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Last Updated: August 13, 2020

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When do Capecitabine patents expire, and what generic alternatives are available?

Capecitabine is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Eugia Pharma, Hikma, MSN, Mylan, Reliance Life, Shilpa Medicare Ltd, Sun Pharm, and Teva Pharms Usa. and is included in eleven NDAs.

The generic ingredient in CAPECITABINE is capecitabine. There are twenty-eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the capecitabine profile page.

US ANDA Litigation and Generic Entry Outlook for Capecitabine

A generic version of CAPECITABINE was approved as capecitabine by TEVA PHARMS USA on September 16th, 2013.

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Drug patent expirations by year for CAPECITABINE
Drug Prices for CAPECITABINE

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Recent Clinical Trials for CAPECITABINE

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

MedSIRPhase 2
ExelixisPhase 2
University of PennsylvaniaPhase 2

See all CAPECITABINE clinical trials

Pharmacology for CAPECITABINE
Medical Subject Heading (MeSH) Categories for CAPECITABINE
Paragraph IV (Patent) Challenges for CAPECITABINE
Tradename Dosage Ingredient NDA Submissiondate
XELODA TABLET;ORAL capecitabine 020896 2008-11-10

US Patents and Regulatory Information for CAPECITABINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare CAPECITABINE capecitabine TABLET;ORAL 202593-001 Apr 23, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Shilpa Medicare Ltd CAPECITABINE capecitabine TABLET;ORAL 207456-002 Dec 12, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Eugia Pharma CAPECITABINE capecitabine TABLET;ORAL 210604-001 Apr 17, 2018 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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