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Last Updated: July 13, 2020

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STRIBILD Drug Profile


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Which patents cover Stribild, and when can generic versions of Stribild launch?

Stribild is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has five hundred and ninety-four patent family members in fifty-four countries.

The generic ingredient in STRIBILD is cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate profile page.

US ANDA Litigation and Generic Entry Outlook for Stribild

Stribild 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 4, 2032. This may change due to patent challenges or generic licensing.

There have been eighteen patent litigation cases 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 STRIBILD
Drug Prices for STRIBILD

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Generic Entry Opportunity Date for STRIBILD
Generic Entry Date for STRIBILD*:
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 Clinical Trials for STRIBILD

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

SponsorPhase
Gilead SciencesPhase 1/Phase 2
University of California, Los AngelesPhase 1/Phase 2
ViiV HealthcareN/A

See all STRIBILD clinical trials

Paragraph IV (Patent) Challenges for STRIBILD
Tradename Dosage Ingredient NDA Submissiondate
STRIBILD TABLET;ORAL cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate 203100 2018-10-04

US Patents and Regulatory Information for STRIBILD

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 STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes   Start Trial   Start Trial 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

Expired US Patents for STRIBILD

Supplementary Protection Certificates for STRIBILD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1564210 PA2013018,C1564210 Lithuania   Start Trial PRODUCT NAME: ELVITEGRAVIRUM; REGISTRATION NO/DATE: EU/1/13/830/001, 2013-05-24 EU/1/13/830/002 20130524
3150586 PA2020508 Lithuania   Start Trial PRODUCT NAME: KOBICISTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, DARUNAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS, IR EMTRICITABINAS, ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/17/1225 20170921
2049506 C201530064 Spain   Start Trial PRODUCT NAME: COBICISTAT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/13/830; DATE OF AUTHORISATION: 20130524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/830; DATE OF FIRST AUTHORISATION IN EEA: 20130524
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Baxter
Johnson and Johnson
Mallinckrodt
Express Scripts
Moodys

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.