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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5605674 | Medicinal aerosol formulations |
Feb, 2014
(10 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
|
| US6446627 | Inhaler dose counter |
Dec, 2017
(6 years ago) |
Expired
|
| US7105152 | Suspension aerosol formulations |
Sep, 2023
(10 months ago) |
Expired
|
| US8132712 | Metered-dose inhaler |
Sep, 2028
(4 years from now) | Active |
| US9808587 | Dose counter for inhaler having an anti-reverse rotation actuator |
May, 2031
(6 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 |
| US10561808 | Dose counter for inhaler having an anti-reverse rotation actuator |
Jan, 2032
(7 years from now) | Active |
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.
Latest Legal Activities on Proair Hfa's Patents
Given below is the list of recent legal activities going on the following patents of Proair Hfa.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 has 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 or infringement 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10561808 | October, 2018 | Decision | 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 |
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
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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 Generics:
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 |
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.
Market Authorisation 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 |