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 patent protection?
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 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: | 1 |
Applicants: | 1 |
NDAs: | 1 |
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for emtricitabine; tenofovir alafenamide fumarate
Generic Entry Date for 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 emtricitabine; tenofovir alafenamide fumarate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Chiang Mai University, Thailand | Phase 3 |
ANRS, Emerging Infectious Diseases | Phase 3 |
Assistance Publique - Hôpitaux de Paris, FRANCE | 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
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 | 2010174033 | PRODRUG OF PHOSPHONATE NUCLEOTIDE ANALOGUE AND METHOD FOR SCREENING AND PRODUCING THE SAME | ⤷ Try a Trial |
South Korea | 20140054068 | TENOFOVIR ALAFENAMIDE HEMIFUMARATE | ⤷ Try a Trial |
Ukraine | 75889 | ПРОЛЕКАРСТВА АНАЛОГОВ ФОСФОНАТНУКЛЕОТИДА, СПОСОБ ИХ СЕЛЕКЦИИ И ПОЛУЧЕНИЯ;ПРОЛІКИ АНАЛОГІВ ФОСФОНАТНУКЛЕОТИДУ, СПОСІБ ЇХ СЕЛЕКЦІЇ ТА ОДЕРЖАННЯ (PHOSPHONATNUCLEOTIDE ANALOGS PRODRUGS, A METHOD FOR SELECTION AND PREPARATION THEREOF) | ⤷ Try a Trial |
Japan | 2015038149 | テノホビルアラフェナミドヘミフマレート (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) | ⤷ Try a Trial |
European Patent Office | 1301519 | PROMEDICAMENTS A BASE D'ANALOGUES NUCLEOTIDIQUES DE PHOSPHONATE ET LEURS METHODES DE SELECTION ET D'ELABORATION (PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME) | ⤷ Try a Trial |
>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 |
---|---|---|---|---|
3808743 | 301190 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE OF EEN DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ADDITIEZOUT VAN RILPIVIRINE, MET INBEGRIP VAN HET HYDROCHLORIDE-ZOUT VAN RILPIVIRINE, EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
1301519 | C01301519/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TENOFOVIRALAFENAMID; REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 65793 01.09.2016 |
1663240 | 300851 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623 |
1663240 | 15C0073 | France | ⤷ Try a Trial | 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 DE TENOFOVIR EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
1301519 | 122016000024 | Germany | ⤷ Try a Trial | PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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