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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | ODEFSEY | emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate | TABLET;ORAL | 208351-001 | Mar 1, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Croatia | P20161696 | ⤷ Try a Trial | |
Canada | 2416757 | 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 |
Croatia | P20160074 | ⤷ Try a Trial | |
China | 101056673 | Hydrochloride of 4-((4-(4-(2-cyanoethenyl)-2,6-dimethylphenyl)amino)-2-pyrimidinyl)amino)benzonitrile | ⤷ 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 |
Norway | 2017065 | ⤷ Try a Trial | |
Australia | 2001282941 | ⤷ 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 | 222 6-2015 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: EMTRICITABIN/RILPIVIRINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128 |
0582455 | 08C0021 | France | ⤷ Try a Trial | PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213 |
1419152 | 162 5010-2012 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128 |
1632232 | 93385 | Luxembourg | ⤷ Try a Trial | 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 |
1419152 | PA2012008,C1419152 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRINUM; REGISTRATION NO/DATE: EU/1/11/736/001 20111128 |
1419152 | 132012902054377 | Italy | ⤷ Try a Trial | PRODUCT NAME: EMTRICITABINA/RILPIVIRINA CLORIDRATO/TENOFOVIR DISOPROXIL FUMARATO(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128 |
1663240 | 379 5033-2016 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/TENOFOVIR-ALAFENAMID VO VSETKYCH FORMACH CHRA- NENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1112 20160623 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.