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PREZCOBIX Drug Profile
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» See Plans and PricingWhen do Prezcobix patents expire, and when can generic versions of Prezcobix launch?
Prezcobix is a drug marketed by Janssen Prods and is included in one NDA. There are four patents protecting this drug.
This drug has three hundred and eighteen patent family members in thirty-nine countries.
The generic ingredient in PREZCOBIX is cobicistat; darunavir. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; darunavir profile page.
US ANDA Litigation and Generic Entry Outlook for Prezcobix
Prezcobix was eligible for patent challenges on August 27, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 4, 2032. This may change due to patent challenges or generic licensing.
There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for PREZCOBIX
| International Patents: | 318 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| 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 |
Pharmacology for PREZCOBIX
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 | 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 | |||
| >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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PREZCOBIX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2546378 | Start Trial |
| European Patent Office | 2487162 | Start Trial |
| African Regional IP Organization (ARIPO) | 3250 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PREZCOBIX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0810209 | CA 2007 00017 | Denmark | Start Trial | PRODUCT NAME: DARUNAVIR OG ET FARMACEUTISK ACCEPTABELT SALT DERAF |
| 2487166 | 1790001-0 | Sweden | Start Trial | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061 20151123 |
| 2487163 | 2017002 | Norway | Start Trial | PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK; REG. NO/DATE: EU/1/15/1025 20150810 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
