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 patent protection?
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
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 | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | 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 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Lithuania | 2682397 | ⤷ Sign Up | |
European Patent Office | 3808743 | DERIVES D'UNE PYRIMIDINE EN TANT QU'INHIBITEUR DU VIH (HIV REPLICATION INHIBITING PYRIMIDINES) | ⤷ Sign Up |
Norway | 2016006 | ⤷ Sign Up | |
Australia | 8294101 | ⤷ Sign Up | |
Czech Republic | 304886 | Prekurzory léčiv na bázi fosfonátových analogů nukleotidů a způsoby jejich výběru a přípravy (Medicament precursors based on phosphonate nucleotide analogs, processes of their selection and preparation) | ⤷ Sign Up |
Spain | 2542017 | ⤷ Sign Up | |
Costa Rica | 20140072 | HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA | ⤷ Sign Up |
>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 |
---|---|---|---|---|
0513200 | 122004000015 | Germany | ⤷ Sign Up | PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024 |
1632232 | 93385 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE CHLORHYDRATE DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, EMTRICITABINE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE |
1663240 | 59/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
1419152 | 132012902054377 | Italy | ⤷ Sign Up | PRODUCT NAME: EMTRICITABINA/RILPIVIRINA CLORIDRATO/TENOFOVIR DISOPROXIL FUMARATO(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128 |
1419152 | 125 5007-2012 | Slovakia | ⤷ Sign Up | PRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 20111128 |
1663240 | PA2015037,C1663240-2 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU PRIIMTINOS JO FORMOS, TOKIOS KAIP RILPIVIRINO DRUSKOS,ISKAITANT RILPIVIRINO HIDROCHLORIDA, TENOFOVIRO, YPAC TENOFOVIRO DIZOPROKSILIO FUMARATO, IR EMTRICITABINODERINYS; REGISTRATION NO/DATE: EU/1/11/737/001 2011-11-28, EU/1/11/737/002 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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