CAPECITABINE - Generic Drug Details

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-three suppliers are listed for this compound.

Summary for CAPECITABINE

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	15
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	1,785
Patent Applications:	7,051
Drug Prices:	Drug price trends for CAPECITABINE
What excipients (inactive ingredients) are in CAPECITABINE?	CAPECITABINE excipients list
DailyMed Link:	CAPECITABINE at DailyMed

See drug prices for CAPECITABINE

Recent Clinical Trials for CAPECITABINE

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

Sponsor	Phase
Dartmouth-Hitchcock Medical Center	Phase 1/Phase 2
Lee Ocuin, MD	Phase 2
Henry Ford Health System	Phase 1

See all CAPECITABINE clinical trials

Pharmacology for CAPECITABINE

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for CAPECITABINE

Antimetabolites, Antineoplastic

Anatomical Therapeutic Chemical (ATC) Classes for CAPECITABINE

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Hikma	CAPECITABINE	capecitabine	TABLET;ORAL	200483-002	Jul 14, 2016	AB	RX	No	No
Msn	CAPECITABINE	capecitabine	TABLET;ORAL	209365-002	Jul 2, 2018	AB	RX	No	No
Sun Pharm	CAPECITABINE	capecitabine	TABLET;ORAL	204668-001	Jun 21, 2019	AB	RX	No	No

Expired US Patents for CAPECITABINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-002	Apr 30, 1998
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-001	Apr 30, 1998
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-002	Apr 30, 1998

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