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Last Updated: March 28, 2024

CAPECITABINE - Generic Drug Details


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What are the generic drug sources for capecitabine and what is the scope of freedom to operate?

Capecitabine is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Dr Reddys, Eugia Pharma, Hikma, MSN, Reliance Life, Rising, Shilpa, Sun Pharm, Teva Pharms Usa, Teyro Labs, and Cheplapharm, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

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

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
Teyro Labs CAPECITABINE capecitabine TABLET;ORAL 217237-002 Oct 23, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cheplapharm XELODA capecitabine TABLET;ORAL 020896-002 Apr 30, 1998 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Shilpa CAPECITABINE capecitabine TABLET;ORAL 207456-002 Dec 12, 2016 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

Expired US Patents for CAPECITABINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cheplapharm XELODA capecitabine TABLET;ORAL 020896-001 Apr 30, 1998 ⤷  Try a Trial ⤷  Try a Trial
Cheplapharm XELODA capecitabine TABLET;ORAL 020896-001 Apr 30, 1998 ⤷  Try a Trial ⤷  Try a Trial
Cheplapharm XELODA capecitabine TABLET;ORAL 020896-002 Apr 30, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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