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Last Updated: December 14, 2019

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VITEKTA Drug Profile

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When do Vitekta patents expire, and when can generic versions of Vitekta launch?

Vitekta is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in VITEKTA is elvitegravir. There are six drug master file entries for this compound. Additional details are available on the elvitegravir profile page.

US ANDA Litigation and Generic Entry Outlook for Vitekta

Vitekta was eligible for patent challenges on August 27th, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 26th, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Historic data indicate that 48% of cases that proceed to trial are decided in favor of the generic patent challenger.

Drug patent expirations by year for VITEKTA
Generic Entry Opportunity Date for VITEKTA
Generic Entry Date for VITEKTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Litigation for VITEKTA

Identify potential future generic entrants

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

See all VITEKTA litigation

Synonyms for VITEKTA
(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
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 (TN)
X5031
ZINC13682481

US Patents and Regulatory Information for VITEKTA

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 203093-001 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 VITEKTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1564210 CR 2013 00058 Denmark   Start Trial PRODUCT NAME: ELVITEGRAVIR ELLER ET HYDRAT, ET SOLVAT, EN TAUTOMER ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Harvard Business School
AstraZeneca
Johnson and Johnson
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.