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Generated: March 19, 2019

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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 eighteen patents protecting this drug and one Paragraph IV challenge.

This drug has six hundred and fifty-three 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. Five suppliers are listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate profile page.

Drug patent expirations by year for STRIBILD
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.

Synonyms for STRIBILD
1430117-57-9
Cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil
Cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil fumarate
Cobicistat mixture with elvitegravir and emtricitabine and tenofovir disoproxil
Cobicistat mixture with elvitegravir, emtricitabine and tenofovir disoproxil fumarate
Cobicistat, elvitegravir, emtricitabine, tenofovir
Elvitegravir mixture with cobicistat and emtricitabine and tenofovir disoproxil fumarate
Elvitegravir-cobicistat-emtricitabine-tenofovir disoproxil fumarate
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
EVG-COBI-FTC-TDF
FMCLRHTZMTUYMI-JFQFMQNHSA-N
Quad
Quad pill
Quad Tablet

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for STRIBILD

Paragraph IV (Patent) Challenges for STRIBILD
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 150 mg, 150 mg, 200 mg, 300 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for STRIBILD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049506 2015/058 Ireland ➤ Sign Up PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/830/001-EU/1/13/830/002 20130524
2049506 PA2015040 Lithuania ➤ Sign Up PRODUCT NAME: COBICISTATUM; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
1564210 489 Finland ➤ Sign Up
1564210 C300624 Netherlands ➤ Sign Up PRODUCT NAME: ELVITEGRAVIR IN ALLE VORMEN ZOALS; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524
0915894 C00915894/01 Switzerland ➤ Sign Up PRODUCT NAME: TENOFOVIR DISOPROXILFUMARAT + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57316 21.03.2006
1564210 2013/052 Ireland ➤ Sign Up PRODUCT NAME: ELVITEGRAVIR OR A HYDRATE, SOLVATE, TAUTOMER OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; 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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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Cipla
Julphar
AstraZeneca
McKesson
Boehringer Ingelheim

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