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BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

McKinsey
Daiichi Sankyo
McKesson
Healthtrust
Mallinckrodt
Colorcon
Farmers Insurance
Accenture
Teva
Boehringer Ingelheim

Generated: November 17, 2017

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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 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-seven patent family members in forty-eight countries.

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

Summary for amoxicillin; clavulanate potassium

Pharmacology 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
Apotex Inc
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
TABLET;ORAL065317-003Oct 20, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Inc
AUGMENTIN XR
amoxicillin; clavulanate potassium
TABLET, EXTENDED RELEASE;ORAL050785-001Sep 25, 2002ABRXYesYes► Subscribe► Subscribe ► Subscribe
Teva
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL065089-002May 25, 2004ABRXNoYes► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Inc
AUGMENTIN XR
amoxicillin; clavulanate potassium
TABLET, EXTENDED RELEASE;ORAL050785-001Sep 25, 2002ABRXYesYes► Subscribe► Subscribe ► Subscribe
Dr Reddys Labs Inc
AUGMENTIN '250'
amoxicillin; clavulanate potassium
TABLET;ORAL050564-001Aug 6, 1984DISCNYesNo► Subscribe► Subscribe► Subscribe
Sandoz
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
TABLET;ORAL065064-001Mar 15, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL065132-001Mar 19, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
TABLET;ORAL091569-002Jan 20, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Inc
AUGMENTIN '250'
amoxicillin; clavulanate potassium
TABLET, CHEWABLE;ORAL050597-002Jul 22, 1985DISCNYesNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL065207-002Jan 30, 2007DISCNNoNo► 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
Czech Republic20013676► Subscribe
Australia5837500► Subscribe
Israel145581► Subscribe
Hungary229097► Subscribe
Norway20014960► Subscribe
Portugal1044680► Subscribe
New Zealand514575► Subscribe
New Zealand514574► Subscribe
Finland20000863► Subscribe
Finland4823► 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 leading biopharmaceutical companies globally:

McKinsey
Covington
US Army
McKesson
Daiichi Sankyo
Citi
Farmers Insurance
UBS
Federal Trade Commission
Argus Health

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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