EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE - Generic Drug Details
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What are the generic drug sources for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate and what is the scope of freedom to operate?
Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate has three hundred and thirty-four patent family members in fifty-two countries.
One supplier is listed for this compound.
Summary for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
International Patents: | 334 |
US Patents: | 7 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 11 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE |
DailyMed Link: | EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Generic Entry Date for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL 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 DISOPROXIL FUMARATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Janssen Pharmaceutical K.K. | Phase 4 |
Gilead Sciences | Phase 4 |
Azienda Ospedaliera San Gerardo di Monza | Phase 4 |
See all EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE clinical trials
Pharmacology for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
COMPLERA | Tablets | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | 200 mg/25 mg/ 300 mg | 202123 | 1 | 2015-05-20 |
US Patents and Regulatory Information for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Expired US Patents for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
International Patents for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1923063 | Compositions et procédés pour une thérapie antivirale combinée (Compositions and methods for combination antiviral therapy) | ⤷ Try a Trial |
South Africa | 200601820 | Combinations of a pyrimidine containing NNRTI with RT inhibitors | ⤷ Try a Trial |
Spain | 2542017 | ⤷ Try a Trial | |
Denmark | 1632232 | ⤷ Try a Trial | |
Poland | 368270 | Pochodne pirymidyn hamujące wirusa HIV (HIV INHIBITING PYRIMIDINES DERIVATIVES) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1663240 | 92853 | Luxembourg | ⤷ Try a Trial | 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 ET L'EMTRICITABINE |
1419152 | C20120012 00058 | Estonia | ⤷ Try a Trial | PRODUCT NAME: EVIPLERA - EMTRITSITABIIN/RILPIVIRIIN (HUEDRO-;REG NO/DATE: C(2011)8956 FINAL 28.11.2011 |
1419152 | PA2012008 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRINUM; REGISTRATION NO/DATE: EU/1/11/736/001 20111128 |
1632232 | 132016000129226 | Italy | ⤷ Try a Trial | PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA CLORIDRATO O UNA SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, 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 | 132012902053326 | Italy | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRINA CLORIDRATO(EDURANT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/736/001, 20111128 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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