PROAIR HFA Drug Patent Profile

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.

The generic ingredient in PROAIR HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-six 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.

Summary for PROAIR HFA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	14
Patent Applications:	6,177
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
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

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

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	5,766,573
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	8,834,849
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	5,605,674
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	7,105,152
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	6,352,684
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	7,566,445

International Patents for PROAIR HFA

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

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201300232	ВАЛ ДЛЯ УДЕРЖИВАНИЯ ЛЕНТЫ СЧЕТЧИКА В СЧЕТЧИКЕ ДОЗ, СБОРОЧНЫЙ УЗЕЛ ВАЛА И ЛЕНТЫ СЧЕТЧИКА, СЧЕТЧИК ДОЗ ДЛЯ ИНГАЛЯТОРА И ИНГАЛЯТОР ДЛЯ ВДЫХАНИЯ ЛЕКАРСТВЕННОГО ВЕЩЕСТВА
Hong Kong	1221920
Japan	2013526353
Japan	6273242
Eurasian Patent Organization	024635
Eurasian Patent Organization	026306	СПОСОБ СБОРКИ СЧЕТЧИКА ДОЗ ДЛЯ ИНГАЛЯТОРА И ЛЕНТОЧНАЯ СИСТЕМА (METHOD FOR ASSEMBLY OF A DOSE COUNTER FOR AN INHALER, AND A TAPE SYSTEM)