" & Striebig Rachel
    Assignee(s): NORTON HEALTHCARE LTD.

    A dry powder inhalation apparatus includes a housing, a reservoir for medicament located within the housing, a mouthpiece disposed on the housing for insertion in the mouth of a user for inhalation of a predetermined dose of medicament, a delivery channel between a discharge outlet of the reservoir and the mouthpiece for delivering the predetermined dose of medicament, a device positioned within the housing and normally held adjacent the reservoir for receiving the predetermined dose of medicament from the discharge outlet and transferring it to the delivery channel, and a release mechanism adapted to release the device and permit controlled movement thereof to the delivery channel for the delivery, the release mechanism being located at least partially outside of the housing for manual operation by the user.

    Patent expiration dates:

    • May 19, 2025
      ✓ 
      Drug product
  • Dry powder inhalation apparatus
    Patent 10765820*PE
    Issued: September 8, 2020
    Inventor(s): Barney Brian & "OLeary David" & Striebig Rachel
    Assignee(s): NORTON HEALTHCARE LTD.

    A dry powder inhalation apparatus includes a housing, a reservoir for medicament located within the housing, a mouthpiece disposed on the housing for insertion in the mouth of a user for inhalation of a predetermined dose of medicament, a delivery channel between a discharge outlet of the reservoir and the mouthpiece for delivering the predetermined dose of medicament, a device positioned within the housing and normally held adjacent the reservoir for receiving the predetermined dose of medicament from the discharge outlet and transferring it to the delivery channel, and a release mechanism adapted to release the device and permit controlled movement thereof to the delivery channel for the delivery, the release mechanism being located at least partially outside of the housing for manual operation by the user.

    Patent expiration dates:

    • November 19, 2025
  • Patent 10,918,816
    Issued: November 30, -0001

    Patent expiration dates:

    • December 14, 2035
      ✓ 
      Drug product
  • Patent 10918816*PE
    Issued: November 30, -0001

    Patent expiration dates:

    • June 14, 2036
  • Inhaler
    Patent 11,000,653
    Issued: May 11, 2021
    Inventor(s): Calderon Oliveras Enrique & Buck Daniel & Kantor Erica Jamie & Weir Ross William & Roche James & Gardner Steven David & Kivlin Robert Owen
    Assignee(s): Norton (Waterford) Limited

    The introduction of electronics into a drug delivery device may introduce certain technical challenges, such as durability, electro-mechanical integration, and drug delivery performance. The present disclosure provides solutions for inclusion of an electronics module with an inhaler. For example, heat stakes may be used to secure a printed circuit board (PCB) to an electronics module's housing. Also for example, a slider may be used to transfer vertical movement of an inhaler's yoke to an electronics module's switch. Also for example, certain seals may be used when interfacing the electronics module to other portions of the device's housing to achieve a desired performance.

    Patent expiration dates:

    • December 18, 2038
      ✓ 
      Drug product
  • Inhaler
    Patent 11000653*PE
    Issued: May 11, 2021
    Inventor(s): Calderon Oliveras Enrique & Buck Daniel & Kantor Erica Jamie & Weir Ross William & Roche James & Gardner Steven David & Kivlin Robert Owen
    Assignee(s): Norton (Waterford) Limited

    The introduction of electronics into a drug delivery device may introduce certain technical challenges, such as durability, electro-mechanical integration, and drug delivery performance. The present disclosure provides solutions for inclusion of an electronics module with an inhaler. For example, heat stakes may be used to secure a printed circuit board (PCB) to an electronics module's housing. Also for example, a slider may be used to transfer vertical movement of an inhaler's yoke to an electronics module's switch. Also for example, certain seals may be used when interfacing the electronics module to other portions of the device's housing to achieve a desired performance.

