Albuterol sulfate - Generic Drug Details

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

Albuterol sulfate is the generic ingredient in seventeen branded drugs marketed by Armstrong Pharms, Cipla, Lupin, Padagis Us, Sandoz, Teva Branded Pharm, Kindeva, Glaxosmithkline, Norvium Bioscience, Actavis Mid Atlantic, Apotex Inc, Bausch, Copley Pharm, Epic Pharma Llc, Landela Pharm, Lexenpharm, Luoxin Aurovitas, Nephron, Ritedose Corp, Roxane, Sentiss, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Schering, 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, Hibrow Hlthcare, Pliva, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Astrazeneca, Boehringer Ingelheim, Aiping Pharm Inc, and Watson Labs Teva, and is included in one hundred and two NDAs. There are thirty-five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate has three hundred and sixty-three patent family members in twenty-nine countries.

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

Summary for albuterol sulfate

International Patents:	363
US Patents:	35
Tradenames:	17
Applicants:	54
NDAs:	102
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	46
Patent Applications:	6,250
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

Drug Sales Revenue Trends 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
Parexel	Phase 3
Bond Avillion 2 Development LP	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
⤷ Sign Up	⤷ Sign Up	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Virtus Pharm	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	211397-002	Oct 26, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex Inc	ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	078623-001	Apr 5, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Schering	PROVENTIL	albuterol sulfate	SYRUP;ORAL	018062-001	Jan 19, 1983		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Schering	PROVENTIL	albuterol sulfate	TABLET;ORAL	017853-001	May 7, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ucb Inc	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	073121-001	Sep 29, 1992		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	AB2	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Am Therap	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072449-001	Dec 5, 1989		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for albuterol sulfate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	VENTOLIN	albuterol sulfate	TABLET;ORAL	019112-002	Jul 10, 1986	⤷ Sign Up	⤷ Sign Up
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996	⤷ Sign Up	⤷ Sign Up
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	⤷ Sign Up	⤷ Sign Up
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018	⤷ Sign Up	⤷ Sign Up
Schering	PROVENTIL	albuterol sulfate	SYRUP;ORAL	018062-001	Jan 19, 1983	⤷ Sign Up	⤷ Sign Up
Schering	PROVENTIL	albuterol sulfate	TABLET;ORAL	017853-001	May 7, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for albuterol sulfate

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021007154		⤷ Sign Up
Israel	263904		⤷ Sign Up
Eurasian Patent Organization	200970907	ДОЗИРУЮЩИЙ ИНГАЛЯТОР	⤷ Sign Up
European Patent Office	3057637	MODULE DE SURVEILLANCE DE LA CONFORMITÉ POUR UN INHALATEUR ACTIONNÉ PAR LA RESPIRATION (COMPLIANCE MONITORING MODULE FOR A BREATH-ACTUATED INHALER)	⤷ Sign Up
Brazil	112017003868	módulo de monitoração de conformidade para inaladores acionados pela respiração, inaladores que o contenham, método de utilização e programa de computador para execução do método.	⤷ Sign Up
Eurasian Patent Organization	037224	ИНГАЛЯЦИОННОЕ УСТРОЙСТВО СО ВСТРОЕННЫМ ЭЛЕКТРОННЫМ МОДУЛЕМ (INHALATION DEVICE WITH INTEGRATED ELECTRONICS MODULE)	⤷ Sign Up
Japan	7311563		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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