EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details
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What are the generic drug sources for emtricitabine; tenofovir alafenamide fumarate and what is the scope of freedom to operate?
Emtricitabine; tenofovir alafenamide fumarate
is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc and Apotex, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Emtricitabine; tenofovir alafenamide fumarate has one hundred and thirty-two patent family members in fifty countries.
One supplier is listed for this compound.
Summary for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
International Patents: | 132 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 41 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
DailyMed Link: | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE at DailyMed |
Recent Clinical Trials for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
ANRS, Emerging Infectious Diseases | Phase 3 |
Assistance Publique - Hôpitaux de Paris, FRANCE | Phase 3 |
Ministry of Health, Thailand | Phase 3 |
See all EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE clinical trials
Pharmacology for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
DESCOVY | Tablets | emtricitabine; tenofovir alafenamide fumarate | 120 mg/15 mg | 208215 | 1 | 2022-10-31 |
DESCOVY | Tablets | emtricitabine; tenofovir alafenamide fumarate | 200 mg/25 mg | 208215 | 6 | 2019-11-05 |
US Patents and Regulatory Information for 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex | EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 214053-001 | May 17, 2024 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-002 | Jan 7, 2022 | RX | Yes | No | ⤷ 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 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2020040972 | テノホビルアラフェナミドヘミフマレート (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) | ⤷ Sign Up |
Taiwan | I516499 | ⤷ Sign Up | |
Brazil | PI0112646 | pró-fármacos de análogos de nucleotídeo de fosfonato e composições que as compreende | ⤷ Sign Up |
African Intellectual Property Organization (OAPI) | 12393 | Prodrugs of phosphonate nucleotide analogues and methods for selecting and making same. | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1301519 | CA 2016 00012 | Denmark | ⤷ Sign Up | PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123 |
1301519 | 300803 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123 |
1663240 | 15C0071 | France | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
1301519 | PA2016009 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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