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Last Updated: December 5, 2020

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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-four 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 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 26, 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. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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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.

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
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 203093-002 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 VITEKTA

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
2487166 PA2016038 Lithuania   Start Trial PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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