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
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015		RX	Yes	Yes			Y
Glaxosmithkline	VENTOLIN ROTACAPS	albuterol sulfate	CAPSULE;INHALATION	019489-001	May 4, 1988		DISCN	No	No
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	AB2	RX	Yes	Yes			Y
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes			Y
Glaxosmithkline	VENTOLIN	albuterol sulfate	SOLUTION;INHALATION	019269-002	Jan 16, 1987		DISCN	No	No
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	AB2	RX	Yes	Yes			Y
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-001	Dec 23, 1992		DISCN	Yes	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