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Generic AirDuo Digihaler Availability

Last updated on Sep 8, 2022.

See also: Generic AirDuo Respiclick

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

AIRDUO DIGIHALER (fluticasone propionate; salmeterol xinafoate - powder;inhalation)

  • Manufacturer: TEVA PHARM
    Approval date: July 12, 2019
    Strength(s): 0.055MG/INH;EQ 0.014MG BASE/INH [RLD], 0.113MG/INH;EQ 0.014MG BASE/INH [RLD], 0.232MG/INH;EQ 0.014MG BASE/INH [RLD]

Has a generic version of AirDuo Digihaler been approved?

An Authorized Generic version of AirDuo Digihaler has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.

List of authorized generic versions:

  • Fluticasone Propionate and Salmeterol RESPIRATORY (INHALATION) POWDER, METERED 55; 14 ug/1; ug
    Teva Pharmaceuticals USA, Inc.
    NDC Code: 000933607
  • Fluticasone Propionate and Salmeterol RESPIRATORY (INHALATION) POWDER, METERED 113; 14 ug/1; ug
    Teva Pharmaceuticals USA, Inc.
    NDC Code: 000933608
  • Fluticasone Propionate and Salmeterol RESPIRATORY (INHALATION) POWDER, METERED 232; 14 ug/1; ug
    Teva Pharmaceuticals USA, Inc.
    NDC Code: 000933609
  • Fluticasone Propionate and Salmeterol RESPIRATORY (INHALATION) POWDER, METERED 113; 14 ug/1; ug
    A-S Medication Solutions
    NDC Code: 500903271
  • Fluticasone Propionate and Salmeterol RESPIRATORY (INHALATION) POWDER, METERED 55; 14 ug/1; ug
    A-S Medication Solutions
    NDC Code: 500903272
  • Fluticasone Propionate and Salmeterol RESPIRATORY (INHALATION) POWDER, METERED 232; 14 ug/1; ug
    A-S Medication Solutions
    NDC Code: 500903387
  • Fluticasone Propionate and Salmeterol RESPIRATORY (INHALATION) POWDER, METERED 113; 14 ug/1; ug
    Bryant Ranch Prepack
    NDC Code: 636298809
  • Fluticasone Propionate and Salmeterol RESPIRATORY (INHALATION) POWDER, METERED 232; 14 ug/1; ug
    Bryant Ranch Prepack
    NDC Code: 636298810
  • Fluticasone Propionate and Salmeterol RESPIRATORY (INHALATION) POWDER, METERED 55; 14 ug/1; ug
    Bryant Ranch Prepack
    NDC Code: 636298811

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of AirDuo 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
    Assignee(s): Ivax Pharmaeuticals Ireland Norton (Waterford) Limited Teva Pharmaceuticals Ireland

    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
  • Patent 10022510*

    Patent expiration dates:

    • November 18, 2031
  • Dose counter for inhaler having an anti-reverse rotation actuator
    Patent 10,124,131
    Issued: November 13, 2018
    Assignee(s): Ivax Pharmaceuticals Ireland Norton (Waterford) Limited Teva Pharmaceuticals Ireland

    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
  • Patent 10124131*

    Patent expiration dates:

    • November 18, 2031
  • Airflow adaptor for a breath-actuated dry powder inhaler
    Patent 10,195,375
    Issued: February 5, 2019
    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
  • Patent 10195375*

    Patent expiration dates:

    • August 14, 2031
  • Patent 10,561,808

    Patent expiration dates:

    • January 1, 2032
      ✓ 
      Drug product
  • Patent 10561808*

    Patent expiration dates:

    • July 1, 2032
  • Patent 10,569,034

    Patent expiration dates:

    • August 16, 2036
      ✓ 
      Drug product
  • Patent 10569034*

    Patent expiration dates:

    • February 16, 2037
  • Patent 10,765,820

    Patent expiration dates:

    • May 19, 2025
      ✓ 
      Drug product
  • Patent 10765820*

    Patent expiration dates:

    • November 19, 2025
  • Patent 10,918,816

    Patent expiration dates:

    • December 14, 2035
      ✓ 
      Drug product
  • Patent 10918816*

    Patent expiration dates:

    • June 14, 2036
  • Patent 11,000,653

    Patent expiration dates:

    • December 18, 2038
      ✓ 
      Drug product
  • Patent 11000653*

    Patent expiration dates:

    • June 18, 2039
  • Patent 11,173,259

    Patent expiration dates:

    • July 6, 2040
      ✓ 
      Drug product
  • Patent 11173259*

    Patent expiration dates:

    • January 6, 2041
  • Patent 11,266,796

    Patent expiration dates:

    • February 22, 2041
      ✓ 
      Drug product
  • Patent 11266796*

    Patent expiration dates:

    • August 22, 2041
  • Patent 11,344,685

    Patent expiration dates:

    • September 26, 2039
      ✓ 
      Drug product
  • Patent 11344685*

    Patent expiration dates:

    • March 26, 2040
  • Patent 11,351,317

    Patent expiration dates:

    • February 10, 2038
      ✓ 
      Drug product
  • Patent 11351317*

    Patent expiration dates:

    • August 10, 2038
  • Patent 11,357,935

    Patent expiration dates:

    • September 24, 2038
      ✓ 
      Drug product
  • Reservoir pressure system for medicament inhaler
    Patent 7,540,282
    Issued: June 2, 2009
    Inventor(s): O'Leary; David
    Assignee(s): Norton Healthcare Ltd

    An inhaler includes an accurate and consistent mechanical dose metering system that dispenses dry powdered medicament in discrete amounts or doses for patient inhalation, a pressure relief system that manages pressure within a medicament reservoir of the inhaler to ensure consistently dispensed doses, and a dose counting system indicating the number of doses remaining in the inhaler.

