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Gemfibrozil - Generic Drug Details

What are the generic sources for gemfibrozil and what is the scope of gemfibrozil freedom to operate?
Gemfibrozil is the generic ingredient in two branded drugs marketed by Mylan, Purepac Pharm, Pfizer Pharms, Apotex, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Caribe Holdings, Chartwell Molecules, Hikma Pharms, Impax Pharms, Invagen Pharms, Northstar Hlthcare, Sun Pharm Inds Inc, Teva, Watson Labs, and Yaopharma Co Ltd, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

Fifty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for gemfibrozil

US Patents:	0
Tradenames:	2
Applicants:	16
NDAs:	19
Suppliers / Packagers:	50
Bulk Api Vendors:	82
Clinical Trials:	32
Patent Applications:	6,219
Formulation / Manufacturing:	see details
DailyMed Link:	gemfibrozil at DailyMed

Pharmacology for gemfibrozil

Ingredient-type	PPAR alpha
Drug Class	Peroxisome Proliferator Receptor alpha Agonist
Mechanism of Action	Peroxisome Proliferator-activated Receptor alpha Agonists

Medical Subject Heading (MeSH) Categories for gemfibrozil

Cytochrome P-450 CYP2C8 Inhibitors
Hypolipidemic Agents

Synonyms for gemfibrozil

1A Brand of Gemfibrozil
2,2-Dimethyl-5-(2,5-dimethylphenoxy)-pentanoic acid
2,2-Dimethyl-5-(2,5-dimethylphenoxy)pentanoic acid
2,2-Dimethyl-5-(2,5-dimethylphenoxy)valeriansaeure
2,2-Dimethyl-5-(2,5-dimethylphenoxy)valeric Acid
2,2-Dimethyl-5-(2,5-xylyloxy)valeriansaeure
2,2-Dimethyl-5-(2,5-xylyloxy)valeric acid
2,2-Dimethyl-5-(2,5-zlyloxy)valeric acid
25812-30-0
4TX
5-(2,5-Dimethyl-Phenoxy)-2,2-Dimethyl-Pentanoic Acid
5-(2,5-dimethylphenoxy)-2,2-dimethyl-pentanoic acid
5-(2,5-Dimethylphenoxy)-2,2-dimethylpentanoic acid
5-(2,5-DIMETHYLPHYLPHENOXY)-2,2-DIMETHYLPENTANOIC ACID
5-[(2,5-dimethylphenyl)oxy]-2,2-dimethylpentanoic acid
A0G461
A818037
AB00052003
AB00052003_17
AB00052003_18
AB00052003-15
AB00052003-16
AB0013344
AB03034
AB2000253
AC-4225
AC1L1FZT
AC1Q2JC7
AKOS001606691
Alphapharm Brand of Gemfibrozil
AN-12208
API0002816
Apo Gemfibrozil
Apo-Gemfibrozil
ApoGemfibrozil
Apotex Brand of Gemfibrozil
ARONIS24091
Ausgem
AX8032912
Bayvit Brand of Gemfibrozil
Bayvit, Gemfibrozilo
BB_SC-04837
BB_SC-4837
BBC/228
BBL010807
BDBM50110590
Bexal Brand of Gemfibrozil
BG0205
Biochemie Brand of Gemfibrozil
Bolutol
BPBio1_000251
BRD-K11129031-001-05-1
BRN 1881200
Brozil
BSPBio_000227
BSPBio_002060
Bull Brand of Gemfibrozil
C-15436
C07020
Cantabria Brand of Gemfibrozil
CAS-25812-30-0
CC-28946
CCG-40111
CCRIS 318
CG0035
CHEBI:5296
Chem mart Brand of Gemfibrozil
Chem mart Gemfibrozil
CHEMBL457
Cholespid
CI 719
CI-719
CI719
Clearol
CPD000058393
CS-2244
D00334
D05VIX
DB01241
DBL Gemfibrozil
Decrelip
DivK1c_000138
DL-414
Douglas Brand of Gemfibrozil
DR000672
DSSTox_CID_652
DSSTox_GSID_20652
DSSTox_RID_75712
DTXSID0020652
EINECS 247-280-2
Elmogan
Farmasierra Brand of Gemfibrozil
Faulding Brand of Gemfibrozil
Ferrer Brand of Gemfibrozil
Fetinor
Fibratol
Fibrocit
FT-0626641
FT-0700924
G0368
Gem-S
Gemcor
Gemcor, Lopid, Jezil,Gen-Fibro, Gemfibrozil
Gemcor;Jezil;Gen-Fibro;Lopid
Gemd
Gemfi 1A Pharma
Gemfibril
Gemfibromax
Gemfibrosil
Gemfibrozil (JAN/USP/INN)
Gemfibrozil (Lopid)
GEMFIBROZIL (SEE ALSO PEROXISOME PROJECT (GEMFIBROZIL))
Gemfibrozil [USAN:BAN:INN]
Gemfibrozil [USAN:USP:INN:BAN]
Gemfibrozil for system suitability, European Pharmacopoeia (EP) Reference Standard
Gemfibrozil, analytical standard
Gemfibrozil, British Pharmacopoeia (BP) Reference Standard
Gemfibrozil, European Pharmacopoeia (EP) Reference Standard
Gemfibrozil, GenRX
Gemfibrozil, Healthsense
Gemfibrozil, pharmaceutical secondary standard; traceable to USP, PhEur and BP
Gemfibrozil, SBPA
Gemfibrozil, United States Pharmacopeia (USP) Reference Standard
Gemfibrozilo
Gemfibrozilo [INN-Spanish]
Gemfibrozilo Bayvit
Gemfibrozilo Bexal
