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PROAIR HFA Drug 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.
This drug has two hundred and forty-one patent family members in twenty-eight countries.
The generic ingredient in PROAIR HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
US ANDA 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.
Summary for PROAIR HFA
International Patents: | 241 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 10 |
Bulk Api Vendors: | 60 |
Clinical Trials: | 8 |
Patent Applications: | 3,939 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Sun Pharmaceutical Industries Limited | Phase 3 |
Amneal Ireland Limited | Phase 3 |
Oregon Health and Science University | Phase 4 |
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 | NDA | Submissiondate |
---|---|---|---|---|
PROAIR HFA | AEROSOL, METERED;INHALATION | albuterol sulfate | 021457 | 2012-05-18 |
US Patents and Regulatory Information for PROAIR HFA
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 | Start Trial | Start Trial | Y | Start Trial | ||
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | Start Trial | Start Trial |
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | Start Trial | Start Trial |
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | Start Trial | Start Trial |
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | Start Trial | Start Trial |
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROAIR HFA
Country | Patent Number | Estimated Expiration |
---|---|---|
China | 105903113 | Start Trial |
Spain | 2175413 | Start Trial |
European Patent Office | 2514466 | Start Trial |
Slovenia | 2436414 | Start Trial |
Hong Kong | 1223311 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |