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EVOTAZ Drug Profile

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

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

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.

Summary for EVOTAZ

US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	3
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EVOTAZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVOTAZ
DailyMed Link:	EVOTAZ at DailyMed

Generic Entry Opportunity 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.

Pharmacology for EVOTAZ

Drug Class	Protease Inhibitor Cytochrome P450 3A Inhibitor
Mechanism of Action	HIV Protease Inhibitors UGT1A1 Inhibitors UDP Glucuronosyltransferases Inhibitors Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A Inhibitors Cytochrome P450 2C8 Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 2D6 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Breast Cancer Resistance Protein Inhibitors

US Patents and Regulatory Information for EVOTAZ

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

Paragraph IV (Patent) Challenges for EVOTAZ

Drugname	Dosage	Strength	RLD	Date
	Tablets	300 mg/150 mg

International Patents for EVOTAZ

Country	Document Number	Estimated Expiration
Croatia	P20161371
South Korea	20110122729
China	103275033
Taiwan	I496778

Supplementary Protection Certificates for EVOTAZ

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
16/061	Ireland		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061 20151119
0861	Netherlands		PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN EN DARUNAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN. IN HET BIJZONDER DARUNAVIRETHANOLAAT; REGISTRATION NO/DATE: EU/1/14/967 20141121
0170003 00221	Estonia		PRODUCT NAME: DARUNAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/14/967 21.11.2014
90002-8	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REG. NO/DATE: EU/1/15/1025 20150715