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Generated: July 19, 2018

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GEMCITABINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for gemcitabine hydrochloride and what is the scope of gemcitabine hydrochloride freedom to operate?

Gemcitabine hydrochloride
is the generic ingredient in two branded drugs 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 Pharms Inc, Mylan Labs Ltd, Sagent Pharms, Sun Pharma Global, Teva Pharms, and Lilly, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for gemcitabine hydrochloride. Seventeen suppliers are listed for this compound.
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
Dr Reddys Labs Ltd GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 091365-001 Jul 25, 2011 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hospira Inc GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 200795-002 Aug 4, 2011 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Fresenius Kabi Oncol GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 090799-002 Jul 25, 2011 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Totowa GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 079160-001 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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Expired US Patents for GEMCITABINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-002 May 15, 1996 ➤ Sign Up ➤ Sign Up
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996 ➤ Sign Up ➤ Sign Up
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996 ➤ Sign Up ➤ Sign Up
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-002 May 15, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Chubb
Teva
Cerilliant
Chinese Patent Office
Fish and Richardson
Julphar
McKesson
McKinsey

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