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Last Updated: March 19, 2024

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 ninety-two patent family members in thirty-six countries.

There are six drug master file entries for elvitegravir.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for elvitegravir
Generic Entry Date for elvitegravir*:
Constraining patent/regulatory exclusivity:
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 Clinical Trials for elvitegravir

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

SponsorPhase
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaN/A
University of California, Los AngelesEarly Phase 1
Merck Sharp & Dohme Corp.Early Phase 1

See all elvitegravir clinical trials

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

EU/EMA Drug Approvals for elvitegravir

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gilead Sciences International Ltd Vitekta elvitegravir EMEA/H/C/002577
Vitekta co-administered with a ritonavir-boosted protease inhibitor and with other antiretroviral agents, is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir.
Withdrawn no no no 2013-11-13
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for elvitegravir

Country Patent Number Title Estimated Expiration
Argentina 096100 CRISTAL ESTABLE DE DERIVADO DE 4-OXOQUINOLINA, SU USO COMO AGENTE ANTI-HIV Y SU USO EN COMPOSICIONES ANTI-HIV ⤷  Try a Trial
Norway 20161297 Stabil krystall av 4-oxoquinolinforbindelse ⤷  Try a Trial
South Africa 200610647 Stable crystal of 4-oxoquinoline compound ⤷  Try a Trial
Norway 20230913 Stabil krystall av 4-oxoquinolinforbindelse ⤷  Try a Trial
Serbia 52375 STABILNI KRISTALI JEDINJENJA 4-OKSOHINOLINA (STABLE CRYSTAL OF 4-OXOQUINOLINE COMPUND) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for elvitegravir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1564210 2013/052 Ireland ⤷  Try a 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 203 5022-2013 Slovakia ⤷  Try a Trial PRODUCT NAME: ELVITEGRAVIR ALEBO JEHO HYDRAT, SOLVAT, TAUTOMER ALEBO FARMACEUTICKY PRIJATELNA SOL; NAT. REGISTRATION NO/DATE: EU/1/13/830/001 - EU/1/13/830/002 20130527; FIRST REGISTRATION: EU EU/1/13/830/001 - EU/1/13/830/002 20130527
1564210 300624 Netherlands ⤷  Try a Trial PRODUCT NAME: ELVITEGRAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, SOLVAAT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
1564210 1390052-7 Sweden ⤷  Try a Trial PRODUCT NAME: ELVITEGRAVIR ELLER ETT HYDRAT, ETT SOLVAT, EN TAUTOMER, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/13/830/001 20130524; PERIOD OF VALIDITY (FROM - UNTIL): 2023-11-21 - 2028-05-26
2487166 PA2016038 Lithuania ⤷  Try a Trial PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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