Cobicistat; darunavir - Generic Drug Details
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What are the generic sources for cobicistat; darunavir and what is the scope of patent protection?
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | 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 cobicistat; darunavir
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 |
---|---|---|---|
Norway | 2017002 | ⤷ Try a Trial | |
European Patent Office | 2393485 | COMPRIMÉ BICOUCHE CONTENANT DE L'ELVITEGRAVIR, DU COBICISTAT, DE L'EMTRICITABINE ET DU TENOFOVIR (BILAYER TABLETS COMPRISING ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR) | ⤷ Try a Trial |
Norway | 2020011 | ⤷ 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 |
---|---|---|---|---|
2487163 | 2017002 | Norway | ⤷ Try a Trial | PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK; REG. NO/DATE: EU/1/15/1025 20150810 |
2487166 | 59/2016 | Austria | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND TENOFOVIR ALAFENAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE TENOFOVIR ALAFENAMID FUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 (MITTEILUNG) 20151123 |
2487162 | CA 2017 00002 | Denmark | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF OG DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIRETHANOLAT; REG. NO/DATE: EU/1/14/967/001 20141121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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