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Last Updated: August 9, 2020

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Capecitabine - Generic Drug Details

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

Capecitabine is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Eugia Pharma, Hikma, MSN, Mylan, Reliance Life, Shilpa Medicare Ltd, Sun Pharm, Teva Pharms Usa, and Hoffmann La Roche, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for capecitabine. Eighteen suppliers are listed for this compound.

Drug Prices for capecitabine

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Recent Clinical Trials for capecitabine

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

SponsorPhase
ExelixisPhase 2
MedSIRPhase 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 202593-002 Apr 23, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Alkem Labs Ltd CAPECITABINE capecitabine TABLET;ORAL 207652-002 Nov 24, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa CAPECITABINE capecitabine TABLET;ORAL 091649-001 Sep 16, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm CAPECITABINE capecitabine TABLET;ORAL 204668-001 Jun 21, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan CAPECITABINE capecitabine TABLET;ORAL 090943-001 Aug 8, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-002 Apr 30, 1998 AB RX Yes Yes   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

Expired US Patents for capecitabine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-001 Apr 30, 1998   Start Trial   Start Trial
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-002 Apr 30, 1998   Start Trial   Start Trial
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-002 Apr 30, 1998   Start Trial   Start Trial
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-001 Apr 30, 1998   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:

McKinsey
Baxter
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Colorcon
Express Scripts
Merck

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