COBICISTAT; DARUNAVIR - Generic Drug Details
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What are the generic drug sources for cobicistat; darunavir and what is the scope of freedom to operate?
Cobicistat; darunavir
is the generic ingredient in two branded drugs marketed by Janssen Prods and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.Cobicistat; darunavir has three hundred and forty-three patent family members in forty countries.
Two suppliers are listed for this compound.
Summary for COBICISTAT; DARUNAVIR
International Patents: | 343 |
US Patents: | 10 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Clinical Trials: | 55 |
DailyMed Link: | COBICISTAT; DARUNAVIR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COBICISTAT; DARUNAVIR
Generic Entry Date for COBICISTAT; DARUNAVIR*:
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 COBICISTAT; DARUNAVIR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
East Carolina University | Phase 4 |
Azienda Ospedaliero-Universitaria di Parma | Phase 2 |
University of Parma | Phase 2 |
Pharmacology for COBICISTAT; DARUNAVIR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PREZCOBIX | Tablets | cobicistat; darunavir | 800 mg/150 mg | 205395 | 1 | 2020-07-24 |
US Patents and Regulatory Information for COBICISTAT; DARUNAVIR
Expired US Patents for COBICISTAT; DARUNAVIR
EU/EMA Drug Approvals for COBICISTAT; DARUNAVIR
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Janssen-Cilag International N.V. | Rezolsta | darunavir, cobicistat | EMEA/H/C/002819 Rezolsta, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years or older.Genotypic testing should guide the use of Rezolsta. |
Authorised | no | no | no | 2014-11-19 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for COBICISTAT; DARUNAVIR
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Eurasian Patent Organization | 201270738 | МОДУЛЯТОРЫ ФАРМАКОКИНЕТИЧЕСКИХ СВОЙСТВ ЛЕКАРСТВЕННЫХ СРЕДСТВ | ⤷ Try a Trial |
Spain | 2601820 | ⤷ Try a Trial | |
South Korea | 101477822 | ⤷ Try a Trial | |
Hungary | E029866 | ⤷ Try a Trial | |
Hong Kong | 1164737 | 包括埃替拉韋, ,恩曲他濱和替諾福韋的雙層片劑 (BILAYER TABLETS COMPRISING ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR COBICISTAT) | ⤷ Try a Trial |
Australia | 2012205289 | Pseudopolymorphic forms of a HIV protease inhibitor | ⤷ Try a Trial |
Slovenia | 2049506 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for COBICISTAT; DARUNAVIR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2487166 | 132017000002828 | Italy | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO E TENOFOVIR ALAFENAMIDE O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123 |
2487163 | 1790002-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/15/1025, 2015-07-15 |
2487166 | CA 2017 00004 | Denmark | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123 |
2049506 | 122015000092 | Germany | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524 |
2487162 | PA2016040 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119 |
2487166 | 93354 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI ET ALAFENAMIDE DE TENOFOVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE D'ALAFENAMIDE DE TENOFOVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1061 |
3150586 | 132020000000055 | Italy | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, DARUNAVIR O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO, E EMTRICITABINE O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO(SYMTUZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1225, 20170925 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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