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Serving 500+ biopharmaceutical companies globally:

McKinsey
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Harvard Business School
McKesson
Moodys
Baxter
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Cipla
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Generated: September 22, 2017

DrugPatentWatch Database Preview

Albuterol sulfate - Generic Drug Details

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

Albuterol sulfate
is the generic ingredient in fifteen branded drugs marketed by Mova, 3m Drug Delivery, Muro, Vintage, Copley Pharm, Glaxosmithkline, Pliva, Apotex Inc, Warner Chilcott, Teva, Ucb Inc, Roxane, Watson Labs, Dava Pharms Inc, Actavis Mid Atlantic, Teva Branded Pharm, Sun Pharm Inds, Ritedose Corp, Amneal Pharms, Hi Tech Pharma, Teva Pharms, Schering, Mylan Speciality Lp, Am Therap, Bausch And Lomb, Sandoz, Mylan Speclt, G And W Labs Inc, Nephron, Sun Pharma Global, Landela Pharm, Watson Labs Inc, Vistapharm, Mylan, Wockhardt Eu Operatn, Boehringer Ingelheim, Cipla Ltd, Watson Labs Teva, and Sandoz Inc, and is included in eighty-four NDAs. There are fifty-two 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 eighty-six patent family members in forty-two countries.

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

Summary for Generic Name: albuterol sulfate

Tradenames:15
Patents:52
Applicants:39
NDAs:84
Drug Master File Entries: see list37
Suppliers / Packagers: see list42
Bulk Api Vendors: see list135
Clinical Trials: see list853
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:albuterol sulfate at DailyMed

Pharmacology for Ingredient: albuterol sulfate

Tentative approvals for ALBUTEROL SULFATE

Applicant Application No. Strength Dosage Form
► Subscribe► SubscribeEQ 0.083% BASE;0.017%SOLUTION;INHALATION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering
PROVENTIL
albuterol sulfate
SOLUTION;INHALATION019243-002Jan 14, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
ALBUTEROL SULFATE
albuterol sulfate
TABLET;ORAL072630-001Jan 31, 1991DISCNNoNo► Subscribe► Subscribe► Subscribe
Copley Pharm
ALBUTEROL SULFATE
albuterol sulfate
SOLUTION;INHALATION073307-001Nov 27, 1991DISCNNoNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 2001BXRXYesYes► Subscribe► SubscribeY► Subscribe
Teva Branded Pharm
PROAIR RESPICLICK
albuterol sulfate
POWDER, METERED;INHALATION205636-001Mar 31, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
COMBIVENT RESPIMAT
albuterol sulfate; ipratropium bromide
SPRAY, METERED;INHALATION021747-001Oct 7, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
DUONEB
albuterol sulfate; ipratropium bromide
SOLUTION;INHALATION020950-001Mar 21, 2001DISCNYesNo► Subscribe► Subscribe ► Subscribe
Wockhardt Eu Operatn
ALBUTEROL SULFATE
albuterol sulfate
SOLUTION;INHALATION075394-001Nov 22, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms
ALBUTEROL SULFATE
albuterol sulfate
SYRUP;ORAL079241-001May 12, 2010AARXNoNo► Subscribe► Subscribe► Subscribe
Mylan
ALBUTEROL SULFATE
albuterol sulfate
TABLET, EXTENDED RELEASE;ORAL078092-001Jan 29, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: albuterol sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Muro
VOLMAX
albuterol sulfate
TABLET, EXTENDED RELEASE;ORAL019604-002Dec 23, 1992► Subscribe► Subscribe
Glaxosmithkline
VENTOLIN
albuterol sulfate
TABLET;ORAL019112-002Jul 10, 1986► Subscribe► Subscribe
Muro
VOLMAX
albuterol sulfate
TABLET, EXTENDED RELEASE;ORAL019604-001Dec 23, 1992► Subscribe► Subscribe
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 2004► Subscribe► Subscribe
Glaxosmithkline
VENTOLIN
albuterol sulfate
TABLET;ORAL019112-001Jul 10, 1986► Subscribe► Subscribe
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 2001► Subscribe► Subscribe
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 2004► Subscribe► Subscribe
3m Drug Delivery
PROVENTIL-HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020503-001Aug 15, 1996► Subscribe► Subscribe
3m Drug Delivery
PROVENTIL-HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020503-001Aug 15, 1996► Subscribe► Subscribe
Schering
PROVENTIL
albuterol sulfate
SOLUTION;INHALATION019243-002Jan 14, 1987► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: albuterol sulfate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,737,674Dose counters for inhalers, inhalers and methods of assembly thereof► Subscribe
6,743,413 Suspension aerosol formulations► Subscribe
7,101,534Suspension aerosol formulations► Subscribe
5,290,539 Device for delivering an aerosol► Subscribe
9,526,850Dose counters for inhalers, inhalers and methods of assembly thereof► Subscribe
9,174,013Dose counters for inhalers, inhalers and methods of assembly thereof► Subscribe
6,656,453 Medicaments► Subscribe
9,108,010Dose counters for inhalers, inhalers and methods of assembly thereof► Subscribe
6,655,381 Pre-metered dose magazine for breath-actuated dry powder inhaler► Subscribe
6,030,682 Container for aerosol formulation► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: albuterol sulfate

Country Document Number Estimated Expiration
Germany69735247► Subscribe
African Regional IP Organization (ARIPO)988► Subscribe
Canada2098727► Subscribe
Japan2014128708► Subscribe
Austria415994► Subscribe
Japan5900932► Subscribe
Japan2000515536► Subscribe
European Patent Office2987523► Subscribe
Eurasian Patent Organization026245► Subscribe
Hong Kong1219069► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

McKesson
Fuji
Colorcon
Cantor Fitzgerald
Express Scripts
Deloitte
Fish and Richardson
Boehringer Ingelheim
Chinese Patent Office
Argus Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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