    Patent expiration dates:

    • June 18, 2039
  • Drug delivery device with electronics and power management
    Patent 11,173,259
    Issued: November 16, 2021
    Inventor(s): Calderon Oliveras Enrique & Kesten Amir
    Assignee(s): Norton (Waterford) Limited

    A system may limit the number of times an inhalation device transmits inhalation data to a single time to reduce the battery usage of the inhalation device. The system may include an inhalation device that has medicament and an electronics module. The system may limit the number of times the inhalation device transmits new inhalation data to any mobile device to a single time by causing the server to receive the new inhalation data from one of the mobile devices and causing the server to transmit the new inhalation data to other of the mobile devices prior to the other mobile devices transmitting a request for the new inhalation data to the inhalation device. The inhalation device may include a Quick Response (QR) code, and a mobile application may determine at least one of a medication type or a number of doses of the inhalation device from the QR code.

    Patent expiration dates:

    • July 6, 2040
      ✓ 
      Drug product
  • Drug delivery device with electronics and power management
    Patent 11173259*PE
    Issued: November 16, 2021
    Inventor(s): Calderon Oliveras Enrique & Kesten Amir
    Assignee(s): Norton (Waterford) Limited

    A system may limit the number of times an inhalation device transmits inhalation data to a single time to reduce the battery usage of the inhalation device. The system may include an inhalation device that has medicament and an electronics module. The system may limit the number of times the inhalation device transmits new inhalation data to any mobile device to a single time by causing the server to receive the new inhalation data from one of the mobile devices and causing the server to transmit the new inhalation data to other of the mobile devices prior to the other mobile devices transmitting a request for the new inhalation data to the inhalation device. The inhalation device may include a Quick Response (QR) code, and a mobile application may determine at least one of a medication type or a number of doses of the inhalation device from the QR code.

    Patent expiration dates:

    • January 6, 2041
  • Inhalation device with integrated electronics
    Patent 11,266,796
    Issued: March 8, 2022
    Inventor(s): Yang Dong & Moorhouse Dylan A.
    Assignee(s): Norton (Waterford) Limited

    A device () for delivering medication to a user includes a circular or elliptical body () that includes a mouthpiece (), a flexible strip () of medication, a lever (), and a mouthpiece cover (), where the mouthpiece cover is rotatable about the body. An electronics module () includes a communication circuit (), a power supply (), a sensor system (), and a switch. The lever is configured to actuate the switch when the lever is moved from a closed position to an open position. The lever is further configured to advance a dose of medication on the flexible strip when moved from the closed position to the open position. The switch switches the electronics module from an off state to an active state when the lever is actuated for a first time by a user. The electronics module is configured to not return to the off state thereafter.

    Patent expiration dates:

    • February 22, 2041
      ✓ 
      Drug product
  • Inhalation device with integrated electronics
    Patent 11266796*PE
    Issued: March 8, 2022
    Inventor(s): Yang Dong & Moorhouse Dylan A.
    Assignee(s): Norton (Waterford) Limited

    A device () for delivering medication to a user includes a circular or elliptical body () that includes a mouthpiece (), a flexible strip () of medication, a lever (), and a mouthpiece cover (), where the mouthpiece cover is rotatable about the body. An electronics module () includes a communication circuit (), a power supply (), a sensor system (), and a switch. The lever is configured to actuate the switch when the lever is moved from a closed position to an open position. The lever is further configured to advance a dose of medication on the flexible strip when moved from the closed position to the open position. The switch switches the electronics module from an off state to an active state when the lever is actuated for a first time by a user. The electronics module is configured to not return to the off state thereafter.

    Patent expiration dates:

    • August 22, 2041
  • Patent 11,344,685
    Issued: November 30, -0001

    Patent expiration dates:

    • September 26, 2039
      ✓ 
      Drug product
  • Patent 11344685*PE
    Issued: November 30, -0001

    Patent expiration dates:

    • March 26, 2040
  • Patent 11,351,317
    Issued: November 30, -0001

    Patent expiration dates:

    • February 10, 2038
      ✓ 
      Drug product
  • Patent 11351317*PE
    Issued: November 30, -0001

    Patent expiration dates:

    • August 10, 2038
  • Drug delivery device with electronics
    Patent 11,357,935
    Issued: June 14, 2022
    Inventor(s): Calderon Oliveras Enrique & Lewis Carl L. & "Cotton Symon DOyly" & Gardner Steven D. & Kivlin Robert O. & Zur Amir
    Assignee(s): Norton (Waterford) Limited

