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 11, 2019

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Gemfibrozil - Generic Drug Details

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What are the generic sources for gemfibrozil and what is the scope of 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, Yaopharma Co Ltd, and Zydus Pharms, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for gemfibrozil

See drug prices for gemfibrozil

Drug Sales Revenue Trends for gemfibrozil

See drug sales revenues for gemfibrozil

Recent Clinical Trials for gemfibrozil

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Seattle Genetics, Inc.Phase 1
CelgenePhase 1
Laboratorios Grossman, S.A.Phase 3

See all gemfibrozil clinical trials

Generic filers with tentative approvals for GEMFIBROZIL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial300MGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for gemfibrozil
Synonyms for 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-
5-(2,5-dimethylphenoxy)-2,2-dimethyl-pentanoic acid
5-(2,5-Dimethylphenoxy)-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
AN-12208
API0002816
Apo-Gemfibrozil
ARONIS24091
Ausgem
AX8032912
BB_SC-04837
BBC/228
BBL010807
BCP08437
BDBM50110590
BG0205
Bolutol
BPBio1_000251
BRD-K11129031-001-05-1
BRN 1881200
Brozil
BSPBio_000227
BSPBio_002060
C-15436
C07020
CAS-25812-30-0
CC-28946
CCG-40111
CCRIS 318
CG0035
CHEBI:5296
CHEMBL457
Cholespid
CI 719
CI-719
Clearol
CPD000058393
CS-2244
D00334
DB01241
Decrelip
dimethylpentanoic acid
DivK1c_000138
DL-414
DSSTox_CID_652
DSSTox_GSID_20652
DSSTox_RID_75712
DTXSID0020652
EINECS 247-280-2
Elmogan
Fetinor
Fibratol
Fibrocit
FT-0626641
FT-0700924
G0368
Gem-S
Gemcor
Gemcor;Jezil;Gen-Fibro;Lopid
Gemd
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, 98%
Gemfibrozil, analytical standard
Gemfibrozil, British Pharmacopoeia (BP) Reference Standard
Gemfibrozil, European Pharmacopoeia (EP) Reference Standard
Gemfibrozil, Pharmaceutical Secondary Standard; Certified Reference Material
Gemfibrozil, United States Pharmacopeia (USP) Reference Standard
Gemfibrozil,(S)
Gemfibrozilo
Gemfibrozilo [INN-Spanish]
Gemfibrozilum
Gemfibrozilum [INN-Latin]
Gemlipid
Gemnpid
Gen-Fibro
Genlip
Gevilon Uno
Gozid
GP1460
GTPL3439
H900
HEMJJKBWTPKOJG-UHFFFAOYSA-N
Hidil
Hipolixan
HMS1568L09
HMS1920B07
HMS2090K14
HMS2091H11
HMS2095L09
HMS2230H24
HMS3259M12
HMS3655C06
HMS3712L09
HMS500G20
HSDB 7735
HY-B0258
I01-1855
IDI1_000138
Innogem
Innogen
Ipolipid
J10068
Jezil
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
Lipozid
Lipur
Litarek
Lopid
Lopid (TN)
Lopid R
Low-Lip
LS-1085
MCULE-4563546953
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
NSC-757024
NSC757024
Nu-Gemfibrozil
Opera_ID_1658
Pentanoic acid, 5-(2,5-dimethylphenoxy)-2,2-dimethyl-
PEROXISOME PROJECT (GEMFIBROZIL) (SEE ALSO GEMFIBROZIL)
Pharmakon1600-10500313
Pilder
Polyxit
Prestwick_637
Prestwick0_000214
Prestwick1_000214
Prestwick2_000214
Prestwick3_000214
Progemzal
Q8X02027X3
Reducel
Regulip
Renabrazin
s1729
SAM002564211
SBB012457
SBI-0051391.P003
SC-17669
SCHEMBL4813
SEL11160931
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-01000000056-4
SR-01000000056-6
SR-01000000056-7
ST072198
STK618740
SW196802-3
Synbrozil
Taborcil
Tentroc
TEVA-A
TL8002081
Tox21_110613
Tox21_110613_1
Tox21_201997
Tox21_302784
Trialmin
UNII-Q8X02027X3
VA11004
Valeric acid, 2,2-dimethyl-5-(2,5-xylyloxy)-
W-107216
WL-Gemfibrozil
Z-0832
ZINC1530641
ZX-AS004442

US Patents and Regulatory Information for gemfibrozil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Yaopharma Co Ltd GEMFIBROZIL gemfibrozil TABLET;ORAL 074615-001 Sep 29, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Teva GEMFIBROZIL gemfibrozil TABLET;ORAL 074256-001 Oct 31, 1993 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan GEMFIBROZIL gemfibrozil CAPSULE;ORAL 073466-001 Jan 25, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma Pharms GEMFIBROZIL gemfibrozil TABLET;ORAL 078599-001 Aug 16, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs GEMFIBROZIL gemfibrozil TABLET;ORAL 074156-001 Oct 24, 1994 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan GEMFIBROZIL gemfibrozil TABLET;ORAL 074452-001 Feb 16, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Purepac Pharm GEMFIBROZIL gemfibrozil TABLET;ORAL 074360-001 Aug 31, 1994 DISCN 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 gemfibrozil

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

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