XELODA Drug Patent Profile

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-four 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 16^th, 2013.

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

See drug prices for XELODA

Recent Clinical Trials for XELODA

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

Sponsor	Phase
Dartmouth-Hitchcock Medical Center	Phase 1/Phase 2
University of Alabama at Birmingham	Phase 2
Henry Ford Health System	Phase 1

See all XELODA clinical trials

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
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-002	Apr 30, 1998	AB	RX	Yes	Yes

Expired US Patents for XELODA

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

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

International Patents for XELODA

See the table below for patents covering XELODA around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	9303525
Japan	2501297
Georgia, Republic of	P20074251	N-OXYCARBONYL SUBSTITUTED 5'- DEOXY-5-FLUOROCYTIDINES
Russian Federation	2493162	N-ОКСИКАРБОНИЛЗАМЕЩЕННЫЕ 5'-ДЕОКСИ-5-ФТОРЦИТИДИНЫ И ФАРМАЦЕВТИЧЕСКИЙ ПРЕПАРАТ (N-OXYCARBONYL-SUBSTITUTED 5'-DEOXY-5-FLUOROCYTIDINES AND PHARMACEUTICAL PREPARATION)

Supplementary Protection Certificates for XELODA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0316704	14/2001	Austria		PRODUCT NAME: CAPECITABIN; NAT. REGISTRATION NO/DATE: - 20010202; FIRST REGISTRATION: EU EU/1/00/163/001, EU/1/00/163/002 20010202
0316704	C300045	Netherlands		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		PRODUCT NAME: CAPECITABINE, NATL REGISTRATION NO/DATE: EU/1/00/163/001 20010205; FIRST REGISTRATION: CH 54657 19980610
0316704	SPC/GB01/015	United Kingdom		PRODUCT NAME: CAPECITABINE AND HYDRATES AND SOLVATES THEREOF; REGISTERED: CH 54657 19980610; UK EU/1/00/163/001-002 20010202