PROAIR HFA Drug Patent Profile
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Which patents cover Proair Hfa, and when can generic versions of Proair Hfa launch?
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-two 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.
Summary for PROAIR HFA
International Patents: | 212 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 81 |
Clinical Trials: | 14 |
Patent Applications: | 5,573 |
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 |
Recent Clinical Trials for PROAIR HFA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Teva Branded Pharmaceutical Products R&D, Inc. | Early Phase 1 |
University of North Carolina, Chapel Hill | Early Phase 1 |
Wake Forest University Health Sciences | 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dose counters for inhalers, inhalers and methods of assembly thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dose counter for inhaler and method for counting doses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Metered-dose inhaler
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dose counters for inhalers, inhalers and methods of assembly thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | AB2 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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
International Patents for PROAIR HFA
See the table below for patents covering PROAIR HFA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20130103823 | DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF | ⤷ Try a Trial |
Japan | 5497964 | ⤷ Try a Trial | |
Denmark | 2514467 | ⤷ Try a Trial | |
Greece | 3036467 | ⤷ Try a Trial | |
South Africa | 201307993 | DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF | ⤷ Try a Trial |
South Africa | 201307989 | DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |