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Last Updated: December 5, 2020

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Elvitegravir - Generic Drug Details

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What are the generic 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-four countries.

There are six drug master file entries for elvitegravir.

Recent Clinical Trials for elvitegravir

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

SponsorPhase
Fundacio Lluita Contra la SIDAPhase 1
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1
Southampton Healthcare, Inc.Phase 4

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 203093-002 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 203093-001 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 elvitegravir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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 92307 Luxembourg   Start Trial PRODUCT NAME: ELVIEGRAVIR SOUS TOUTES SES FORMES COMME PROTEGEES PAR LE BREVET DE BASE
1564210 CA 2013 00058 Denmark   Start Trial PRODUCT NAME: ELVITEGRAVIR I ENHVER FORM SOM ER OMFATTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/13/830/001-002 20130524
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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