PREZCOBIX Drug Patent Profile

When 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 and one Paragraph IV challenge.

This drug has three hundred and thirty-four 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.

DrugPatentWatch^® 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 6, 2032. This may change due to patent challenges or generic licensing.

There have been ten 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:	334
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	2
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PREZCOBIX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREZCOBIX
What excipients (inactive ingredients) are in PREZCOBIX?	PREZCOBIX excipients list
DailyMed Link:	PREZCOBIX at DailyMed

See drug prices for PREZCOBIX

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for PREZCOBIX

NDA:

205395

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
Janssen Scientific Affairs, LLC	Phase 2/Phase 3
Stanford University	Phase 2/Phase 3

See all PREZCOBIX clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for PREZCOBIX

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

V03AX	Other therapeutic products
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for PREZCOBIX

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 PREZCOBIX

PREZCOBIX is protected by five US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting 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			Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes					Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes			Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes					Y

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
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015

International Patents for PREZCOBIX

When does loss-of-exclusivity occur for PREZCOBIX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Peru

Poland

Portugal

San Marino

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PREZCOBIX around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101636221
Japan	4864320
China	104940937	The use of solid carrier particles to improve the processability of a pharmaceutical agent
Luxembourg	C00156

Supplementary Protection Certificates for PREZCOBIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	60/2016	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715
2487166	PA2016038	Lithuania		PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2487163	122016000120	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCHES AKZEPTABLES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1025 20150713
0810209	2007/024	Ireland