COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details
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What are the generic drug sources for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate and what is the scope of freedom to operate?
Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate has five hundred and twenty-six patent family members in fifty-six countries.
One supplier is listed for this compound.
Summary for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
International Patents: | 526 |
US Patents: | 10 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 11 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
DailyMed Link: | COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Generic Entry Date for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE 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 ALAFENAMIDE FUMARATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Gilead Sciences | Phase 1/Phase 2 |
University of California, Los Angeles | Phase 1/Phase 2 |
Brigham and Women's Hospital | N/A |
See all COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE clinical trials
Pharmacology for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
GENVOYA | Tablets | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | 150 mg/150 mg/ 200 mg/10 mg | 207561 | 1 | 2023-04-12 |
US Patents and Regulatory Information for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE 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 | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | 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 |
Expired US Patents for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 1636190 | ⤷ Sign Up | |
Portugal | 2393485 | ⤷ Sign Up | |
South Africa | 200610647 | Stable crystal of 4-oxoquinoline compound | ⤷ Sign Up |
Poland | 213214 | ⤷ Sign Up | |
Canada | 2566922 | CRISTAL STABLE DE COMPOSE 4-OXOQUINOLINE (STABLE CRYSTAL OF 4-OXOQUINOLINE COMPOUND) | ⤷ Sign Up |
European Patent Office | 3287130 | COMBINAISONS COMPORTANT UN DÉRIVÉ D'ISOQUINOLONE 4 ET INHIBITEURS DE LA PROTEASE (COMBINATIONS COMPRISING A 4-ISOQUINOLONE DERIVATIVE AND PROTEASE INHIBITORS) | ⤷ Sign Up |
Cyprus | 2020011 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2487166 | 132017000002828 | Italy | ⤷ Sign Up | PRODUCT NAME: COBICISTAT O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO E TENOFOVIR ALAFENAMIDE O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123 |
3150586 | PA2020508 | Lithuania | ⤷ Sign Up | 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 |
2487166 | 2017003 | Norway | ⤷ Sign Up | PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV OG TENOFOVIR ALAFENAMID ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV, SPESIELT TENOFOVIR ALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061 20151209 |
2487163 | PA2016039,C2487163 | Lithuania | ⤷ Sign Up | PRODUCT NAME: KOBICISTATAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA IR ATAZANAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC ATAZANAVIRO SULFATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713 |
1564210 | 1390052-7 | Sweden | ⤷ Sign Up | PRODUCT NAME: ELVITEGRAVIR ELLER ETT HYDRAT, ETT SOLVAT, EN TAUTOMER, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/13/830/001 20130524; PERIOD OF VALIDITY (FROM - UNTIL): 2023-11-21 - 2028-05-26 |
2487163 | C20170001 00217 | Estonia | ⤷ Sign Up | PRODUCT NAME: ATASANAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/15/1025 15.07.2015 |
2487163 | 60/2016 | Austria | ⤷ Sign Up | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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