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Amoxicillin; clavulanate potassium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for amoxicillin; clavulanate potassium?

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-two patent family members in forty-seven countries.

There are forty-three 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 list43
Suppliers / Packagers: see list46
Bulk Api Vendors: see list3
Clinical Trials: see list356
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
TABLET;ORAL065063-001Mar 14, 2002RXNoNo► Subscribe► Subscribe
Sandoz Inc
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL065358-001Aug 13, 2007RXNoNo► Subscribe► Subscribe
Aurobindo Pharma Ltd
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL201090-001Dec 20, 2011RXNoNo► Subscribe► Subscribe
Sun Pharm Inds Ltd
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
TABLET, CHEWABLE;ORAL065161-002Dec 3, 2003DISCNNoNo► Subscribe► Subscribe
Sun Pharm Inds Ltd
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL065132-001Mar 19, 2003DISCNNoNo► 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
Germany60003255► Subscribe
Czech Republic20013676► Subscribe
Portugal102450► Subscribe
Netherlands1014914► Subscribe
United Kingdom0122638► 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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