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Generated: November 17, 2018

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Gemcitabine hydrochloride - Generic Drug Details

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

Gemcitabine hydrochloride is the generic ingredient in three 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, Mylan Labs Ltd, Sagent Pharms, Sun Pharma Global, Teva Pharms, Lilly, and Sun Pharm Inds Ltd, and is included in twenty-six NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for gemcitabine hydrochloride. Eighteen 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
Actavis Totowa GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 079160-001 Jul 25, 2011 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sagent Pharms GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 209077-003 Jul 20, 2018 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sun Pharma Global GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 078433-001 Jul 25, 2011 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sagent Pharms GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 091597-002 May 7, 2013 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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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 ➤ Try a Free Trial ➤ Try a Free Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-002 May 15, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for gemcitabine hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0030 Belgium ➤ Try a Free Trial PRODUCT NAME: CHLORHYDRATE DE GEMCITABINE EQUIVALENT EN GEMCITABINE; NAT. REGISTRATION NO/DATE: 58 IS 88 F 12 19960606; FIRST REGISTRATION: NL RVG 17854 19950327
C/GB95/031 United Kingdom ➤ Try a Free Trial PRODUCT NAME: GEMCITABINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY- ACCEPTABLE SALT; REGISTERED: NL RVG17854 19950327; UK 00006/0301 19951026; UK 00006/0302 19951026
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Johnson and Johnson
Colorcon
Teva
Julphar
Medtronic
Fuji
Boehringer Ingelheim
Daiichi Sankyo

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