Albuterol - Generic Drug Details

What are the generic sources for albuterol and what is the scope of freedom to operate?

Albuterol is the generic ingredient in eighteen branded drugs marketed by Armstrong Pharms, Genpharm, Ivax Sub Teva Pharms, Pliva, Schering, Glaxosmithkline, Cipla, Lupin, Padagis Us, Sandoz, Teva Branded Pharm, Kindeva, Mylan Speciality Lp, Actavis Mid Atlantic, Apotex Inc, Bausch, Copley Pharm, Epic Pharma Llc, Landela Pharm, Luoxin Aurovitas, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sentiss, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, Chartwell Molecular, Chartwell Rx, Cosette, Hikma, Mova, Quagen, Teva, Rising, Muro, Strides Pharma, Aizant, Am Therap, Amneal Pharms Co, Aurobindo Pharma Ltd, Dash Pharms Natco, Eywa, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Astrazeneca, Boehringer Ingelheim, Fosun Pharma, and Watson Labs Teva, and is included in one hundred and six NDAs. There are thirty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for albuterol

US Patents:	35
Tradenames:	18
Applicants:	56
NDAs:	106
Drug Master File Entries:	38
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	282
Patent Applications:	6,615
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for albuterol
Drug Sales Revenues:	Drug sales revenues for albuterol
What excipients (inactive ingredients) are in albuterol?	albuterol excipients list
DailyMed Link:	albuterol at DailyMed

See drug prices for albuterol

See drug sales revenues for albuterol

Recent Clinical Trials for albuterol

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

Sponsor	Phase
Johns Hopkins University	Phase 3
Parexel	Phase 3
Norwegian School of Sport Sciences	N/A

See all albuterol clinical trials

Generic filers with tentative approvals for ALBUTEROL

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.

Medical Subject Heading (MeSH) Categories for albuterol

Adrenergic beta-2 Receptor Agonists

Bronchodilator Agents

Tocolytic Agents

US Patents and Regulatory Information for albuterol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Landela Pharm	ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	077569-001	Apr 4, 2006		DISCN	No	No
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015		RX	Yes	Yes			Y
Nephron	ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	076355-001	Jun 28, 2004	AN	RX	No	Yes
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		RX	Yes	No			Y
Hikma	ALBUTEROL SULFATE	albuterol sulfate	SYRUP;ORAL	074749-001	Jan 30, 1998	AA	RX	No	No
Ucb Inc	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	073121-001	Sep 29, 1992		DISCN	No	No
Watson Labs Teva	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	077063-001	Dec 31, 2007		DISCN	No	No

Expired US Patents for albuterol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	VENTOLIN	albuterol	AEROSOL, METERED;INHALATION	018473-001	Approved Prior to Jan 1, 1982
Glaxosmithkline	VENTOLIN	albuterol	AEROSOL, METERED;INHALATION	018473-001	Approved Prior to Jan 1, 1982
Schering	PROVENTIL	albuterol	AEROSOL, METERED;INHALATION	017559-001	Approved Prior to Jan 1, 1982
Schering	PROVENTIL	albuterol	AEROSOL, METERED;INHALATION	017559-001	Approved Prior to Jan 1, 1982