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EVOTAZ Drug Profile

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Which patents cover Evotaz, and what generic alternatives are available?

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.

This drug has three hundred and seven patent family members in fifty-one countries.

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

Summary for EVOTAZ

International Patents:	307
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
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
Prior Art and Litigation Support	Order Prior Art and Litigation support 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

Synonyms for EVOTAZ

Atazanavir / cobicistat

Atazanavir and cobicistat

Atazanavir mixture with cobicistat

Cobicistat / Atazanavir

S900006860

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

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	Patent Number	Estimated Expiration
Spain	2603645
Eurasian Patent Organization	030123
Denmark	2393485
South Korea	20090122261
Ukraine	97112
China	102307573
Eurasian Patent Organization	019893

Supplementary Protection Certificates for EVOTAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487166	1790001-0	Sweden		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
2487162	2016/063	Ireland		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE; REGISTRATION NO/DATE: EU/1/14/967 20141119
2487166	122016000104	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND TENOFOVIRALAFENAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2487163	300859	Netherlands		PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN ATAZANAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER ATAZANAVIRSULFAAT; REGISTRATION NO/DATE: EU/1/15/1025 20150715
2049506	PA2015040	Lithuania		PRODUCT NAME: COBICISTATUM; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
2487162	122016000103	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 20141119
2487166	2016/061	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