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Last Updated: January 20, 2020

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CAPECITABINE Drug Profile

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Which patents cover Capecitabine, and what generic alternatives are available?

Capecitabine is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Eugia Pharma, Hikma, Msn Labs Pvt Ltd, Mylan, Shilpa Medicare Ltd, Sun Pharm, and Teva Pharms Usa. and is included in ten NDAs.

The generic ingredient in CAPECITABINE is capecitabine. There are twenty-eight drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the capecitabine profile page.

US ANDA Litigation and Generic Entry Outlook for Capecitabine

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A generic version of CAPECITABINE was approved as capecitabine by TEVA PHARMS USA on January 20th, 2020.

Drug patent expirations by year for CAPECITABINE
Drug Prices for CAPECITABINE

See drug prices for CAPECITABINE

Recent Clinical Trials for CAPECITABINE

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

SponsorPhase
Shanghai Zhongshan HospitalPhase 1
The fifth medical center of PLA general hospitalPhase 2
CSPC Ouyi Pharmaceutical Co., Ltd.Phase 2

See all CAPECITABINE clinical trials

Recent Litigation for CAPECITABINE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Hoffmann-La Roche Inc. v. Teva Pharmaceuticals USA, Inc.2012-01-03
HOFFMANN-LA ROCHE INC. v. MYLAN INC.2011-06-07
HOFFMANN-LA ROCHE INC. v. TEVA PHARMACEUTICALS USA, INC.2009-10-16

See all CAPECITABINE litigation

Pharmacology for CAPECITABINE
Medical Subject Heading (MeSH) Categories for CAPECITABINE
Synonyms for CAPECITABINE
(1-(5-Deoxy-beta-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinyl)-carbamic acid pentyl ester
154361-50-9
158798-73-3
361C509
5'-Deoxy-5-fluoro-N-((pentyloxy)carbonyl)cytidine
5'-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine
5'-deoxy-5-fluoro-N4-(pentyloxycarbonyl)cytidine
6804DJ8Z9U
958887-39-3
AB0068959
AB01274776_04
AB01274776-01
AB01274776-02
AC1L1U83
AC1Q4KU8
AJ-45659
AK-72933
AKOS015920130
AM84502
AMX10125
AN-16068
BC215614
BCP9000483
BCPP000300
BR-72933
BRD-K61192372-001-08-9
BS-1000
C-20872
C12650
C15H22FN3O6
Capecitabin
capecitabina
Capecitabine (JAN/USAN/INN)
Capecitabine (Xeloda)
Capecitabine [USAN:USP:INN:BAN]
Capecitabine [USAN]
Capecitabine, >=98% (HPLC)
Capecitabine, 99%
Capecitabine, analytical standard
Capecitabine, European Pharmacopoeia (EP) Reference Standard
Capecitabine, Pharmaceutical Secondary Standard; Certified Reference Material
Capecitabine, United States Pharmacopeia (USP) Reference Standard
capecitabinum
Capecitibine
Capiibine
Captabin
Carbamic acid, (1-(5-deoxy-beta-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinyl)-, pentyl ester
CAS-154361-50-9
Caxeta
CC-25374
CC0143
CHEBI:31348
CHEMBL1773
CS-0768
CTK0H6126
CYT011
Cytidine, 5'-deoxy-5-fluoro-N-((pentyloxy)carbonyl)-
Cytidine, 5'-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]-
D01223
DB01101
DSSTox_CID_26451
DSSTox_GSID_46451
DSSTox_RID_81625
DTXSID3046451
EX-A835
FT-0082472
FT-0601618
FT-0696497
GAGWJHPBXLXJQN-UORFTKCHSA-N
GTPL6799
HSDB 7656
HY-B0016
J-700154
KS-00000E7O
LS-59070
MCULE-2851259722
MLS003915642
MLS004774137
MolPort-005-938-254
N(4)-Pentyloxycarbonyl-5'-deoxy-5-fluorocytidine
n4-pentyloxycarbonyl-5'-deoxy-5-fluorocytidine
NCGC00164569-01
NCGC00164569-02
Pentyl (1-((2R,3R,4S,5R)-3,4-dihydroxy-5-methyltetrahydrofuran-2-yl)-5-fluoro-2-oxo-1,2-dihydropyrim
Pentyl (1-((2R,3R,4S,5R)-3,4-dihydroxy-5-methyltetrahydrofuran-2-yl)-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl)carbamate
Pentyl [1-(5-deoxy-beta-D-ribofuranosyl)-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]carbamate
pentyl 1-((2R,3R,4S,5R)-3,4-dihydroxy-5-methyltetrahydrofuran-2-yl)-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-ylcarbamate
Pentyl 1-(5-deoxy-beta-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinecarbamate
pentyl N-[1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-methyl-tetrahydrofuran-2-yl]-5-fluoro-2-oxo-pyrimidin-4-yl]carbamate
pentyl N-[1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-methyloxolan-2-yl]-5-fluoro-2-oxopyrimidin-4-yl]carbamate
pentyl N-{1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-methyloxolan-2-yl]-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl}carbamate
PubChem21443
Q-200788
R-340
R340
RG-340
Ro 09-1978
Ro 09-1978/000
Ro-09-1978
Ro-09-1978-000
Ro-091978000
S-3173
s1156
SC-08810
SCHEMBL8153
SMR002530052
SR-01000931255
SR-01000931255-3
ST2413659
Tox21_112198
Tox21_112198_1
UNII-6804DJ8Z9U
Xabine
Xeloda
Xeloda (TN)
Z1741971721
ZINC3806413
Paragraph IV (Patent) Challenges for CAPECITABINE
Tradename Dosage Ingredient NDA Submissiondate
XELODA TABLET;ORAL capecitabine 020896 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
Accord Hlthcare CAPECITABINE capecitabine TABLET;ORAL 202593-001 Apr 23, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm CAPECITABINE capecitabine TABLET;ORAL 204668-002 Jun 21, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Eugia Pharma CAPECITABINE capecitabine TABLET;ORAL 210604-001 Apr 17, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Alkem Labs Ltd CAPECITABINE capecitabine TABLET;ORAL 207652-002 Nov 24, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Moodys

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