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Last Updated: April 22, 2024

Amoxicillin - Generic Drug Details


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What are the generic sources for amoxicillin and what is the scope of patent protection?

Amoxicillin is the generic ingredient in twenty-five branded drugs marketed by Aurobindo, Chartwell, Hikma Pharms, Labs Atral, Micro Labs, Mylan, Sandoz, Strides Pharma, Sun Pharm Inds Ltd, Teva, Glaxosmithkline, Us Antibiotics, Apothecon, Parke Davis, Wyeth Ayerst, Aurobindo Pharma Ltd, Chartwell Rx, Dava Pharms Inc, Hikma, Wockhardt Bio Ag, Pragma, Ranbaxy Labs Ltd, Ani Pharms, Rising, Takeda Pharms Usa, Cumberland, Phathom, Aurobindo Pharma, Deva Holding As, Micro Labs Ltd India, Sandoz Inc, Apotex Inc, Teva Pharms Usa, and Redhill, and is included in one hundred and twenty-six NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amoxicillin has eleven patent family members in six countries.

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

Drug Prices for amoxicillin

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Drug Sales Revenue Trends for amoxicillin

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Recent Clinical Trials for amoxicillin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Missouri-ColumbiaPhase 4
Abdul El-RabbanyPhase 4
TenNor Therapeutics (Suzhou) LimitedPhase 3

See all amoxicillin clinical trials

Pharmacology for amoxicillin
Medical Subject Heading (MeSH) Categories for amoxicillin

US Patents and Regulatory Information for amoxicillin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Us Antibiotics AUGMENTIN '250' amoxicillin; clavulanate potassium TABLET;ORAL 050564-001 Aug 6, 1984 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Us Antibiotics AMOXIL amoxicillin FOR SUSPENSION;ORAL 050760-001 Apr 15, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx AMOXICILLIN amoxicillin TABLET;ORAL 065344-001 Jan 15, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Us Antibiotics AMOXIL amoxicillin TABLET;ORAL 050754-001 Jul 10, 1998 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apothecon AMOXICILLIN amoxicillin TABLET, CHEWABLE;ORAL 064131-002 May 6, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for amoxicillin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pragma MOXATAG amoxicillin TABLET, EXTENDED RELEASE;ORAL 050813-001 Jan 23, 2008 ⤷  Try a Trial ⤷  Try a Trial
Pragma MOXATAG amoxicillin TABLET, EXTENDED RELEASE;ORAL 050813-001 Jan 23, 2008 ⤷  Try a Trial ⤷  Try a Trial
Pragma MOXATAG amoxicillin TABLET, EXTENDED RELEASE;ORAL 050813-001 Jan 23, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for amoxicillin

Country Patent Number Title Estimated Expiration
European Patent Office 1968586 COMPOSITIONS PHARMACEUTIQUES ET MÉTHODES POUR ÉRADICATION BACTÉRIENNE AMÉLIORÉE (PHARMACEUTICAL COMPOSITIONS AND METHODS FOR IMPROVED BACTERIAL ERADICATION) ⤷  Try a Trial
Japan 5788142 ⤷  Try a Trial
Australia 2006321782 Pharmaceutical compositions and methods for improved bacterial eradication ⤷  Try a Trial
Canada 2635378 COMPOSITIONS PHARMACEUTIQUES ET METHODES POUR ERADICATION BACTERIENNE AMELIOREE (PHARMACEUTICAL COMPOSITIONS AND METHODS FOR IMPROVED BACTERIAL ERADICATION) ⤷  Try a Trial
European Patent Office 1969134 PRODUITS D'AMOXICILLINE À LIBÉRATION MODIFIÉE (MODIFIED RELEASE AMOXICILLIN PRODUCTS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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