Generic ProAir Digihaler Availability
Last updated on Apr 10, 2025.
See also: Generic ProAir HFA, Generic ProAir RespiClick
ProAir Digihaler is a brand name of albuterol, approved by the FDA in the following formulation(s):
PROAIR DIGIHALER (albuterol sulfate - powder, metered;inhalation)
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Manufacturer: TEVA BRANDED PHARM
Approval date: December 21, 2018
Strength(s): EQ 0.09MG BASE/INH (discontinued) [RLD]
All of the above formulations have been discontinued.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of ProAir 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.
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Dose counters for inhalers, inhalers and methods of assembly thereof
Patent 10,022,510
Issued: July 17, 2018
Inventor(s): Walsh; Declan et al.
Assignee(s): Ivax Pharmaeuticals Ireland (Waterford, IE); Norton (Waterford) Limited (Waterford, IE); Teva Pharmaceuticals Ireland (Waterford, IE)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✓
- May 18, 2031
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Dose counter for inhaler having an anti-reverse rotation actuator
Patent 10,124,131
Issued: November 13, 2018
Inventor(s): Walsh; Declan et al.
Assignee(s): Ivax Pharmaceuticals Ireland (Waterford, IE); Norton (Waterford) Limited (Waterford, IE); Teva Pharmaceuticals Ireland (Waterford, IE)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✓
- May 18, 2031
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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) LimitedA 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✓
- August 16, 2036
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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✓
- May 19, 2025
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Compliance monitoring module for a breath-actuated inhaler
Patent 10,918,816
Issued: February 16, 2021
Inventor(s): Morrison; Mark Steven et al.
Assignee(s): Norton (Waterford) Limited (Waterford, IE)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:
- December 14, 2035✓
- December 14, 2035
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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) LimitedThe 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✓
- December 18, 2038
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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) LimitedA 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✓
- July 6, 2040
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Inhalation device with integrated electronics
Patent 11,266,796
Issued: March 8, 2022
Inventor(s): Yang Dong & Moorhouse Dylan A.
Assignee(s): Norton (Waterford) LimitedA 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✓
- February 22, 2041
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Drug delivery device with electronics
Patent 11,344,685
Issued: May 31, 2022
Inventor(s): Calderon Oliveras; Enrique et al.
Assignee(s): Norton (Waterford) Limited (Waterford, IE)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:
- September 26, 2039✓
- September 26, 2039
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Drug delivery device with electronics
Patent 11,351,317
Issued: June 7, 2022
Inventor(s): Calderon Oliveras; Enrique et al.
Assignee(s): Norton (Waterford) Limited (Waterford, IE)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:
- February 10, 2038✓
- February 10, 2038
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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) LimitedA 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✓
- September 24, 2038
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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) LimitedA 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✓
- May 24, 2040
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Inhaler system
Patent 11,464,923
Issued: October 11, 2022
Inventor(s): Liu; Xinyu et al.
Assignee(s): Norton (Waterford) Limited (Waterford, IE)Provided is a system including a plurality of inhalers that each include a processor configured to determine a value of a usage parameter relating to use of the respective first inhaler, encrypt data based on the value, and transmit the encrypted data. At least two of the inhalers include different medicament, such as a rescue medicament and a maintenance medicament. The system includes an external device that includes a processor configured to distinguish between the encrypted data of each respective inhaler, determine respective usage information relating to each of the distinct types of medicament based on the respective encrypted data, and control a user interface (e.g., of the external device) to communicate the usage information related to each inhaler and/or each respective type of medicament.
Patent expiration dates:
- June 19, 2040✓
- June 19, 2040
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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✓
- March 26, 2028
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Dose counters for inhalers, inhalers and methods of assembly thereof
Patent 8,978,966
Issued: March 17, 2015
Inventor(s): Walsh; Declan et al.
Assignee(s): Teva Pharmaceuticals Ireland (Utrecht, NL); Norton Waterford (Utrecht, NL); IVAX Pharmaceuticals Ireland (Utrecht, NL)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✓
- January 13, 2032
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Dose counters for inhalers, inhalers and methods of assembly thereof
Patent 9,216,260
Issued: December 22, 2015
Inventor(s): Walsh; Declan et al.
Assignee(s): IVAX Pharmaceuticals Ireland (Utrecht, NL); Norton Waterford (Utrecht, NL); Teva Pharmaceuticals Ireland (Utrecht, NL)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✓
- June 28, 2031
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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✓
- May 19, 2025
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Dose counter for inhaler having a bore and shaft arrangement
Patent 9,731,087
Issued: August 15, 2017
Inventor(s): Walsh; Declan et al.
Assignee(s): IVAX PHARMACEUTICALS IRELAND (N/A, IE); TEVA PHARMACEUTICALS IRELAND (N/A, IE); NORTON (WATERFORD) LIMITED (N/A, IE)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✓
- May 18, 2031
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Compliance monitoring module for a breath-actuated inhaler
Patent 9,782,550
Issued: October 10, 2017
Inventor(s): Morrison; Mark Steven et al.
Assignee(s): MicroDose Therapeutx, Inc. (Ewing, NJ); Norton (Waterford) Limited (Waterford, IE)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✓
- August 28, 2035
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Compliance monitoring module for a breath-actuated inhaler
Patent 9,782,551
Issued: October 10, 2017
Inventor(s): Morrison; Mark Steven et al.
Assignee(s): MicroDose Therapeutx, Inc. (Ewing, NJ); Norton (Waterford) Limited (Waterford, IE)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✓
- August 28, 2035
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Glossary
Term | Definition |
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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. |
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