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 5^th, 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

Drug patent expirations by year for PROAIR HFA

Recent Clinical Trials for PROAIR HFA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wake Forest University Health Sciences	Early Phase 1
Teva Branded Pharmaceutical Products R&D, Inc.	Early Phase 1
University of North Carolina, Chapel Hill	Early Phase 1

See all PROAIR HFA clinical trials

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
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Patent Expiration: ⤷ Sign Up

Dose counters for inhalers, inhalers and methods of assembly thereof
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Patent Expiration: ⤷ Sign Up

Dose counter for inhaler and method for counting doses
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Patent Expiration: ⤷ Sign Up

Dose counter for inhaler having an anti-reverse rotation actuator
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Patent Expiration: ⤷ Sign Up

Metered-dose inhaler
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Patent Expiration: ⤷ Sign Up

Dose counters for inhalers, inhalers and methods of assembly thereof
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Patent Expiration: ⤷ Sign Up

Dose counter for inhaler having an anti-reverse rotation actuator
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Glossary

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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
>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

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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	⤷ Sign Up	⤷ Sign Up
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	⤷ Sign Up	⤷ Sign Up
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PROAIR HFA

See the table below for patents covering PROAIR HFA around the world.

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Country	Patent Number	Title	Estimated Expiration
South Korea	101628934		⤷ Sign Up
South Korea	20130103825	DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF	⤷ Sign Up
Poland	2514465		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration