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Serving 500+ biopharmaceutical companies globally:

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Generated: July 25, 2017

DrugPatentWatch Database Preview

Amoxicillin; clavulanate potassium - Generic Drug Details

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What are the generic drug sources for amoxicillin; clavulanate potassium and what is the scope of amoxicillin; clavulanate potassium patent protection?

Amoxicillin; clavulanate potassium
is the generic ingredient in nine branded drugs marketed by Teva, Sun Pharm Inds Ltd, Micro Labs Ltd India, Apotex Inc, Sandoz Inc, Wockhardt Eu Operatn, Dr Reddys Labs Inc, Hikma Pharms, Sandoz, Wockhardt, Aurobindo Pharma Ltd, and Teva Pharms Usa, and is included in forty-one NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Amoxicillin; clavulanate potassium has ninety-four patent family members in forty-eight countries.

There are forty-four drug master file entries for amoxicillin; clavulanate potassium. Forty-six suppliers are listed for this compound.

Summary for Generic Name: amoxicillin; clavulanate potassium

Tradenames:9
Patents:6
Applicants:12
NDAs:41
Drug Master File Entries: see list44
Suppliers / Packagers: see list46
Bulk Api Vendors: see list3
Clinical Trials: see list884
Patent Applications: see list268
Therapeutic Class:Antibacterials
Drug Prices:see low prices
DailyMed Link:amoxicillin; clavulanate potassium at DailyMed

Pharmacology for Ingredient: amoxicillin; clavulanate potassium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz Inc
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
TABLET;ORAL065093-001Nov 21, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
TABLET, EXTENDED RELEASE;ORAL090227-001Apr 21, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
TABLET;ORAL065102-001Sep 17, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Sandoz
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
TABLET, CHEWABLE;ORAL065065-001Apr 18, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Sandoz
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
TABLET;ORAL065064-001Mar 15, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: amoxicillin; clavulanate potassium

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
6,294,199 Method of treating a bacterial infection comprising administering amoxycillin► Subscribe
6,660,299 Modified release pharmaceutical formulation comprising amoxycillin► 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: amoxicillin; clavulanate potassium

Country Document Number Estimated Expiration
Eurasian Patent Organization004310► Subscribe
France2792198► Subscribe
China1373664► Subscribe
New Zealand523993► Subscribe
Turkey200102962► 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:

Fuji
Chubb
Chinese Patent Office
McKesson
Teva
Covington
Boehringer Ingelheim
McKinsey
UBS
Citi

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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