    A system may include a mobile application residing on an external device and an inhalation device. The inhalation device may include a mouthpiece, a mouthpiece cover, medicament, and an electronics module comprising a processor. The inhalation device may be configured to both prepare a dose of medicament for delivery to a user and cause the processor to transition between power states when the mouthpiece cover is moved from a closed position to an open position to expose the mouthpiece. The electronics module or the mobile application may be configured to generate usage events based on usage of the inhalation device by the user. The electronics module may also include a pressure sensor, and the electronics module or the mobile application may be configured to determine whether a usage event is a good inhalation event, a fair inhalation event, or a no inhalation event based on feedback from the pressure sensor.

    Patent expiration dates:

    • September 24, 2038
      ✓ 
      Drug product
  • Drug delivery device with electronics
    Patent 11357935*PE
    Issued: June 14, 2022
    Inventor(s): Calderon Oliveras Enrique & Lewis Carl L. & "Cotton Symon DOyly" & Gardner Steven D. & Kivlin Robert O. & Zur Amir
    Assignee(s): Norton (Waterford) Limited

    A system may include a mobile application residing on an external device and an inhalation device. The inhalation device may include a mouthpiece, a mouthpiece cover, medicament, and an electronics module comprising a processor. The inhalation device may be configured to both prepare a dose of medicament for delivery to a user and cause the processor to transition between power states when the mouthpiece cover is moved from a closed position to an open position to expose the mouthpiece. The electronics module or the mobile application may be configured to generate usage events based on usage of the inhalation device by the user. The electronics module may also include a pressure sensor, and the electronics module or the mobile application may be configured to determine whether a usage event is a good inhalation event, a fair inhalation event, or a no inhalation event based on feedback from the pressure sensor.

    Patent expiration dates:

    • March 24, 2039
  • Drug delivery device with electronics
    Patent 11,439,777
    Issued: September 13, 2022
    Inventor(s): Calderon Oliveras Enrique & Lewis Carl L. & "Cotton Symon DOyly" & Gardner Steven D. & Kivlin Robert O.
    Assignee(s): Norton (Waterford) Limited

    A device for delivering medication to a user may include a main body, an electronics module, and a slider. The main body may include a mouthpiece, a medication reservoir, and a mouthpiece cover, where the mouthpiece cover may be hinged to the main body. The electronics module may include a communication circuit, a pressure sensor, and a switch. The slider may be configured to engage the switch when the mouthpiece cover moves from a closed position to an open position. The switch may be configured to switch the electronics module from an off state or a sleep state to an active state. The electronics module may be configured to never return to the off state after the mouthpiece cover is moved to expose the mouthpiece for the first time by the user.

    Patent expiration dates:

    • May 24, 2040
      ✓ 
      Drug product
  • Drug delivery device with electronics
    Patent 11439777*PE
    Issued: September 13, 2022
    Inventor(s): Calderon Oliveras Enrique & Lewis Carl L. & "Cotton Symon DOyly" & Gardner Steven D. & Kivlin Robert O.
    Assignee(s): Norton (Waterford) Limited

    A device for delivering medication to a user may include a main body, an electronics module, and a slider. The main body may include a mouthpiece, a medication reservoir, and a mouthpiece cover, where the mouthpiece cover may be hinged to the main body. The electronics module may include a communication circuit, a pressure sensor, and a switch. The slider may be configured to engage the switch when the mouthpiece cover moves from a closed position to an open position. The switch may be configured to switch the electronics module from an off state or a sleep state to an active state. The electronics module may be configured to never return to the off state after the mouthpiece cover is moved to expose the mouthpiece for the first time by the user.

    Patent expiration dates:

    • November 24, 2040
  • Patent 11,464,923
    Issued: November 30, -0001

    Patent expiration dates:

    • June 19, 2040
      ✓ 
      Drug product
  • Patent 11464923*PE
    Issued: November 30, -0001

    Patent expiration dates:

    • December 19, 2040
  • Patent 7,540,282
    Issued: November 30, -0001

    Patent expiration dates:

    • May 6, 2023
      ✓ 
      Drug product
  • Patent 7540282*PED
    Issued: November 30, -0001

    Patent expiration dates:

    • November 6, 2023
      ✓ 
      Pediatric exclusivity
  • Dry powder inhalation apparatus
    Patent 8,651,103
    Issued: February 18, 2014
    Inventor(s): Barney Brian & "OLeary David" & Striebig Rachel
    Assignee(s): Norton Healthcare Ltd.

