ALBUTEROL SULFATE - Generic Drug Details

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, Padagis Us, Sandoz Inc, Teva Branded Pharm, Kindeva, Glaxosmithkline, Mylan Speciality Lp, Actavis Mid Atlantic, Akorn, Apotex Inc, Bausch And Lomb, 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 Rx, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Rising, Muro, Strides Pharma, Am Therap, Amneal Pharms Co, Appco, 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-one 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-one patent family members in thirty-two countries.

There are eleven 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:	451
US Patents:	31
Tradenames:	16
Applicants:	50
NDAs:	99
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	43
Patent Applications:	6,846
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
Aurobindo Pharma Ltd	Phase 3
Wake Forest University Health Sciences	Early Phase 1
Teva Branded Pharmaceutical Products R&D, Inc.	Early Phase 1

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
Cosette	ALBUTEROL SULFATE	albuterol sulfate	SYRUP;ORAL	074454-001	Sep 25, 1995	AA	RX	No	No
Am Therap	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072450-001	Dec 5, 1989		DISCN	No	No
Eywa	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	213524-002	Oct 8, 2020		DISCN	No	No
Copley Pharm	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072967-001	Nov 22, 1991		DISCN	No	No
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	AB2	RX	Yes	Yes			Y
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	BX	RX	Yes	Yes					Y
Appco	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	210948-002	Mar 15, 2019	AB	RX	No	No

Expired US Patents for ALBUTEROL SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	PROVENTIL	albuterol sulfate	SYRUP;ORAL	018062-001	Jan 19, 1983
Mylan Speciality Lp	ACCUNEB	albuterol sulfate	SOLUTION;INHALATION	020949-001	Apr 30, 2001
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-001	Dec 23, 1992
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-002	Dec 23, 1992
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015
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

International Patents for ALBUTEROL SULFATE

Country	Patent Number	Title	Estimated Expiration
Australia	2001270113
Denmark	1667627
United Kingdom	2365778	Dose metering system for medicament inhaler
Mexico	339742	CONTADORES DE DOSIS PARA INHALADORES, INHALADORES Y FLECHAS DE LOS MISMOS. (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF.)
Japan	2010523184
Spain	2544278
Cyprus	1113531