XELODA Drug Patent Profile
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Which patents cover Xeloda, and what generic alternatives are available?
Xeloda is a drug marketed by Cheplapharm and is included in one NDA.
The generic ingredient in XELODA 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 Xeloda
A generic version of XELODA was approved as capecitabine by TEVA PHARMS USA on September 16th, 2013.
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Summary for XELODA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 119 |
Clinical Trials: | 631 |
Drug Prices: | Drug price information for XELODA |
What excipients (inactive ingredients) are in XELODA? | XELODA excipients list |
DailyMed Link: | XELODA at DailyMed |
Recent Clinical Trials for XELODA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dartmouth-Hitchcock Medical Center | Phase 1/Phase 2 |
Gilead Sciences | Phase 1 |
University of Alabama at Birmingham | Phase 2 |
Pharmacology for XELODA
Drug Class | Nucleoside Metabolic Inhibitor |
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Paragraph IV (Patent) Challenges for XELODA
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 XELODA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cheplapharm | XELODA | capecitabine | TABLET;ORAL | 020896-001 | Apr 30, 1998 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cheplapharm | XELODA | capecitabine | TABLET;ORAL | 020896-002 | Apr 30, 1998 | AB | RX | Yes | Yes | ⤷ 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 XELODA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 |
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 XELODA
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 |
International Patents for XELODA
See the table below for patents covering XELODA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Greece | 3020286 | ⤷ Sign Up | |
Denmark | 640388 | ⤷ Sign Up | |
Algeria | 1270 | Dérivés de fluorocytidine. | ⤷ Sign Up |
Japan | H0678350 | ⤷ Sign Up | |
Latvia | 5624 | Panemiens 5'-dezoksi-5-fluorcitidina atvasinajumu iegusanai | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XELODA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0316704 | C300045 | Netherlands | ⤷ Sign Up | PRODUCT NAME: CAPECITABINE,DESGEWENST IN DE VORM VAN EEN SOLVAAT; NATL REGISTRATION NO/DATE: EU/1/00/163/001-002 20010202; FIRST REGISTRATION: CH 54657 19980610 |
0316704 | 2001C/021 | Belgium | ⤷ Sign Up | PRODUCT NAME: CAPECITABINE, NATL REGISTRATION NO/DATE: EU/1/00/163/001 20010205; FIRST REGISTRATION: CH 54657 19980610 |
0316704 | SPC/GB01/015 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: CAPECITABINE AND HYDRATES AND SOLVATES THEREOF; REGISTERED: CH 54657 19980610; UK EU/1/00/163/001-002 20010202 |
0316704 | 14/2001 | Austria | ⤷ Sign Up | PRODUCT NAME: CAPECITABIN; NAT. REGISTRATION NO/DATE: - 20010202; FIRST REGISTRATION: EU EU/1/00/163/001, EU/1/00/163/002 20010202 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |