.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

► See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

AstraZeneca
McKesson
Merck
Covington
Citi
Deloitte
Colorcon
Argus Health
Dow
Accenture

Generated: September 19, 2017

DrugPatentWatch Database Preview

Amoxicillin - Generic Drug Details

« Back to Dashboard

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 eleven 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:11
Applicants:27
NDAs:113
Drug Master File Entries: see list44
Suppliers / Packagers: see list56
Bulk Api Vendors: see list36
Clinical Trials: see list319
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
Sandoz
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
TABLET;ORAL065064-001Mar 15, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Inc
AMOXIL
amoxicillin
FOR SUSPENSION;ORAL062226-001Approved Prior to Jan 1, 1982ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Inc
AUGMENTIN '250'
amoxicillin; clavulanate potassium
TABLET, CHEWABLE;ORAL050597-002Jul 22, 1985DISCNYesNo► Subscribe► Subscribe► Subscribe
Sandoz
AMOXICILLIN
amoxicillin
FOR SUSPENSION;ORAL065378-002Mar 26, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Vernalis R And D Ltd
MOXATAG
amoxicillin
TABLET, EXTENDED RELEASE;ORAL050813-001Jan 23, 2008RXYesYes► Subscribe► SubscribeYY ► Subscribe
Takeda Pharms Usa
PREVPAC
amoxicillin; clarithromycin; lansoprazole
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL050757-001Dec 2, 1997ABRXYesYes► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Inc
LAROTID
amoxicillin
FOR SUSPENSION;ORAL062226-003Approved Prior to Jan 1, 1982ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva
AMOXICILLIN
amoxicillin
FOR SUSPENSION;ORAL065119-001Dec 4, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Apothecon
TRIMOX
amoxicillin
FOR SUSPENSION;ORAL062099-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Inc
AMOXIL
amoxicillin
TABLET, CHEWABLE;ORAL050761-002Apr 15, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
7,108,859Antineoplastic product, use and formulation thereof► Subscribe
7,157,095Multiple-delayed release antifungal product, use and formulation thereof► Subscribe
6,541,014 Antiviral product, use and formulation thereof► Subscribe
6,667,057 Levofloxacin antibiotic product, use and formulation thereof► Subscribe
6,667,042 Fluroquinilone antibiotic product, use and formulation thereof► Subscribe
7,282,221Antiviral product, use and formulation thereof► Subscribe
6,663,891 Erythromyacin antibiotic product, use and formulation thereof► Subscribe
8,889,187Once a day amoxicillin product comprising immediate and delayed release dosage forms► Subscribe
7,105,174Multiple-delayed release anti-neoplastic product, use and formulation thereof► Subscribe
7,025,989Multiple-delayed released antibiotic product, use and formulation thereof► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: amoxicillin

Country Document Number Estimated Expiration
Japan5788142► Subscribe
Canada2494015► Subscribe
Australia2003257176► Subscribe
Japan2003523378► Subscribe
European Patent Office1465591► Subscribe
World Intellectual Property Organization (WIPO)2004012509► Subscribe
European Patent Office1969134► Subscribe
European Patent Office1257255► Subscribe
Japan2012001528► Subscribe
European Patent Office1545465► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Deloitte
Federal Trade Commission
US Army
McKinsey
Cantor Fitzgerald
Queensland Health
Accenture
McKesson
Colorcon

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot