Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate - Generic Drug Details
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What are the generic drug sources for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate and what is the scope of freedom to operate?
Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate has three hundred and thirty-one patent family members in fifty-seven countries.
One supplier is listed for this compound.
Summary for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
International Patents: | 331 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 2 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate |
DailyMed Link: | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
Generic Entry Date for emtricitabine; rilpivirine hydrochloride; 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; rilpivirine hydrochloride; tenofovir alafenamide fumarate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Gilead Sciences | Phase 3 |
See all emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate clinical trials
Pharmacology for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ODEFSEY | Tablets | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | 200 mg/25 mg/ 25 mg | 208351 | 3 | 2019-11-05 |
US Patents and Regulatory Information for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
Expired US Patents for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
International Patents for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 1632232 | ⤷ Try a Trial | |
Hong Kong | 1210029 | -氰基乙烯基 -二甲基苯基 氨基 -嘧啶基 氨基 苄腈的鹽酸鹽 (HYDROCHLORIDE OF 4-[[4-[[4-(2-CYANOETHENYL)-2,6- DIMETHYLPHENYL]AMINO]-2- PYRIMIDINYL]AMINO]BENZONITRILE 4-[[4-[[4-(2-)-26-]]-2-]]) | ⤷ Try a Trial |
Poland | 1632232 | ⤷ Try a Trial | |
Canada | 2845553 | HEMIFUMARATE DE TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) | ⤷ Try a Trial |
Hungary | S1600060 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1663240 | PA2016045 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621 |
1663240 | 1690061-5 | Sweden | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623 |
1663240 | 132016000129162 | Italy | ⤷ Try a Trial | PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA O UNA SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME UN SALE FARMACEUTICAMENTE ACCETTABILE DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, EMTRICITABINA, E TENOFOVIR ALAFENAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL TENOFOVIR ALAFENAMIDE EMIFUMARATO(ODEFSEY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1112, 20160623 |
1419152 | C 2012 016 | Romania | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE DE RILPIVIRINA SI TOATE FORMELE ECHIVALENTETERAPEUTIC ALE ACESTEIA CUM AR FI SARURILE DE ADITIE ALE RILPIVIRINEI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREARILPIVIRINEI CU ACIDUL CLORHIDRIC, SI TENOFOVIR, IN PARTICULAR FUMARAT DE TENOFOVIRDISOPROXIL; NATIONAL AUTHORISATION NUMBER: EU/1/11/737/001, EU/1/11/737/002; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/737/001, EU/1/11/737/002; DATE OF FIRST AUTHORISATION IN EEA: 20111128 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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