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Serving leading biopharmaceutical companies globally:

Novartis
Colorcon
McKinsey
QuintilesIMS
Harvard Business School
Moodys
US Department of Justice
Chubb
Healthtrust
Medtronic

Generated: January 20, 2018

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 Aurobindo Pharma Ltd, Hikma Pharms, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Teva, Wockhardt, Wockhardt Eu Operatn, Dr Reddys Labs Inc, Apotex Inc, Micro Labs Ltd India, and Teva Pharms Usa, and is included in forty-one NDAs. There are five 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-six patent family members in forty-eight countries.

There are forty-four drug master file entries for amoxicillin; clavulanate potassium. Fifty suppliers are listed for this compound.
Summary for amoxicillin; clavulanate potassium
Pharmacology for amoxicillin; clavulanate potassium

US Patents and Regulatory Information for 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
Dr Reddys Labs Inc AUGMENTIN '400' amoxicillin; clavulanate potassium TABLET, CHEWABLE;ORAL 050726-002 May 31, 1996 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apotex Inc AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 065333-001 Feb 24, 2009 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Micro Labs Ltd India AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 205707-002 Dec 30, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sandoz Inc AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 065098-002 Dec 16, 2002 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sandoz AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET, CHEWABLE;ORAL 065065-001 Apr 18, 2002 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Dr Reddys Labs Inc AUGMENTIN '875' amoxicillin; clavulanate potassium TABLET;ORAL 050720-001 Feb 13, 1996 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Dr Reddys Labs Inc AUGMENTIN '200' amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 050725-001 May 31, 1996 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Micro Labs Ltd India AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 205707-001 Dec 30, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sun Pharm Inds Ltd AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET, CHEWABLE;ORAL 065161-002 Dec 3, 2003 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sandoz AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 065066-002 Jun 5, 2002 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
Patent No. Title Estimated Patent Expiration

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International Patents for amoxicillin; clavulanate potassium

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Serving leading biopharmaceutical companies globally:

Chubb
Cerilliant
AstraZeneca
Mallinckrodt
Accenture
Citi
Federal Trade Commission
UBS
Healthtrust

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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