COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details
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What are the generic drug sources for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate and what is the scope of freedom to operate?
Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate
is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate has four hundred and eighty-five patent family members in fifty-one countries.
One supplier is listed for this compound.
Summary for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
International Patents: | 485 |
US Patents: | 8 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 3 |
DailyMed Link: | COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Generic Entry Date for COBICISTAT; DARUNAVIR; 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; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Janssen Sciences Ireland UC | Phase 3 |
Janssen R&D Ireland | Phase 3 |
Gilead Sciences | Phase 2 |
See all COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE clinical trials
Pharmacology for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SYMTUZA | Tablets | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | 800 mg/150 mg/ 200 mg/10 mg | 210455 | 1 | 2021-08-16 |
US Patents and Regulatory Information for COBICISTAT; DARUNAVIR; 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | 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 |
Expired US Patents for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Montenegro | 02612 | TENOFOVIR ALAFENAMID HEMIFUMARAT (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) | ⤷ Sign Up |
Canada | 2653374 | MODULATEURS DE PROPRIETES PHARMACOCINETIQUES D'AGENTS THERAPEUTIQUES (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS) | ⤷ Sign Up |
Croatia | P20151357 | ⤷ Sign Up | |
Lithuania | 2487162 | ⤷ Sign Up | |
Japan | 4881433 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2487163 | 17C1000 | France | ⤷ Sign Up | PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET ATAZANAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER LE SULFATE D'ATAZANAVIR; REGISTRATION NO/DATE: EU/1/15/1025 20150715 |
2487166 | 122016000104 | Germany | ⤷ Sign Up | 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 |
2049506 | PA2015040,C2049506 | Lithuania | ⤷ Sign Up | PRODUCT NAME: KOBICISTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524 |
2487166 | 2016C/065 | Belgium | ⤷ Sign Up | PRODUCT NAME: COBICISTAT AND TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/15/1061 20151123 |
2049506 | C201530064 | Spain | ⤷ Sign Up | 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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