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ALBUTEROL SULFATE - Generic Drug Details

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What are the generic sources for albuterol sulfate and what is the scope of patent protection?

Albuterol sulfate is the generic ingredient in sixteen branded drugs marketed by Cipla, Lupin, Perrigo Pharms Co, Teva Branded Pharm, Kindeva, Glaxosmithkline, Mylan Speciality Lp, Actavis Mid Atlantic, Akorn, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Landela Pharm, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Schering, Amneal Pharms, Chartwell Rx, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Mylan, Muro, Dava Pharms Inc, Aizant, Am Therap, Amneal Pharms Co, Eywa, Pliva, Rising, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Yaopharma Co Ltd, Zydus Pharms, Boehringer Ingelheim, Fosun Pharma, and Watson Labs Teva, and is included in ninety-eight NDAs. There are thirty-eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate has four hundred and fifty-seven patent family members in thirty-two countries.

There are thirty-eight drug master file entries for albuterol sulfate. Forty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ALBUTEROL SULFATE

International Patents:	457
US Patents:	38
Tradenames:	16
Applicants:	49
NDAs:	98
Drug Master File Entries:	38
Suppliers / Packagers:	41
Bulk Api Vendors:	60
Clinical Trials:	27
Patent Applications:	6,121
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ALBUTEROL SULFATE
Drug Sales Revenues:	Drug sales revenues for ALBUTEROL SULFATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALBUTEROL SULFATE
DailyMed Link:	ALBUTEROL SULFATE at DailyMed

See drug prices for ALBUTEROL SULFATE

See drug sales revenues for ALBUTEROL SULFATE

Recent Clinical Trials for ALBUTEROL SULFATE

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

Sponsor	Phase
University of California, Irvine	Phase 4
Sun Pharmaceutical Industries Limited	Phase 3
Amneal Ireland Limited	Phase 3

See all ALBUTEROL SULFATE clinical trials

Generic filers with tentative approvals for ALBUTEROL SULFATE

Applicant	Application No.	Strength	Dosage Form
		EQ 0.083% BASE;0.017%	SOLUTION;INHALATION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ALBUTEROL SULFATE

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

Paragraph IV (Patent) Challenges for ALBUTEROL SULFATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
PROVENTIL-HFA	AEROSOL, METERED;INHALATION	albuterol sulfate	020503	2015-05-20
PROAIR HFA	AEROSOL, METERED;INHALATION	albuterol sulfate	021457	2012-05-18
ACCUNEB	SOLUTION;INHALATION	albuterol sulfate	020949	2005-10-19
VENTOLIN	SYRUP;ORAL	albuterol sulfate	019621
VOLMAX	TABLET, EXTENDED RELEASE;ORAL	albuterol sulfate	019604

US Patents and Regulatory Information for ALBUTEROL SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	VENTOLIN	albuterol sulfate	TABLET;ORAL	019112-002	Jul 10, 1986		DISCN	No	No
Aurobindo Pharma Ltd	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	206532-001	Jul 8, 2020	AN	RX	No	No
Glaxosmithkline	VENTOLIN	albuterol sulfate	SOLUTION;INHALATION	019269-002	Jan 16, 1987		DISCN	No	No
Teva	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072938-001	Mar 30, 1990		DISCN	No	No
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015		RX	Yes	Yes			Y
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015		RX	Yes	Yes			Y

Expired US Patents for ALBUTEROL SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	VENTOLIN	albuterol sulfate	SYRUP;ORAL	019621-001	Jun 10, 1987
Schering	PROVENTIL	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019383-001	Jul 13, 1987
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-002	Dec 23, 1992
Schering	PROVENTIL	albuterol sulfate	SOLUTION;INHALATION	019243-002	Jan 14, 1987
Schering	PROVENTIL	albuterol sulfate	TABLET;ORAL	017853-002	May 7, 1982

International Patents for ALBUTEROL SULFATE

Country	Patent Number	Estimated Expiration
Cyprus	1115748
Japan	2014144353
Japan	2016025944
Taiwan	201617102
South Korea	20090127376
South Korea	100518723