DrugPatentWatch Database Preview
PREZCOBIX Drug Profile
Which patents cover Prezcobix, and what generic alternatives are available?
Prezcobix is a drug marketed by Janssen Prods and is included in one NDA. There are seven patents protecting this drug.
This drug has three hundred and thirty-two patent family members in forty-one countries.
The generic ingredient in PREZCOBIX is cobicistat; darunavir. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cobicistat; darunavir profile page.
Summary for PREZCOBIX
| International Patents: | 332 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 4 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PREZCOBIX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PREZCOBIX |
| DailyMed Link: | PREZCOBIX at DailyMed |
Generic Entry Opportunity Date for PREZCOBIX
Generic Entry Date for PREZCOBIX*:
Constraining patent/regulatory exclusivity:
NDA:
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 PREZCOBIX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Janssen Pharmaceutical K.K. | Phase 4 |
| Stanford University | Phase 2/Phase 3 |
| Janssen Scientific Affairs, LLC | Phase 2/Phase 3 |
Recent Litigation for PREZCOBIX
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| JANSSEN PRODUCTS, L.P. v. AMNEAL PHARMACEUTICALS, LLC | 2018-12-26 |
| JANSSEN PRODUCTS, L.P. v. DR. REDDY'S LABORATORIES, INC. | 2018-05-24 |
| JANSSEN PRODUCTS, L.P. v. AUROBINDO PHARMA LTD. | 2017-09-07 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Lupin Limited | 2015-04-09 |
Pharmacology for PREZCOBIX
Synonyms for PREZCOBIX
| Cobicistat / darunavir |
| Cobicistat and darunavir |
| Cobicistat mixture with darunavir |
| Darunavir / Cobicistat |
| S900006400 |
US Patents and Regulatory Information for PREZCOBIX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 PREZCOBIX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | Start Trial | Start Trial |
| Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | Start Trial | Start Trial |
| Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | Start Trial | Start Trial |
| Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PREZCOBIX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3112355 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2009135179 | Start Trial |
| Spain | 2362404 | Start Trial |
| Brazil | PI1008664 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PREZCOBIX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2487162 | CA 2017 00002 | Denmark | Start 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 |
| 2487166 | 59/2016 | Austria | Start 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 | 61/2016 | Austria | Start Trial | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSVBESONDERE DARUNAVIR-ETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 (MITTEILUNG) 20141121 |
| 2487163 | 93353 | Luxembourg | Start Trial | PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI ET ATAZANAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE SULFATE D'ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
