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Last Updated: March 19, 2024

VITEKTA Drug Patent 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 ninety-two patent family members in thirty-six 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.

DrugPatentWatch® 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 April 26, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for VITEKTA
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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

VITEKTA is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VITEKTA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VITEKTA

4-oxoquinoline compound and use thereof as pharmaceutical agent
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Stable crystal of 4-oxoquinoline compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Stable crystal of 4-oxoquinoline compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
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 203093-001 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 VITEKTA

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 VITEKTA

When does loss-of-exclusivity occur for VITEKTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 9280
Estimated Expiration: ⤷  Try a Trial

Patent: 6100
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 05245296
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0510114
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 66922
Estimated Expiration: ⤷  Try a Trial

China

Patent: 56961
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0120681
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 13010
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 36190
Estimated Expiration: ⤷  Try a Trial

Patent: 81939
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 36190
Estimated Expiration: ⤷  Try a Trial

Patent: 14746
Estimated Expiration: ⤷  Try a Trial

Patent: 81939
Estimated Expiration: ⤷  Try a Trial

Patent: 99563
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 81939
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 83341
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 54064
Estimated Expiration: ⤷  Try a Trial

Patent: 06001927
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 81939
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 4672
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06013405
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 1839
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 9223
Estimated Expiration: ⤷  Try a Trial

Patent: 065790
Estimated Expiration: ⤷  Try a Trial

Patent: 161297
Estimated Expiration: ⤷  Try a Trial

Patent: 190051
Estimated Expiration: ⤷  Try a Trial

Patent: 200873
Estimated Expiration: ⤷  Try a Trial

Patent: 220690
Estimated Expiration: ⤷  Try a Trial

Patent: 230913
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 060358
Estimated Expiration: ⤷  Try a Trial

Patent: 120361
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 36190
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 36190
Estimated Expiration: ⤷  Try a Trial

Patent: 81939
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 30845
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 375
Estimated Expiration: ⤷  Try a Trial

Patent: 845
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 36190
Estimated Expiration: ⤷  Try a Trial

Patent: 81939
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0610647
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 080064909
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 88441
Estimated Expiration: ⤷  Try a Trial

Patent: 60824
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 29015
Estimated Expiration: ⤷  Try a Trial

Patent: 0600097
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VITEKTA around the world.

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
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VITEKTA

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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.