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EVOTAZ Drug Patent Profile

Which patents cover Evotaz, and when can generic versions of Evotaz launch?

Evotaz is a drug marketed by Bristol and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and ninety-five patent family members in forty countries.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atazanavir sulfate; cobicistat profile page.

DrugPatentWatch^® Generic Entry Outlook for Evotaz

Evotaz 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 eight 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 EVOTAZ

International Patents:	295
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Patent Applications:	98
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EVOTAZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVOTAZ
What excipients (inactive ingredients) are in EVOTAZ?	EVOTAZ excipients list
DailyMed Link:	EVOTAZ at DailyMed

See drug prices for EVOTAZ

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EVOTAZ

NDA:

206353

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 EVOTAZ

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Gilead Sciences	Phase 3
Bristol-Myers Squibb	Phase 1
St Stephens Aids Trust	Phase 1

See all EVOTAZ clinical trials

Pharmacology for EVOTAZ

Drug Class

Cytochrome P450 3A Inhibitor Protease Inhibitor

Mechanism of Action

Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors UDP Glucuronosyltransferases Inhibitors UGT1A1 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EVOTAZ

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 EVOTAZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EVOTAZ	Tablets	atazanavir sulfate; cobicistat	300 mg/150 mg	206353	1	2017-09-13

US Patents and Regulatory Information for EVOTAZ

EVOTAZ is protected by two 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 EVOTAZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015		RX	Yes	Yes			Y	Y
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015		RX	Yes	Yes			Y

Expired US Patents for EVOTAZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015

International Patents for EVOTAZ

When does loss-of-exclusivity occur for EVOTAZ?

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 EVOTAZ around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	E029866
Portugal	3150586
Eurasian Patent Organization	025845	МОДУЛЯТОРЫ ФАРМАКОКИНЕТИЧЕСКИХ СВОЙСТВ ЛЕКАРСТВЕННЫХ СРЕДСТВ (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS)
China	1319587
Serbia	55195	MODULATORI FARMAKOKINETIČKIH SVOJSTAVA TERAPEUTIKA (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS)
Denmark	2487162
Israel	126381	HETEROCYCLIC AZAHEXANE DERIVATIVES AND ANTIVIRAL COMPOSITIONS CONTAINING THEM

Supplementary Protection Certificates for EVOTAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	1590060-8	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF
2487163	2017002	Norway		PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK; REG. NO/DATE: EU/1/15/1025 20150810
2487163	1790002-8	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/15/1025, 2015-07-15
2487162	2016C/068	Belgium		PRODUCT NAME: COBICISTAT ET DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967 20141121
2487166	59/2016	Austria		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
2049506	C02049506/01	Switzerland		PRODUCT NAME: COBICISTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62673 18.10.2013
3150586	CA 2020 00021	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIR ETHANOLAT, OG EMTRICITABIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/17/1225 20170925