    The invention relates to dry powder inhalation apparatus usually operable by breath of a user which provides for controlled and smooth transfer of medicament during multiple actuations by a user. A mechanism of the apparatus for achieving this controlled and smooth transfer includes a device () normally held adjacent a reservoir for receiving medicament in a cup or receptacle () and which is generally movable transversely of a longitudinal axis of the apparatus to delivery channels of the apparatus. This bodily shifting of the device () is achieved by a yoke acting on an abutment () thereof. Spillage of medicament in the apparatus is avoided.

    Patent expiration dates:

    • March 26, 2028
      ✓ 
      Drug product
  • Dry powder inhalation apparatus
    Patent 8651103*PED
    Issued: February 18, 2014
    Inventor(s): Barney Brian & "OLeary David" & Striebig Rachel
    Assignee(s): Norton Healthcare Ltd.

    The invention relates to dry powder inhalation apparatus usually operable by breath of a user which provides for controlled and smooth transfer of medicament during multiple actuations by a user. A mechanism of the apparatus for achieving this controlled and smooth transfer includes a device () normally held adjacent a reservoir for receiving medicament in a cup or receptacle () and which is generally movable transversely of a longitudinal axis of the apparatus to delivery channels of the apparatus. This bodily shifting of the device () is achieved by a yoke acting on an abutment () thereof. Spillage of medicament in the apparatus is avoided.

    Patent expiration dates:

    • September 26, 2028
      ✓ 
      Pediatric exclusivity
  • Airflow adaptor for a breath-actuated dry powder inhaler
    Patent 8,714,149
    Issued: May 6, 2014
    Inventor(s): Blair Julian Alexander & Buck Daniel & Hazenberg Jan Geert & Zeng Xian-Ming
    Assignee(s): Norton Healthcare Limited

    An airflow adaptor for a breath-actuated dry powder inhaler. The airflow adaptor includes a conduit having a proximal end and a distal end, wherein the proximal end allows fluid communication from a deagglomerator outlet port to the distal end of the conduit, and wherein the airflow adaptor further includes provisions for allowing air to flow from a proximal end of the adaptor to a distal end of the adaptor independently of the airflow in the conduit when a breath induced low pressure is applied to the distal end of the airflow adaptor.

    Patent expiration dates:

    • November 8, 2030
      ✓ 
      Drug product
    • February 25, 2032
      ✓ 
      Drug product
  • Airflow adaptor for a breath-actuated dry powder inhaler
    Patent 8714149*PED
    Issued: May 6, 2014
    Inventor(s): Blair Julian Alexander & Buck Daniel & Hazenberg Jan Geert & Zeng Xian-Ming
    Assignee(s): Norton Healthcare Limited

    An airflow adaptor for a breath-actuated dry powder inhaler. The airflow adaptor includes a conduit having a proximal end and a distal end, wherein the proximal end allows fluid communication from a deagglomerator outlet port to the distal end of the conduit, and wherein the airflow adaptor further includes provisions for allowing air to flow from a proximal end of the adaptor to a distal end of the adaptor independently of the airflow in the conduit when a breath induced low pressure is applied to the distal end of the airflow adaptor.

    Patent expiration dates:

    • May 8, 2031
      ✓ 
      Pediatric exclusivity
    • August 25, 2032
      ✓ 
      Pediatric exclusivity
  • Dose counters for inhalers, inhalers and methods of assembly thereof
    Patent 8,978,966
    Issued: March 17, 2015
    Inventor(s): Walsh Declan & Fenlon Derek & Kaar Simon & Hazenberg Jan Geert & Buck Dan & Clancy Paul & Uschold Robert Charles & Karg Jeffrey A.

