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 | 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 | |||
>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 |
---|---|---|---|
Hungary | S1600060 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2006024668 | ⤷ Sign Up | |
Costa Rica | 9032 | FUMARATO DE 4-((4-((4-(2-CIANOETENIL)-2,6-DIMETILFENIL)AMINO-2- PIRIMIDINIL)AMINO)BENZONITRILO | ⤷ Sign Up |
Japan | 2010077140 | HIV INHIBITING PYRIMIDINE DERIVATIVE | ⤷ Sign Up |
European Patent Office | 3070088 | TÉNOFOVIR ALAFENAMIDE HÉMIFUMARATE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) | ⤷ Sign Up |
African Intellectual Property Organization (OAPI) | 12393 | Prodrugs of phosphonate nucleotide analogues and methods for selecting and making same. | ⤷ Sign Up |
Norway | 2016025 | ⤷ 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 |
---|---|---|---|---|
1663240 | 132016000129162 | Italy | ⤷ Sign Up | 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 |
1632232 | PA2016043 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621 |
1663240 | C01663240/03 | Switzerland | ⤷ Sign Up | FORMER OWNER: JANSSEN SCIENCES IRELAND UC, IE |
1663240 | C 2015 038 | Romania | ⤷ Sign Up | PRODUCT NAME: COMBINATIE DE RILPIVIRINA SAU O FORMA TERAPEUTIC ECHIVALENTA A ACESTEIA, CUM AR FI O SARE DE RILPIVIRINA ACCEPTABILA FARMACEUTIC, INCLUSIV CLORHIDRATUL DE RILPIVIRINA SI EMTRICITABINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/737/001-002; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/737/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20111128 |
1663240 | 60/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
1663240 | 2015/054 | Ireland | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, AND TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
1663240 | 92855 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE , TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL, ET L'EMTRICITABINE. |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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