ATAZANAVIR SULFATE; COBICISTAT - Generic Drug Details

What are the generic drug sources for atazanavir sulfate; cobicistat and what is the scope of patent protection?

Atazanavir sulfate; cobicistat is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Atazanavir sulfate; cobicistat has two hundred and ninety-five patent family members in forty countries.

One supplier is listed for this compound.

Summary for ATAZANAVIR SULFATE; COBICISTAT

International Patents:	295
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ATAZANAVIR SULFATE; COBICISTAT
DailyMed Link:	ATAZANAVIR SULFATE; COBICISTAT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ATAZANAVIR SULFATE; COBICISTAT

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 ATAZANAVIR SULFATE; COBICISTAT

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

Paragraph IV (Patent) Challenges for ATAZANAVIR SULFATE; COBICISTAT

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 ATAZANAVIR SULFATE; COBICISTAT

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
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015		RX	Yes	Yes			Y	Y

Expired US Patents for ATAZANAVIR SULFATE; COBICISTAT

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 ATAZANAVIR SULFATE; COBICISTAT

Country	Patent Number	Title	Estimated Expiration
Japan	2014221845	併用治療のための錠剤 (TABLETS FOR COMBINATION THERAPY)
Norway	345343
South Korea	20160093100	조합 요법용 정제 (TABLETS FOR COMBINATION THERAPY)
Spain	2553897
Serbia	55459	MODULATORI FARMAKOKINETIČKIH SVOJSTAVA LEKOVA (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS)

Supplementary Protection Certificates for ATAZANAVIR SULFATE; COBICISTAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3150586	2090020-5	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEBTABLE SALT OR SOLVATE THEREOF; REG. NO/DATE: EU/1/17/1225 20170925
2487162	PA2016040,C2487162	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS IR DARUNAVIRAS,ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
2487166	2017003	Norway		PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV OG TENOFOVIR ALAFENAMID ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV, SPESIELT TENOFOVIR ALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061 20151209
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	SPC/GB15/067	United Kingdom		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/830/001 20130527; UK EU/1/13/830/002 20130527