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Last Updated: March 4, 2021

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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-three branded drugs marketed by Aurobindo, Belcher Pharms, Dava Pharms Inc, Hikma Pharms, Labs Atral, Mylan, Sandoz, Sun Pharm Inds Ltd, Teva, Glaxosmithkline, Neopharma, Apothecon, Parke Davis, Wyeth Ayerst, Aurobindo Pharma Ltd, Hikma, Wockhardt Bio Ag, Pragma, Ranbaxy Labs Ltd, Ani Pharms Inc, Rising, Sandoz Inc, Takeda Pharms Usa, Cumberland Pharms, Apotex Inc, Micro Labs Ltd India, Teva Pharms Usa, and Redhill, and is included in one hundred and sixteen NDAs. There are fifteen 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-six drug master file entries for amoxicillin. Twenty-seven 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 LausannePhase 4
Poitiers University HospitalPhase 3
Iqvia Pty LtdPhase 4

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
Hikma AMOXICILLIN amoxicillin TABLET, CHEWABLE;ORAL 205274-001 Jun 25, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd AMOXICILLIN amoxicillin TABLET, FOR SUSPENSION;ORAL 065324-002 Jan 17, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 065066-001 Jun 5, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Neopharma AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785-001 Sep 25, 2002 DISCN Yes No   Start Trial   Start Trial Y   Start 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   Start Trial   Start Trial
Pragma MOXATAG amoxicillin TABLET, EXTENDED RELEASE;ORAL 050813-001 Jan 23, 2008   Start Trial   Start Trial
Pragma MOXATAG amoxicillin TABLET, EXTENDED RELEASE;ORAL 050813-001 Jan 23, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
McKinsey
Medtronic
Harvard Business School
Boehringer Ingelheim

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