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Last Updated: November 22, 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, Hetero Labs Ltd V, Hikma, MSN, Reliance Life, Rising, Shilpa, Sun Pharm, Teva Pharms Usa, Teyro Labs, and Cheplapharm, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for CAPECITABINE
Drug Prices for CAPECITABINE

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Recent Clinical Trials for CAPECITABINE

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

SponsorPhase
Dartmouth-Hitchcock Medical CenterPhase 1/Phase 2
Lee Ocuin, MDPhase 2
Henry Ford Health SystemPhase 1

See all CAPECITABINE clinical trials

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
Hetero Labs Ltd V CAPECITABINE capecitabine TABLET;ORAL 210203-001 Mar 5, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cheplapharm XELODA capecitabine TABLET;ORAL 020896-001 Apr 30, 1998 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teyro Labs CAPECITABINE capecitabine TABLET;ORAL 217237-002 Oct 23, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teyro Labs CAPECITABINE capecitabine TABLET;ORAL 217237-001 Oct 23, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Reliance Life CAPECITABINE capecitabine TABLET;ORAL 211724-001 Apr 27, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Cheplapharm XELODA capecitabine TABLET;ORAL 020896-002 Apr 30, 1998 ⤷  Sign Up ⤷  Sign Up
Cheplapharm XELODA capecitabine TABLET;ORAL 020896-002 Apr 30, 1998 ⤷  Sign Up ⤷  Sign Up
Cheplapharm XELODA capecitabine TABLET;ORAL 020896-001 Apr 30, 1998 ⤷  Sign Up ⤷  Sign Up
>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
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
Krka, d.d., Novo mesto Ecansya (previously Capecitabine Krka) capecitabine EMEA/H/C/002605
Ecansya is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.Ecansya is indicated for the treatment of metastatic colorectal cancer.Ecansya is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.Ecansya 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. Ecansya 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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