Proair Hfa Patent Expiration

Proair Hfa is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is protected by 14 US drug patents filed from 2013 to 2022. Out of these, 9 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 01, 2032. Details of Proair Hfa's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10561808 Dose counter for inhaler having an anti-reverse rotation actuator
Jan, 2032

(7 years from now)

Active
US9463289 Dose counters for inhalers, inhalers and methods of assembly thereof
May, 2031

(6 years from now)

Active
US10022510 Dose counters for inhalers, inhalers and methods of assembly thereof
May, 2031

(6 years from now)

Active
US10086156 Dose counter for inhaler and method for counting doses
May, 2031

(6 years from now)

Active
US10695512 Dose counter for inhaler having an anti-reverse rotation actuator
May, 2031

(6 years from now)

Active
US11395889 Dose counter for inhaler having an anti-reverse rotation actuator
May, 2031

(6 years from now)

Active
US10022509 Dose counter for inhaler having a bore and shaft arrangement
May, 2031

(6 years from now)

Active
US9808587 Dose counter for inhaler having an anti-reverse rotation actuator
May, 2031

(6 years from now)

Active
US8132712 Metered-dose inhaler
Sep, 2028

(3 years from now)

Active
US7105152 Suspension aerosol formulations
Sep, 2023

(1 year, 2 months ago)

Expired
US6446627 Inhaler dose counter
Dec, 2017

(6 years ago)

Expired
US7566445 Medicinal aerosols and methods of delivery thereof
Jun, 2017

(7 years ago)

Expired
US8834849 Medicinal aerosols and methods of delivery thereof
Jun, 2017

(7 years ago)

Expired
US5605674 Medicinal aerosol formulations
Feb, 2014

(10 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Proair Hfa's patents.

Given below is the list of recent legal activities going on the following patents of Proair Hfa.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 21 Mar, 2024 US9463289
Payment of Maintenance Fee, 4th Year, Large Entity 22 Nov, 2023 US10695512
Payment of Maintenance Fee, 12th Year, Large Entity 23 Aug, 2023 US8132712
Payment of Maintenance Fee, 4th Year, Large Entity 20 Jul, 2023 US10561808
Expire Patent 24 Oct, 2022 US8834849
Patent Issue Date Used in PTA Calculation 26 Jul, 2022 US11395889
Recordation of Patent Grant Mailed 26 Jul, 2022 US11395889
Email Notification 03 Jul, 2022 US11395889
Issue Notification Mailed 02 Jul, 2022 US11395889
Dispatch to FDC 22 Jun, 2022 US11395889


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Proair Hfa and ongoing litigations to help you estimate the early arrival of Proair Hfa generic.

Proair Hfa's Litigations

Proair Hfa been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 26, 2018, against patent number US10561808. The petitioner , challenged the validity of this patent, with Declan Walsh et al. as the respondent. Click below to track the latest information on how companies are challenging Proair Hfa's patents.

Last updated on November 19, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10561808 October, 2018 Decision
(20 Sep, 2019)
Declan Walsh et al.


FDA has granted some exclusivities to Proair Hfa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Proair Hfa, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Proair Hfa.

Exclusivity Information

Proair Hfa holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Proair Hfa's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Sep 16, 2011

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US patents provide insights into the exclusivity only within the United States, but Proair Hfa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Proair Hfa's family patents as well as insights into ongoing legal events on those patents.

Proair Hfa's Family Patents

Proair Hfa has patent protection in a total of 26 countries. It's US patent count contributes only to 13.9% of its total global patent coverage. 5 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Proair Hfa.

Family Patents

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Generic Launch

Generic Release Date:

Proair Hfa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 01, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Proair Hfa Generic API suppliers:

Albuterol Sulfate is the generic name for the brand Proair Hfa. 46 different companies have already filed for the generic of Proair Hfa, with Teva having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Proair Hfa's generic

How can I launch a generic of Proair Hfa before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Proair Hfa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Proair Hfa's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Proair Hfa -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
0.09 mg base per actuation 18 May, 2012 1 24 Feb, 2020 12 Sep, 2023 Non-Forfeiture Deferred

Alternative Brands for Proair Hfa

There are several other brand drugs using the same active ingredient (Albuterol Sulfate) as Proair Hfa. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Astrazeneca
Airsupra
Boehringer Ingelheim
Combivent
Combivent Respimat
Glaxosmithkline
Ventolin Hfa
Kindeva
Proventil-hfa
Norvium Bioscience
Accuneb
Duoneb
Teva Branded Pharm
Proair Digihaler
Proair Respiclick


Apart from brand drugs containing the same ingredient, some generics have also been filed for Albuterol Sulfate, Proair Hfa's active ingredient. Check the complete list of approved generic manufacturers for Proair Hfa





About Proair Hfa

Proair Hfa is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. Proair Hfa uses Albuterol Sulfate as an active ingredient. Proair Hfa was launched by Teva Branded Pharm in 2004.

Approval Date:

Proair Hfa was approved by FDA for market use on 29 October, 2004.

Active Ingredient:

Proair Hfa uses Albuterol Sulfate as the active ingredient. Check out other Drugs and Companies using Albuterol Sulfate ingredient

Dosage:

Proair Hfa is available in aerosol, metered form for inhalation use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 0.09MG BASE/INH AEROSOL, METERED Prescription INHALATION


Proair Hfa News

Legal case involving Teva's pharmaceutical research and development division and Deva Holding A.S. over ProAir® HFA (albuterol sulfate)

06 Nov, 2024

Teva Unsuccessful in Inhaler Patent Lawsuit Against Amneal, Required to Modify Orange Book Entry

12 Jun, 2024

During FTC crackdown, judge finds Teva inhaler patents not listed correctly in FDA Orange Book

12 Jun, 2024

FTC considers Teva's inhaler lawsuit against Amneal in the midst of broad patent enforcement efforts

25 Mar, 2024

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