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Generated: October 23, 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 four hundred and thirty-two 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

US Patents:52
Tradenames:15
Applicants:39
NDAs:84
Drug Master File Entries: see list37
Suppliers / Packagers: see list42
Bulk Api Vendors: see list135
Clinical Trials: see list860
Patent Applications: see list5,632
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
u► 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
Teva Branded Pharm
PROAIR RESPICLICK
albuterol sulfate
POWDER, METERED;INHALATION205636-001Mar 31, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Roxane
ALBUTEROL SULFATE
albuterol sulfate
SOLUTION;INHALATION075129-001Feb 13, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe
Nephron
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
albuterol sulfate; ipratropium bromide
SOLUTION;INHALATION076749-001Dec 31, 2007ANRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
ALBUTEROL SULFATE
albuterol sulfate
SOLUTION;INHALATION077772-002Sep 25, 2007ANRXNoNo► Subscribe► Subscribe► Subscribe
Dava Pharms Inc
VOSPIRE ER
albuterol sulfate
TABLET, EXTENDED RELEASE;ORAL076130-003Sep 26, 2002ABRXNoYes► Subscribe► Subscribe► Subscribe
Glaxosmithkline
VENTOLIN
albuterol sulfate
TABLET;ORAL019112-001Jul 10, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan
ALBUTEROL SULFATE
albuterol sulfate
TABLET;ORAL072894-001Jan 17, 1991ABRXNoYes► Subscribe► Subscribe► Subscribe
Watson Labs
ALBUTEROL SULFATE
albuterol sulfate
SYRUP;ORAL073165-001Apr 29, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
Muro
VOLMAX
albuterol sulfate
TABLET, EXTENDED RELEASE;ORAL019604-002Dec 23, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
albuterol sulfate; ipratropium bromide
SOLUTION;INHALATION077117-001Dec 31, 2007DISCNNoNo► 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
Glaxosmithkline
VENTOLIN
albuterol sulfate
SYRUP;ORAL019621-001Jun 10, 1987► Subscribe► Subscribe
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 2004► Subscribe► Subscribe
Schering
PROVENTIL
albuterol sulfate
TABLET, EXTENDED RELEASE;ORAL019383-001Jul 13, 1987► 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
Glaxosmithkline
VENTOLIN
albuterol sulfate
TABLET;ORAL019112-002Jul 10, 1986► Subscribe► Subscribe
Schering
PROVENTIL
albuterol sulfate
TABLET;ORAL017853-001May 7, 1982► Subscribe► Subscribe
3m Drug Delivery
PROVENTIL-HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020503-001Aug 15, 1996► Subscribe► Subscribe
Schering
PROVENTIL
albuterol sulfate
TABLET;ORAL017853-002May 7, 1982► Subscribe► Subscribe
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 2001► 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
6,656,453 Medicaments► Subscribe
5,290,539 Device for delivering an aerosol► Subscribe
7,101,534Suspension aerosol formulations► Subscribe
9,526,851Dose counters for inhalers, inhalers and methods of assembly thereof► Subscribe
9,174,013Dose counters for inhalers, inhalers and methods of assembly thereof► Subscribe
6,655,381 Pre-metered dose magazine for breath-actuated dry powder inhaler► Subscribe
9,526,850Dose counters for inhalers, inhalers and methods of assembly thereof► Subscribe
9,533,111Dose counters for inhalers, inhalers and methods of assembly thereof► Subscribe
6,030,682 Container for aerosol formulation► Subscribe
9,108,010Dose counters for inhalers, inhalers and methods of assembly thereof► 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
Spain2544501► Subscribe
World Intellectual Property Organization (WIPO)0197889► Subscribe
Japan5497964► Subscribe
Cyprus1116358► Subscribe
Canada2464660► Subscribe
Eurasian Patent Organization016831► Subscribe
New Zealand241170► Subscribe
Germany69729485► Subscribe
TaiwanI224512► Subscribe
Mexico339742► 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 leading biopharmaceutical companies globally:

Deloitte
McKinsey
Medtronic
Johnson and Johnson
Julphar
Fuji
Novartis
Daiichi Sankyo
AstraZeneca
Chinese Patent Office

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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