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Amoxicillin - Generic Drug Details

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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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-seven patent family members in six countries.

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

Summary for Generic Name: amoxicillin

Tradenames:22
Patents:11
Applicants:27
NDAs:113
Drug Master File Entries: see list43
Suppliers / Packagers: see list55
Bulk Api Vendors: see list36
Clinical Trials: see list120
Patent Applications: see list6,270
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wockhardt Eu Operatn
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL065420-001Dec 2, 2013RXNoNo► subscribe► subscribe
Dr Reddys Labs Inc
AUGMENTIN '200'
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL050725-001May 31, 1996RXNoNo► subscribe► subscribe
Am Antibiotics
AMOXICILLIN
amoxicillin
CAPSULE;ORAL062058-001Approved Prior to Jan 1, 1982RXNoNo► 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
6,541,014 Antiviral product, use and formulation thereof► subscribe
7,025,989Multiple-delayed released antibiotic product, use and formulation thereof► subscribe
8,889,187Once a day amoxicillin product comprising immediate and delayed release dosage forms► 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
European Patent Office1465591► subscribe
Australia2006321782► subscribe
Canada2494017► 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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