Albuterol sulfate - Generic Drug Details

What are the generic drug 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, Padagis Us, Sandoz Inc, Teva Branded Pharm, Kindeva, Glaxosmithkline, Mylan Speciality Lp, Actavis Mid Atlantic, Akorn, Apotex Inc, Bausch, Copley Pharm, Landela Pharm, Luoxin Aurovitas, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Schering, Amneal Pharms, Chartwell Molecular, Chartwell Rx, Cosette, Mova, Quagen, Teva, Rising, Muro, Strides Pharma, Aizant, Am Therap, Amneal Pharms Co, Aurobindo Pharma Ltd, Eywa, Mylan, Pliva, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Boehringer Ingelheim, Fosun Pharma, and Watson Labs Teva, and is included in ninety-nine NDAs. There are thirty-seven 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 ninety-six patent family members in thirty-two countries.

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

Summary for albuterol sulfate

International Patents:	496
US Patents:	37
Tradenames:	16
Applicants:	50
NDAs:	99
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	44
Patent Applications:	6,901
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
What excipients (inactive ingredients) are in albuterol sulfate?	albuterol sulfate excipients list
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
Bond Avillion 2 Development LP	Phase 3
Parexel	Phase 3
Aurobindo Pharma Ltd	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	Strength	NDA	ANDAs Submitted	Submissiondate
PROVENTIL-HFA	Inhalation Aerosol	albuterol sulfate	0.09 mg base per actuation	020503	1	2015-05-20
PROAIR HFA	Inhalation Aerosol	albuterol sulfate	0.09 mg base per actuation	021457	1	2012-05-18
ACCUNEB	Inhalation Solution	albuterol sulfate	0.021%	020949	1	2005-10-19
ACCUNEB	Inhalation Solution	albuterol sulfate	0.042%	020949	1	2004-04-06

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
Boehringer Ingelheim	COMBIVENT	albuterol sulfate; ipratropium bromide	AEROSOL, METERED;INHALATION	020291-001	Oct 24, 1996		DISCN	No	No
Bausch	ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	075358-001	Mar 29, 2000		DISCN	No	No
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		RX	Yes	No			Y
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 sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004
Schering	PROVENTIL	albuterol sulfate	TABLET;ORAL	017853-001	May 7, 1982
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-001	Dec 23, 1992

International Patents for albuterol sulfate

Country	Patent Number	Title	Estimated Expiration
Taiwan	201617102	Compliance monitoring module for a breath-actuated inhaler
Argentina	028747	DESAGLOMERADOR PARA INHALADOR DE POLVO SECO ACCIONADO POR LA RESPIRACION, UN INHALADOR DE POLVO SECO Y UN METODO DE DESAGLOMERACION DE POLVO SECO.
Australia	2020200884	Compliance monitoring module for a breath-actuated inhaler
Spain	2811842