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Last Updated: August 9, 2020

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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 freedom to operate?

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 fifteen 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-nine 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

Sihuan Pharmaceutical Holdings Group Ltd.Phase 1
IRCCS Burlo GarofoloPhase 4
Saskatchewan Health Authority - Regina AreaN/A

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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
Aurobindo Pharma Ltd AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 201091-001 Dec 20, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Apothecon TRIMOX amoxicillin CAPSULE;ORAL 061885-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz AMOXICILLIN amoxicillin TABLET;ORAL 065228-002 Jul 13, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Cumberland Pharms OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN amoxicillin; clarithromycin; omeprazole CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL 050824-001 Feb 8, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
Aurobindo AMOXICILLIN amoxicillin CAPSULE;ORAL 065271-002 Nov 9, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Belcher Pharms AMOXICILLIN amoxicillin CAPSULE;ORAL 062058-002 Approved Prior to Jan 1, 1982 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

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