    Patent expiration dates:

    • May 6, 2023
      ✓ 
      Drug product
    • November 6, 2023
      ✓ 
      Pediatric exclusivity
  • Dry powder inhalation apparatus
    Patent 8,651,103
    Issued: February 18, 2014
    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 (4) normally held adjacent a reservoir for receiving medicament in a cup or receptacle (15) 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 (4) is achieved by a yoke acting on an abutment (16) thereof. Spillage of medicament in the apparatus is avoided.

    Patent expiration dates:

    • March 26, 2028
      ✓ 
      Drug product
    • September 26, 2028
      ✓ 
      Pediatric exclusivity
  • Airflow adaptor for a breath-actuated dry powder inhaler
    Patent 8,714,149
    Issued: May 6, 2014
    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 25, 2032
      ✓ 
      Drug product
    • August 25, 2032
      ✓ 
      Pediatric exclusivity
  • Dose counters for inhalers, inhalers and methods of assembly thereof
    Patent 8,978,966
    Issued: March 17, 2015
    Assignee(s): Teva Pharmaceuticals Ireland Norton Waterford IVAX Pharmaceuticals Ireland

    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
    • July 13, 2032
      ✓ 
      Pediatric exclusivity
  • Dry powder inhaler
    Patent 9,066,957
    Issued: June 30, 2015
    Assignee(s): TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.

    This invention provides a dry powder inhaler comprising: a dry powder medicament comprising fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of salmeterol per actuation is less than 50 μg; and wherein the dose provides a baseline-adjusted FEV1 in a patient of more than 150 mL within 30 minutes of receiving the dose. A method of treating a patient includes administering to a patient a dry powder medicament having fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of salmeterol per actuation is less than 50 μg; and wherein the dose provides a baseline-adjusted FEV1 in a patient of more than 150 mL within 30 minutes of receiving the dose.

    Patent expiration dates:

    • October 6, 2034
      ✓ 
      Patent use: TREATMENT OF ASTHMA
      ✓ 
      Drug product
    • April 6, 2035
      ✓ 
      Pediatric exclusivity
  • Dose counters for inhalers, inhalers and methods of assembly thereof
    Patent 9,216,260
    Issued: December 22, 2015
    Assignee(s): IVAX Pharmaceuticals Ireland Norton Waterford Teva Pharmaceuticals Ireland

    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
    • December 28, 2031
      ✓ 
      Pediatric exclusivity
  • Dry powder inhaler
    Patent 9,415,008
    Issued: August 16, 2016
    Assignee(s): Teva Branded Pharmaceutical Products R&D, Inc.

    This invention provides a dry powder inhaler comprising: a dry powder medicament comprising fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of fluticasone propionate per actuation is less than 100 μg; and wherein the dose provides a baseline-adjusted FEV1 in a patient of more than 150 mL within 30 minutes of receiving the dose. A method of treating a patient includes administering to a patient a dry powder medicament having fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of fluticasone propionate per actuation is less than 100 μg; and wherein the dose provides a baseline-adjusted FEV1 in a patient of more than 150 mL within 30 minutes of receiving the dose.

    Patent expiration dates:

    • October 6, 2034
      ✓ 
      Patent use: TREATMENT OF ASTHMA
      ✓ 
      Drug product
    • April 6, 2035
      ✓ 
      Pediatric exclusivity
  • Dry powder inhalation apparatus
    Patent 9,463,288
    Issued: October 11, 2016
    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
    • November 19, 2025
      ✓ 
      Pediatric exclusivity
  • Process for preparing a medicament
    Patent 9,616,024
    Issued: April 11, 2017
    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
    • March 1, 2025
      ✓ 
      Pediatric exclusivity
  • Dose counter for inhaler having a bore and shaft arrangement
    Patent 9,731,087
    Issued: August 15, 2017
    Assignee(s): IVAX PHARMACEUTICALS IRELAND TEVA PHARMACEUTICALS IRELAND NORTON (WATERFORD) LIMITED

    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
    • November 18, 2031
      ✓ 
      Pediatric exclusivity
  • Compliance monitoring module for a breath-actuated inhaler
    Patent 9,782,550
    Issued: October 10, 2017
    Assignee(s): MicroDose Therapeutx, Inc. 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 28, 2035
      ✓ 
      Drug product
    • February 28, 2036
      ✓ 
      Pediatric exclusivity
  • Compliance monitoring module for a breath-actuated inhaler
    Patent 9,782,551
    Issued: October 10, 2017
    Assignee(s): MicroDose Therapeutx, Inc. 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 28, 2035
      ✓ 
      Drug product
    • February 28, 2036
      ✓ 
      Pediatric exclusivity
  • Process for preparing a medicament
    Patent 9,987,229
    Issued: June 5, 2018
    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
    • March 1, 2025
      ✓ 
      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 - REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
    • 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.