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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 5^th, 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

See drug sales revenues 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

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	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			Y
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	AB2	RX	Yes	Yes			Y
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	AB2	RX	Yes	Yes			Y
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	AB2	RX	Yes	Yes			Y
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	AB2	RX	Yes	Yes			Y

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
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004

International Patents for PROAIR HFA

Country	Patent Number	Estimated Expiration
China	105903113
Spain	2175413
European Patent Office	2514466
Slovenia	2436414
Hong Kong	1223311