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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Elvitegravir - Generic Drug Details

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

Elvitegravir is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elvitegravir has seventy-nine patent family members in thirty-three countries.

There are six drug master file entries for elvitegravir.

Recent Clinical Trials for elvitegravir

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

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1
Southampton Healthcare, Inc.Phase 4
CONRADPhase 1

See all elvitegravir clinical trials

Recent Litigation for elvitegravir

Identify potential future generic entrants

District Court Litigation
Case NameDate
JAPAN TOBACCO, INC. v. KAPPOS2010-06-17

See all elvitegravir litigation

Synonyms for elvitegravir
(S)-6-(3-chloro-2-fluorobenzyl)-1-(1-hydroxy-3-methylbutan-2-yl)-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
3-Quinolinecarboxylic acid, 6-((3-chloro-2-fluorophenyl)methyl)-1,4-dihydro-1-((1S)-1-(hydroxymethyl)-2-methylpropyl)-7-methoxy-4-oxo-
3-Quinolinecarboxylic acid, 6-[(3-chloro-2-fluorophenyl)methyl]-1,4-dihydro-1-[(1S)-1-isopropyl-2-hydroxyethyl]-7-methoxy-4-oxo-
4GDQ854U53
6-(3-Chloro-2-fluorobenzyl)-1-((2S)-1-hydroxy-3-methylbutan-2-yl)-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
6-(3-chloro-2-fluorobenzyl)-1-[(1S)-1-(hydroxymethyl)-2-methylpropyl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
6-(3-chloro-2-fluorobenzyl)-1-[(2S)-1-hydroxy-3-methylbutan-2-yl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
6-(3-chloro-2-fluorobenzyl)-1-[(S)-1-hydroxymethyl-2-methylpropyl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
6-(3-Chloro-2-fluorobenzyl)-1-[1(S)-(hydroxymethyl)-2-methylpropyl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
6-[(3-chloro-2-fluoro-phenyl)methyl]-1-[(1S)-1-(hydroxymethyl)-2-methyl-propyl]-7-methoxy-4-oxo-quinoline-3-carboxylic acid
6-[(3-chloro-2-fluorophenyl)methyl]-1-[(2S)-1-hydroxy-3-methylbutan-2-yl]-7-methoxy-4-oxoquinoline-3-carboxylic acid
697761-98-1
697761-98-1, Pamine
A4070
AB0008021
AB01274749_02
AB01274749-01
ABP000243
AC-29947
AC1NQQ4E
AKOS025396642
AOB6957
API0007313
AS-16986
BC219612
BCP9000642
BCPP000242
BDBM50183273
BRD-K54472332-001-01-8
C23H23CLFNO5
CHEBI:72289
CHEMBL204656
CS-0439
D06677
DB09101
ELV
Elvitegravir (GS-9137, JTK-303)
Elvitegravir (GS-9137)
Elvitegravir (JAN/USAN)
Elvitegravir [USAN:INN]
Elvitegravir,EVG,GS-9137,JTK-303/
Elvitegravir(GS-9137)
elvitegravirum
EVG
EX-A1542
FT-0667840
GS 9137
GS-9137
GS9137
HY-14740
J-518006
JTK 303
JTK-303
JUZYLCPPVHEVSV-LJQANCHMSA-N
KS-0000001C
MLS006011136
MolPort-009-679-398
NCGC00346565-01
PubChem19145
QC-10447
RL04670
s2001
SB16498
SC-93621
SCHEMBL726252
SMR004702914
SW219721-1
UNII-4GDQ854U53
Vitekta
Vitekta (TN)
X5031
ZINC13682481

US Patents and Regulatory Information for elvitegravir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc VITEKTA elvitegravir TABLET;ORAL 203093-001 Sep 24, 2014 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc VITEKTA elvitegravir TABLET;ORAL 203093-002 Sep 24, 2014 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc VITEKTA elvitegravir TABLET;ORAL 203093-001 Sep 24, 2014 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc VITEKTA elvitegravir TABLET;ORAL 203093-002 Sep 24, 2014 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc VITEKTA elvitegravir TABLET;ORAL 203093-001 Sep 24, 2014 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc VITEKTA elvitegravir TABLET;ORAL 203093-002 Sep 24, 2014 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for elvitegravir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1564210 59/2013 Austria   Start Trial PRODUCT NAME: ELVITEGRAVIR ODER EIN HYDRAT, SOLVAT ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830/001- EU/1/13/830/002 (MITTEILUNG) 20130527
1564210 PA2013018 Lithuania   Start Trial PRODUCT NAME: ELVITEGRAVIRUM; REGISTRATION NO/DATE: EU/1/13/830/001, 2013 05 24 EU/1/13/830/002 20130524
1564210 2013/052 Ireland   Start Trial PRODUCT NAME: ELVITEGRAVIR OR A HYDRATE, SOLVATE, TAUTOMER OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
1564210 C 2013 033 Romania   Start Trial PRODUCT NAME: ELVITEGRAVIR OPTIONAL SUB FORMA DE SARE, SOLVAT SAU HIDRATACCEPTABILFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/830/001, EU/1/13/830/002; DATE OF NATIONAL AUTHORISATION: 20130524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/830/001, EU/1/13/830/002; DATE OF FIRST AUTHORISATION IN EEA: 20130524
1564210 C01564210/01 Switzerland   Start Trial PRODUCT NAME: ELVITEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 62673 18.10.2013
1564210 122013000088 Germany   Start Trial PRODUCT NAME: ELVITEGRAVIR ODER EIN HYDRAT, SOLVAT, TAUTOMER ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 20130524
1564210 SPC/GB13/065 United Kingdom   Start Trial PRODUCT NAME: ELVITEGRAVIR; REGISTERED: UK EU/1/13/830/001 20130527; UK EU/1/13/830/002 20130527
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Express Scripts
Harvard Business School
McKesson
Medtronic

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