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Generated: October 19, 2018

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GEMCITABINE HYDROCHLORIDE Drug Profile

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When do Gemcitabine Hydrochloride patents expire, and when can generic versions of Gemcitabine Hydrochloride launch?

Gemcitabine Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Inc, Actavis Totowa, Apotex Inc, Cipla Ltd, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Oncol, Fresenius Kabi Usa, Gland Pharma Ltd, Hameln Rds Gmbh, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Luitpold, Mylan Labs Ltd, Sagent Pharms, Sun Pharma Global, and Teva Pharms. and is included in twenty-four NDAs.

The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There are twenty-nine drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.

Drug patent expirations by year for GEMCITABINE HYDROCHLORIDE
Pharmacology for GEMCITABINE HYDROCHLORIDE
Synonyms for GEMCITABINE HYDROCHLORIDE
(+)-2'-Deoxy-2',2'-difluorocytidine hydrochloride
(2'R,4'R,5'R)-4-Amino-1-(3,3-difluoro-4-hydroxy-5-hydroxymethyl-tetrahydro-furan-2-yl)-1H-pyridin-2-one hydrochloride
111G039
12211-03-9
122111-03-9
139306-EP2270008A1
139306-EP2289892A1
139306-EP2292617A1
2'-Deoxy-2',2'-difluorocytidine
2'-deoxy-2',2'-difluorocytidine hydrochloride
2'-Deoxy-2',2'-difluorocytidine monohydrochloride
2'-Deoxy-2',2'-difluorocytidine monohydrochloride (beta-isomer)
2'-deoxy-2',2'-difluorocytidine, hydrochloride
2',2'-difluoro-2'-deoxycytidine
2',2'-DIFLUORO-2'-DEOXYCYTIDINE HCL
2',2'-Difluoro-2'-deoxycytidine hydrochloride
2',2'-Difluorodeoxycytidine monohydrochloride
4-amino-1-(3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidin-2(1H)-one hydrochloride
4-amino-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one hydrochloride
4-amino-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one;hydrochloride
4-amino-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]pyrimidin-2-one hydrochloride
4-Amino-1-[3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]-1H-pyrimidin-2-one hydrochloride
AB0069148
AC1L1TUN
ACN-029559
ACT06731
AK-94770
AKOS015999730
Ambap122111-03-9
AN-738
AOB6388
AS-13656
AX8040659
C9H11F2N3O4.HCl
CAS-122111-03-9
CC-28945
CHEBI:31647
CHEMBL1637
CPD000469146
CS-0755
Cytidine, 2'-deoxy-2',2'-difluoro-, hydrochloride (1:1)
Cytidine, 2'-deoxy-2',2'-difluoro-, monohydrochloride
D01155
DDFC
dFdC
Dizirconium silicide
DSSTox_CID_27827
DSSTox_GSID_47849
DSSTox_RID_82590
DTXSID3047849
EBD6307
EX-A837
FT-0626640
Gemcitabine (Hydrochloride)
Gemcitabine HCl
Gemcitabine HCl (Gemzar,LY188011)
Gemcitabine HCL (Gemzar)
Gemcitabine hydrochloride (JAN/USAN)
Gemcitabine hydrochloride [USAN:USP]
Gemcitabine hydrochloride [USAN]
Gemcitabine hydrochloride, >=98% (HPLC)
Gemcitabine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Gemcitabine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Gemcitabine Hydrochloride,Gemzar, LY-188011
Gemcitibine Hydrochloride
Gemzar
Gemzar (TN)
HY-B0003
Inno-D07001
J-700175
J10060
KS-000002I0
LS-59069
LY-188011
LY188011 hydrochloride
M-9023
MFCD01735988
MLS003915643
MolPort-003-824-457
NCGC00168784-01
NCGC00168784-03
OKKDEIYWILRZIA-OSZBKLCCSA-N
s1149
SAM001246550
SC-19019
SCHEMBL4366
SMR000469146
ST2413104
TL8000589
Tox21_112644
Tox21_112644_1
U347PV74IL
UNII-U347PV74IL
W-60402

US Patents and Regulatory Information for GEMCITABINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 205242-003 Dec 6, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hospira Inc GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 200795-003 Aug 4, 2011 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharma Global GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 078433-002 Jul 25, 2011 AP RX No No ➤ 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

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Express Scripts
Accenture
Citi
Federal Trade Commission
Julphar
Farmers Insurance
US Department of Justice
Fuji

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