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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Queensland Health
Daiichi Sankyo
Mallinckrodt
Johnson and Johnson
Merck
Moodys
UBS
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Generated: July 25, 2017

DrugPatentWatch Database Preview

Amoxicillin - Generic Drug Details

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What are the generic sources for amoxicillin and what is the scope of amoxicillin freedom to operate?

Amoxicillin
is the generic ingredient in twenty-two branded drugs marketed by Teva, Parke Davis, Sun Pharm Inds Ltd, Vernalis R And D Ltd, Dr Reddys Labs Inc, Wockhardt, Wyeth Ayerst, Hikma, Apothecon, Aurobindo Pharma Ltd, Dava Pharms Inc, Labs Atral, Sandoz, Aurobindo, Am Antibiotics, Glaxosmithkline, Ranbaxy Labs Ltd, Mylan, Hikma Pharms, Rising Pharms Inc, Teva Pharms Usa, Takeda Pharms Usa, Sandoz Inc, Gastroentero, Micro Labs Ltd India, Apotex Inc, and Wockhardt Eu Operatn, and is included in one hundred and thirteen NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amoxicillin has thirty-seven patent family members in six countries.

There are forty-four drug master file entries for amoxicillin. Fifty-six suppliers are listed for this compound.

Summary for Generic Name: amoxicillin

Tradenames:22
Patents:12
Applicants:27
NDAs:113
Drug Master File Entries: see list44
Suppliers / Packagers: see list56
Bulk Api Vendors: see list36
Clinical Trials: see list316
Patent Applications: see list7,153
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:amoxicillin at DailyMed

Pharmacology for Ingredient: amoxicillin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apothecon
TRIMOX
amoxicillin
CAPSULE;ORAL062152-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Apothecon
AMOXICILLIN
amoxicillin
TABLET, CHEWABLE;ORAL064131-001May 6, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
Am Antibiotics
AMOXICILLIN
amoxicillin
FOR SUSPENSION;ORAL062059-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Teva
AMOXICILLIN
amoxicillin
FOR SUSPENSION;ORAL065119-001Dec 4, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Parke Davis
UTIMOX
amoxicillin
CAPSULE;ORAL062107-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: amoxicillin

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
6,730,320 Tetracycline antibiotic product, use and formulation thereof► Subscribe
7,282,221Antiviral product, use and formulation thereof► Subscribe
7,108,859Antineoplastic product, use and formulation thereof► Subscribe
6,541,014 Antiviral product, use and formulation thereof► Subscribe
8,303,988Antifungal once-a-day product, use and formulation 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: amoxicillin

Country Document Number Estimated Expiration
Australia2003257176► Subscribe
World Intellectual Property Organization (WIPO)2004012713► Subscribe
European Patent Office1969134► Subscribe
Japan2005538121► Subscribe
Japan2012001528► 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:

Boehringer Ingelheim
McKinsey
Federal Trade Commission
Cerilliant
Daiichi Sankyo
Citi
Covington
Teva
Cantor Fitzgerald
Chinese Patent Office

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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