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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 thirty-six patent family members in forty-two countries.

There are thirty-five drug master file entries for albuterol sulfate. Forty-one 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 list41
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

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
Glaxosmithkline
VENTOLIN
albuterol sulfate
SYRUP;ORAL019621-001Jun 10, 1987DISCNNo<disabled><disabled>
Am Therap
ALBUTEROL SULFATE
albuterol sulfate
TABLET;ORAL072449-001Dec 5, 1989DISCNNo<disabled><disabled>
Teva Branded Pharm
PROAIR RESPICLICK
albuterol sulfate
POWDER, METERED;INHALATION205636-001Mar 31, 2015RXYes6,446,627<disabled>Y <disabled>
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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 HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 20016,131,566*PED<disabled>
3m
PROVENTIL-HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020503-001Aug 15, 19966,352,684<disabled>
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 20016,532,955*PED<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
6,655,381 Pre-metered dose magazine for breath-actuated dry powder inhaler<disabled in preview>
7,101,534Suspension aerosol formulations<disabled in preview>
6,036,942 Seal configuration for aerosol canister<disabled in preview>
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International Patent Family for Ingredient: albuterol sulfate

Country Document Number Estimated Expiration
Germany60107107<disabled in preview>
Uruguay26796<disabled in preview>
European Patent Office0717987<disabled in preview>
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