    A manually operated metered dose inhaler includes a dose counter chamber including a dose display tape driven by a ratchet wheel which is driven in turn by an actuator pawl actuated by movement of a canister, the tape unwinding from a stock bobbin during use of the inhaler, a rotation regulator being provided for the stock bobbin and including a wavelike engagement surface with concavities which engage against control elements in the form of protrusions on resilient forks of a split pin thereby permitting incremental unwinding of the stock bobbin yet resisting excessive rotation if the inhaler is dropped onto a hard surface.

    Patent expiration dates:

    • January 13, 2032
      ✓ 
      Drug product
  • Dose counters for inhalers, inhalers and methods of assembly thereof
    Patent 8978966*PED
    Issued: March 17, 2015
    Inventor(s): Walsh Declan & Fenlon Derek & Kaar Simon & Hazenberg Jan Geert & Buck Dan & Clancy Paul & Uschold Robert Charles & Karg Jeffrey A.

    A manually operated metered dose inhaler includes a dose counter chamber including a dose display tape driven by a ratchet wheel which is driven in turn by an actuator pawl actuated by movement of a canister, the tape unwinding from a stock bobbin during use of the inhaler, a rotation regulator being provided for the stock bobbin and including a wavelike engagement surface with concavities which engage against control elements in the form of protrusions on resilient forks of a split pin thereby permitting incremental unwinding of the stock bobbin yet resisting excessive rotation if the inhaler is dropped onto a hard surface.

    Patent expiration dates:

    • July 13, 2032
      ✓ 
      Pediatric exclusivity
  • Dose counters for inhalers, inhalers and methods of assembly thereof
    Patent 9,216,260
    Issued: December 22, 2015
    Inventor(s): Walsh Declan & Fenlon Derek & Kaar Simon & Hazenberg Jan Geert & Buck Dan & Clancy Paul & Uschold Robert Charles & Karg Jeffrey A.

    A manually operated metered dose inhaler includes a dose counter chamber including a dose display tape driven by a ratchet wheel which is driven in turn by an actuator pawl actuated by movement of a canister, the tape unwinding from a stock bobbin during use of the inhaler, a rotation regulator being provided for the stock bobbin and including a wavelike engagement surface with concavities which engage against control elements in the form of protrusions on resilient forks of a split pin thereby permitting incremental unwinding of the stock bobbin yet resisting excessive rotation if the inhaler is dropped onto a hard surface.

    Patent expiration dates:

    • June 28, 2031
      ✓ 
      Drug product
  • Dose counters for inhalers, inhalers and methods of assembly thereof
    Patent 9216260*PED
    Issued: December 22, 2015
    Inventor(s): Walsh Declan & Fenlon Derek & Kaar Simon & Hazenberg Jan Geert & Buck Dan & Clancy Paul & Uschold Robert Charles & Karg Jeffrey A.

    A manually operated metered dose inhaler includes a dose counter chamber including a dose display tape driven by a ratchet wheel which is driven in turn by an actuator pawl actuated by movement of a canister, the tape unwinding from a stock bobbin during use of the inhaler, a rotation regulator being provided for the stock bobbin and including a wavelike engagement surface with concavities which engage against control elements in the form of protrusions on resilient forks of a split pin thereby permitting incremental unwinding of the stock bobbin yet resisting excessive rotation if the inhaler is dropped onto a hard surface.

    Patent expiration dates:

    • December 28, 2031
      ✓ 
      Pediatric exclusivity
  • Dry powder inhalation apparatus
    Patent 9,463,288
    Issued: October 11, 2016
    Inventor(s): Barney Brian & "OLeary David" & Striebig Rachel
    Assignee(s): NORTON HEALTHCARE LTD.

    A dry powder inhalation apparatus operable by breath of a user which provides for controlled and smooth transfer of medicament during multiple actuations by a user. A mechanism of the apparatus for achieving this controlled and smooth transfer includes a device normally held adjacent a reservoir for receiving medicament in a cup or receptacle and which is generally movable transversely of a longitudinal axis of the apparatus to delivery channels of the apparatus. This bodily shifting of the device is achieved by a yoke acting on an abutment thereof. Spillage of medicament in the apparatus is avoided.

