Cobicistat; darunavir - Generic Drug Details
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What are the generic 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Japan | 2009542696 | ⤷ Sign Up | |
Portugal | 2393485 | ⤷ Sign Up | |
Japan | 2019059790 | 治療薬の薬物動態特性の調節 (MODULATION OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS) | ⤷ Sign Up |
Spain | 2546378 | ⤷ Sign Up | |
Norway | 20090593 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cobicistat; darunavir
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2049506 | C02049506/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: COBICISTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62673 18.10.2013 |
2487166 | PA2016038 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119 |
2487166 | 17C1001 | France | ⤷ Sign Up | PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET TENOFOVIR ALAFENAMIDE SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/15/1061 20151123 |
2049506 | C20150046 00250 | Estonia | ⤷ Sign Up | PRODUCT NAME: KOBITSISTAAT;REG NO/DATE: EU/1/13/830/001-002 27.05.2013 |
3150586 | 18/2020 | Austria | ⤷ Sign Up | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, DARUNAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT, UND EMTRICITABIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/17/1225 20170925 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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