PROAIR HFA Drug Patent Profile
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When do Proair Hfa patents expire, and what generic alternatives are available?
Proair Hfa is a drug marketed by Teva Branded Pharm and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and twelve patent family members in twenty-six countries.
The generic ingredient in PROAIR HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Proair Hfa
A generic version of PROAIR HFA was approved as albuterol sulfate by SUN PHARM INDUSTRIES on December 5th, 1989.
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Summary for PROAIR HFA
| International Patents: | 212 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 81 |
| Clinical Trials: | 14 |
| Patent Applications: | 5,404 |
| Drug Prices: | Drug price information for PROAIR HFA |
| Drug Sales Revenues: | Drug sales revenues for PROAIR HFA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PROAIR HFA |
| DailyMed Link: | PROAIR HFA at DailyMed |
See drug prices for PROAIR HFA
Recent Clinical Trials for PROAIR HFA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of North Carolina, Chapel Hill | Early Phase 1 |
| Wake Forest University Health Sciences | Early Phase 1 |
| Teva Branded Pharmaceutical Products R&D, Inc. | Early Phase 1 |
Pharmacology for PROAIR HFA
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
Paragraph IV (Patent) Challenges for PROAIR HFA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PROAIR HFA | Inhalation Aerosol | albuterol sulfate | 0.09 mg base per actuation | 021457 | 1 | 2012-05-18 |
US Patents and Regulatory Information for PROAIR HFA
PROAIR HFA is protected by nine US patents.
Patents protecting PROAIR HFA
Dose counter for inhaler having a bore and shaft arrangement
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dose counters for inhalers, inhalers and methods of assembly thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dose counter for inhaler and method for counting doses
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Metered-dose inhaler
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dose counters for inhalers, inhalers and methods of assembly thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dose counter for inhaler having an anti-reverse rotation actuator
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Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for PROAIR HFA
International Patents for PROAIR HFA
See the table below for patents covering PROAIR HFA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Israel | 223117 | מוני מינון למשאפים ומשאפים ועמודים למשאפים (Dose counters for inhalers and inhalers and shafts thereof) | ⤷ Sign Up |
| South Korea | 20130101169 | ⤷ Sign Up | |
| Japan | 2016041380 | 吸入器のための用量カウンタ、吸入器及びそのシャフト (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF) | ⤷ Sign Up |
| South Africa | 201509290 | ⤷ Sign Up | |
| South Korea | 101718674 | ⤷ Sign Up | |
| South Korea | 20130103827 | DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF | ⤷ Sign Up |
| Poland | 2514466 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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