    Patent expiration dates:

    • May 19, 2025
      ✓ 
      Drug product
  • Dry powder inhalation apparatus
    Patent 9463288*PED
    Issued: October 11, 2016
    Inventor(s): Barney Brian & "OLeary David" & Striebig Rachel
    Assignee(s): NORTON HEALTHCARE LTD.

    A dry powder inhalation apparatus operable by breath of a user which provides for controlled and smooth transfer of medicament during multiple actuations by a user. A mechanism of the apparatus for achieving this controlled and smooth transfer includes a device normally held adjacent a reservoir for receiving medicament in a cup or receptacle and which is generally movable transversely of a longitudinal axis of the apparatus to delivery channels of the apparatus. This bodily shifting of the device is achieved by a yoke acting on an abutment thereof. Spillage of medicament in the apparatus is avoided.

    Patent expiration dates:

    • November 19, 2025
      ✓ 
      Pediatric exclusivity
  • Process for preparing a medicament
    Patent 9,616,024
    Issued: April 11, 2017
    Inventor(s): Zeng Xian-Ming & Tee Seah Kee
    Assignee(s): Norton Healthcare Ltd.

    The present invention provides a process for preparing a particulate medicament that has greater homogeneity and a lower adhesion between the particles of the active ingredient and the carrier. The process comprises the steps of: (a) combining a pharmaceutically active ingredient in the form of an agglomerate of primary particles having an agglomerate particle size such that the agglomerate is capable of passing through a sieve having a mesh of 50-3000 .mu.m with a pharmaceutically acceptable particulate carrier, and (b) mixing the resultant material in a mixer to break up the agglomerate into primary particles dispersed in the pharmaceutically acceptable particulate carrier such that 90% or more of the pharmaceutically active ingredient exists as primary particles having a particle size of 50 .mu.m or less.

    Patent expiration dates:

    • September 1, 2024
      ✓ 
      Drug product
  • Process for preparing a medicament
    Patent 9616024*PED
    Issued: April 11, 2017
    Inventor(s): Zeng Xian-Ming & Tee Seah Kee
    Assignee(s): Norton Healthcare Ltd.

    The present invention provides a process for preparing a particulate medicament that has greater homogeneity and a lower adhesion between the particles of the active ingredient and the carrier. The process comprises the steps of: (a) combining a pharmaceutically active ingredient in the form of an agglomerate of primary particles having an agglomerate particle size such that the agglomerate is capable of passing through a sieve having a mesh of 50-3000 .mu.m with a pharmaceutically acceptable particulate carrier, and (b) mixing the resultant material in a mixer to break up the agglomerate into primary particles dispersed in the pharmaceutically acceptable particulate carrier such that 90% or more of the pharmaceutically active ingredient exists as primary particles having a particle size of 50 .mu.m or less.

    Patent expiration dates:

    • March 1, 2025
      ✓ 
      Pediatric exclusivity
  • Dose counter for inhaler having a bore and shaft arrangement
    Patent 9,731,087
    Issued: August 15, 2017
    Inventor(s): Walsh Declan & Fenlon Derek & Kaar Simon & Hazenberg Jan Geert & Buck Daniel & Clancy Paul & Uschold Robert Charles & Karg Jeffrey A.

    A dose counter for an inhaler, the dose counter having a display tape arranged to be incrementally driven from a tape stock bobbin onto an incremental tape take-up drive shaft, the bobbin having an internal bore supported by and for rotation about a support shaft, at least one of the bore and support shaft having a protrusion which is resiliently biased into frictional engagement with the other of the bore and support shaft with longitudinally extending mutual frictional interaction.

    Patent expiration dates:

    • May 18, 2031
      ✓ 
      Drug product
  • Dose counter for inhaler having a bore and shaft arrangement
    Patent 9731087*PED
    Issued: August 15, 2017
    Inventor(s): Walsh Declan & Fenlon Derek & Kaar Simon & Hazenberg Jan Geert & Buck Daniel & Clancy Paul & Uschold Robert Charles & Karg Jeffrey A.

