Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

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Capecitabine - Generic Drug Details

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What are the generic sources for capecitabine and what is the scope of patent protection?

Capecitabine is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Eugia Pharma, Msn Labs Pvt Ltd, Mylan, Shilpa Medicare Ltd, Sun Pharm, Teva Pharms Usa, West-ward Pharms Int, and Hoffmann La Roche, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

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

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
Mylan CAPECITABINE capecitabine TABLET;ORAL 090943-002 Aug 8, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa CAPECITABINE capecitabine TABLET;ORAL 091649-001 Sep 16, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa CAPECITABINE capecitabine TABLET;ORAL 091649-002 Sep 16, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Shilpa Medicare Ltd CAPECITABINE capecitabine TABLET;ORAL 207456-001 Dec 12, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int CAPECITABINE capecitabine TABLET;ORAL 200483-002 Jul 14, 2016 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

Expired US Patents for capecitabine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-001 Apr 30, 1998   Start Trial   Start Trial
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-002 Apr 30, 1998   Start Trial   Start Trial
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-002 Apr 30, 1998   Start Trial   Start Trial
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-001 Apr 30, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Express Scripts
McKinsey
Colorcon
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.