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Albuterol sulfate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for albuterol sulfate?

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, Watson Labs Teva, and Sandoz Inc, and is included in eighty-two 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 fifty-eight 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.

Summary for Generic Name: albuterol sulfate

Tradenames:15
Patents:53
Applicants:37
NDAs:82
Drug Master File Entries: see list37
Suppliers / Packagers: see list42
Bulk Api Vendors: see list135
Clinical Trials: see list366
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

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 2001RXYesYes6,431,168*PED► SubscribeY► Subscribe
Nephron
ALBUTEROL SULFATE
albuterol sulfate
SOLUTION;INHALATION076355-001Jun 28, 2004RXNoNo► Subscribe► Subscribe
Glaxosmithkline
VENTOLIN
albuterol sulfate
TABLET;ORAL019112-001Jul 10, 1986DISCNNoNo► Subscribe► Subscribe
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 2004RXYesYes8,132,712► SubscribeY ► Subscribe
Hi Tech Pharma
ALBUTEROL SULFATE
albuterol sulfate
SOLUTION;INHALATION074543-001Jan 15, 1998RXNoNo► 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
Schering
PROVENTIL
albuterol sulfate
SOLUTION;INHALATION019243-001Jan 14, 19873,644,353► Subscribe
Muro
VOLMAX
albuterol sulfate
TABLET, EXTENDED RELEASE;ORAL019604-001Dec 23, 19924,777,049► Subscribe
Schering
PROVENTIL
albuterol sulfate
TABLET, EXTENDED RELEASE;ORAL019383-001Jul 13, 19873,644,353► Subscribe
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 20016,251,368► Subscribe
Glaxosmithkline
VENTOLIN
albuterol sulfate
TABLET;ORAL019112-002Jul 10, 19863,705,233► 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
7,101,534Suspension aerosol formulations► 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
9,526,851Dose counters for inhalers, inhalers and methods of assembly thereof► Subscribe
9,533,111Dose 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
TaiwanI224512► Subscribe
Yugoslavia49329► Subscribe
South Korea100663113► Subscribe
China105903110► Subscribe
Portugal1086688► 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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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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