    A dose counter for an inhaler, the dose counter having a display tape arranged to be incrementally driven from a tape stock bobbin onto an incremental tape take-up drive shaft, the bobbin having an internal bore supported by and for rotation about a support shaft, at least one of the bore and support shaft having a protrusion which is resiliently biased into frictional engagement with the other of the bore and support shaft with longitudinally extending mutual frictional interaction.

    Patent expiration dates:

    • November 18, 2031
      ✓ 
      Pediatric exclusivity
  • Compliance monitoring module for a breath-actuated inhaler
    Patent 9,782,550
    Issued: October 10, 2017
    Inventor(s): Morrison Mark Steven & Weitzel Douglas E. & Calderon Oliveras Enrique & Buck Daniel

    A compliance monitoring module for a breath-actuated inhaler comprising: a miniature pressure sensor, a sensor port of said sensor being pneumatically coupled to a flow channel through which a user can inhale; a processor configured to: receive a signal originating from a dosing mechanism of the inhaler indicating that medication has been released; receive data from a sensing element of the sensor; and based on said signal from said dosing mechanism and said data from said sensing element, make a determination that inhalation of a breath containing medication through said flow channel complies with one or more predetermined requirements for successful dosing; and a transmitter configured to, responsive to said determination, issue a dosing report.

    Patent expiration dates:

    • August 28, 2035
      ✓ 
      Drug product
  • Compliance monitoring module for a breath-actuated inhaler
    Patent 9782550*PED
    Issued: October 10, 2017
    Inventor(s): Morrison Mark Steven & Weitzel Douglas E. & Calderon Oliveras Enrique & Buck Daniel

    A compliance monitoring module for a breath-actuated inhaler comprising: a miniature pressure sensor, a sensor port of said sensor being pneumatically coupled to a flow channel through which a user can inhale; a processor configured to: receive a signal originating from a dosing mechanism of the inhaler indicating that medication has been released; receive data from a sensing element of the sensor; and based on said signal from said dosing mechanism and said data from said sensing element, make a determination that inhalation of a breath containing medication through said flow channel complies with one or more predetermined requirements for successful dosing; and a transmitter configured to, responsive to said determination, issue a dosing report.

    Patent expiration dates:

    • February 28, 2036
      ✓ 
      Pediatric exclusivity
  • Compliance monitoring module for a breath-actuated inhaler
    Patent 9,782,551
    Issued: October 10, 2017
    Inventor(s): Morrison Mark Steven & Weitzel Douglas E. & Calderon Oliveras Enrique & Buck Daniel

    A compliance monitoring module for a breath-actuated inhaler comprising: a miniature pressure sensor, a sensor port of said sensor being pneumatically coupled to a flow channel through which a user can inhale; a processor configured to: receive a signal originating from a dosing mechanism of the inhaler indicating that medication has been released; receive data from a sensing element of the sensor; and based on said signal from said dosing mechanism and said data from said sensing element, make a determination that inhalation of a breath containing medication through said flow channel complies with one or more predetermined requirements for successful dosing; and a transmitter configured to, responsive to said determination, issue a dosing report.

    Patent expiration dates:

    • August 28, 2035
      ✓ 
      Drug product
  • Compliance monitoring module for a breath-actuated inhaler
    Patent 9782551*PED
    Issued: October 10, 2017
    Inventor(s): Morrison Mark Steven & Weitzel Douglas E. & Calderon Oliveras Enrique & Buck Daniel

    A compliance monitoring module for a breath-actuated inhaler comprising: a miniature pressure sensor, a sensor port of said sensor being pneumatically coupled to a flow channel through which a user can inhale; a processor configured to: receive a signal originating from a dosing mechanism of the inhaler indicating that medication has been released; receive data from a sensing element of the sensor; and based on said signal from said dosing mechanism and said data from said sensing element, make a determination that inhalation of a breath containing medication through said flow channel complies with one or more predetermined requirements for successful dosing; and a transmitter configured to, responsive to said determination, issue a dosing report.

    Patent expiration dates:

    • February 28, 2036
      ✓ 
      Pediatric exclusivity

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • July 9, 2024 - NEW PATIENT POPULATION
    • January 9, 2025 - PEDIATRIC EXCLUSIVITY

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.