Gemfibrozilo Ur
Gemfibrozilum
Gemfibrozilum [INN-Latin]
Gemhexal
Gemlipid
Gemnpid
Gen Gemfibrozil
Gen-Fibro
Gen-Fibro (TN)
Gen-Gemfibrozil
GenGemfibrozil
Genlip
Genpharm Brand of Gemfibrozil
GenRX Gemfibrozil
Gevilon
Gevilon Uno
GFZ
Gozid
GP1460
GTPL3439
H900
Healthsense Brand of Gemfibrozil
Healthsense Gemfibrozil
HEMJJKBWTPKOJG-UHFFFAOYSA-N
Hexal Brand of Gemfibrozil
Hidil
Hipolixan
HMS1568L09
HMS1920B07
HMS2090K14
HMS2091H11
HMS2095L09
HMS2230H24
HMS3259M12
HMS3655C06
HMS500G20
HSDB 7735
HY-B0258
I01-1855
IDI1_000138
Innogem
Innogen
Ipolipid
Ipsen Brand of Gemfibrozil
J10068
Jezil
Jezil (TN)
KBio1_000138
KBio2_001305
KBio2_003873
KBio2_006441
KBio3_001280
KBioGR_000964
KBioSS_001305
KS-00000VK6
KS-000046JO
KS-5192
Lanaterom
Lifibron
Lipazil
Lipigem
Lipira
Lipizyl
Lipox Gemfi
Lipozid
Lipur
Litarek
Lopid
Lopid (TN)
Lopid R
lopizid
Low-Lip
LS-1085
MCULE-4563546953
Menarini Brand of Gemfibrozil
MFCD00079335
Micolip
MLS000028421
MLS001055364
MLS006011850
MolPort-001-794-413
NC00565
NCGC00016794-01
NCGC00016794-02
NCGC00016794-03
NCGC00016794-04
NCGC00016794-05
NCGC00016794-06
NCGC00016794-07
NCGC00016794-08
NCGC00016794-09
NCGC00016794-10
NCGC00016794-11
NCGC00016794-13
NCGC00016794-14
NCGC00022722-03
NCGC00022722-04
NCGC00022722-05
NCGC00022722-06
NCGC00022722-07
NCGC00256601-01
NCGC00259546-01
NINDS_000138
Normolip
Novo Gemfibrozil
Novo-Gemfibrozil
Novopharm Brand of Gemfibrozil
NSC-757024
NSC757024
Nu Gemfibrozil
Nu Pharm Brand of Gemfibrozil
Nu-Gemfibrozil
Nu-Pharm Brand of Gemfibrozil
NuGemfibrozil
Opera_ID_1658
OR249362
Parke Davis Brand of Gemfibrozil
Pentanoic acid, 5-(2,5-dimethylphenoxy)-2,2-dimethyl-
PEROXISOME PROJECT (GEMFIBROZIL) (SEE ALSO GEMFIBROZIL)
Pfizer Brand of Gemfibrozil
Pharmakon1600-10500313
Pharmascience Brand of Gemfibrozil
Pilder
PMS Gemfibrozil
PMS-Gemfibrozil
Polyxit
Prestwick_637
Prestwick0_000214
Prestwick1_000214
Prestwick2_000214
Prestwick3_000214
Progemzal
Q8X02027X3
Quimifar Brand of Gemfibrozil
Reducel
Regulip
Renabrazin
s1729
SAM002564211
SBB012457
SBI-0051391.P003
SBPA Gemfibrozil
SC-17669
SCHEMBL4813
SEL11160931
Sigma Brand of Gemfibrozil
Sinelip
SMR000058393
SPBio_001174
SPBio_002148
Spectrum_000825
SPECTRUM1500313
Spectrum2_001097
Spectrum3_000440
Spectrum4_000562
Spectrum5_000750
Spectrum5_001991
SR-01000000056
SR-01000000056-3
SR-01000000056-6
ST072198
STK618740
Synbrozil
Taborcil
TAD Brand of Gemfibrozil
Tentroc
Terry White Chemists Brand of Gemfibrozil
Terry White Chemists Gemfibrozil
TEVA-A
TL8002081
Tox21_110613
Tox21_110613_1
Tox21_201997
Tox21_302784
Trialmin
UNII-Q8X02027X3
United Drug Brand of Gemfibrozil
VA11004
Valeric acid, 2,2-dimethyl-5-(2,5-xylyloxy)-
W-107216
Warner Lambert Brand of Gemfibrozil
Warner-Lambert Brand of Gemfibrozil
WL-Gemfibrozil
Z-0832
ZINC1530641
ZX-AS004442

Tentative approvals for GEMFIBROZIL

Applicant	Application No.	Strength	Dosage Form
➤ Sign Up	➤ Sign Up	300MG	CAPSULE;ORAL

US Patents and Regulatory Information for gemfibrozil

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	GEMFIBROZIL	gemfibrozil	TABLET;ORAL	074156-001	Oct 24, 1994		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Pfizer Pharms	LOPID	gemfibrozil	CAPSULE;ORAL	018422-002	Approved Prior to Jan 1, 1982		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Pfizer Pharms	LOPID	gemfibrozil	TABLET;ORAL	018422-003	Nov 20, 1986	AB	RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Teva	GEMFIBROZIL	gemfibrozil	TABLET;ORAL	074256-001	Oct 31, 1993	AB	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 gemfibrozil

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Pharms	LOPID	gemfibrozil	CAPSULE;ORAL	018422-001	Approved Prior to Jan 1, 1982	➤ Sign Up	➤ Sign Up
Pfizer Pharms	LOPID	gemfibrozil	CAPSULE;ORAL	018422-002	Approved Prior to Jan 1, 1982	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration