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Last Updated: March 29, 2024

CAPECITABINE Drug Patent Profile


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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, Dr Reddys, Eugia Pharma, Hikma, MSN, Reliance Life, Rising, Shilpa, Sun Pharm, Teva Pharms Usa, and Teyro Labs. and is included in thirteen NDAs.

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

DrugPatentWatch® 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

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SponsorPhase
Chugai Pharmaceutical Co.Phase 1
University of CincinnatiPhase 2/Phase 3
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Phase 3

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Pharmacology for CAPECITABINE
Medical Subject Heading (MeSH) Categories for CAPECITABINE
Paragraph IV (Patent) Challenges for CAPECITABINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XELODA Tablets capecitabine 150 mg and 500 mg 020896 1 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising CAPECITABINE capecitabine TABLET;ORAL 090943-002 Aug 8, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa CAPECITABINE capecitabine TABLET;ORAL 091649-002 Sep 16, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys CAPECITABINE capecitabine TABLET;ORAL 204345-001 Dec 4, 2020 AB RX 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

EU/EMA Drug Approvals for CAPECITABINE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
medac Gesellschaft für klinische Spezialpräparate mbH Capecitabine Medac capecitabine EMEA/H/C/002568
Capecitabine Medac is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.Capecitabine Medac is indicated for the treatment of metastatic colorectal cancer.Capecitabine Medac is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.Capecitabine Medac in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Capecitabine Medac is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Authorised yes no no 2012-11-19
Accord Healthcare S.L.U. Capecitabine Accord capecitabine EMEA/H/C/002386
Capecitabine Accord is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.Capecitabine Accord is indicated for the treatment of metastatic colorectal cancer.Capecitabine Accord is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.Capecitabine Accord in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Capecitabine Accord is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Authorised yes no no 2012-04-20
Teva Pharma B.V. Capecitabine Teva capecitabine EMEA/H/C/002362
Capecitabine Teva is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer.Capecitabine Teva is indicated for the treatment of metastatic colorectal cancer.Capecitabine Teva is indicated for first‑line treatment of advanced gastric cancer in combination with a platinum‑based regimen.Capecitabine Teva in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine Teva is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Authorised yes no no 2012-04-20
CHEPLAPHARM Arzneimittel GmbH Xeloda capecitabine EMEA/H/C/000316
Xeloda is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer.Xeloda is indicated for the treatment of metastatic colorectal cancer.Xeloda is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.Xeloda in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Xeloda is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Authorised no no no 2001-02-02
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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