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Albuterol sulfate - Generic Drug Details

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Albuterol sulfate is the generic ingredient in fifteen branded drugs marketed by Mova, 3M, 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 Speclt, Am Therap, Bausch And Lomb, Sandoz, G And W Labs Inc, Nephron, Landela Pharm, Watson Labs Inc, Vistapharm, Mylan, Wockhardt Eu Operatn, Boehringer Ingelheim, Cipla Ltd, and Sandoz Inc, and is included in eighty-three 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.

This ingredient has three hundred and sixty-three patent family members in forty-two countries.

There are thirty-five drug master file entries for albuterol sulfate. Forty-three suppliers are listed for this compound.

Summary for Generic Name: albuterol sulfate

Tradenames:15
Patents:52
Applicants:36
NDAs:83
Drug Master File Entries: see list35
Suppliers / Packaging: see list43
Therapeutic Class:Respiratory Tract Agents
Drug Prices:see low prices

Pharmacology for Ingredient: albuterol sulfate

Clinical Trials for: albuterol sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nephron
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
albuterol sulfate; ipratropium bromide
SOLUTION;INHALATION076749-001Dec 31, 2007RXNo
Dava Pharms Inc
ALBUTEROL SULFATE
albuterol sulfate
TABLET;ORAL072860-001Dec 20, 1989DISCNNo
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 2001RXYes6,997,349*PEDJul 16, 2018Y
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Expired Orange Book Patents for Generic Ingredient: albuterol sulfate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
VENTOLIN
albuterol sulfate
TABLET;ORAL019112-001Jul 10, 19863,705,233<disabled>
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 20016,596,260*PED<disabled>
Schering
PROVENTIL
albuterol sulfate
SYRUP;ORAL018062-001Jan 19, 19833,705,233<disabled>
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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
7,101,534Suspension aerosol formulations<disabled in preview>
9,108,010Dose counters for inhalers, inhalers and methods of assembly thereof<disabled in preview>
9,174,013Dose counters for inhalers, inhalers and methods of assembly thereof<disabled in preview>
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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
Spain2520966<disabled in preview>
Denmark1415934<disabled in preview>
Portugal2502644<disabled in preview>
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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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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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