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Last Updated: March 29, 2024

Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details


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What are the generic sources for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate and what is the scope of patent protection?

Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate has four hundred and forty-eight patent family members in forty-eight countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Generic Entry Date for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate*:
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 cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

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

SponsorPhase
Gilead SciencesPhase 1/Phase 2
University of California, Los AngelesPhase 1/Phase 2
Brigham and Women's HospitalN/A

See all cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate clinical trials

Paragraph IV (Patent) Challenges for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
STRIBILD Tablets cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate 150 mg/150 mg/ 200 mg/300 mg 203100 1 2018-10-04

US Patents and Regulatory Information for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

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

Expired US Patents for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

Supplementary Protection Certificates for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

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
2487166 122016000104 Germany ⤷  Try a Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND TENOFOVIRALAFENAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2487163 PA2016039 Lithuania ⤷  Try a Trial PRODUCT NAME: ATAZANAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713
>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.