Atazanavir sulfate; cobicistat - Generic Drug Details

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What are the generic 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

Generic Entry Date for atazanavir sulfate; cobicistat^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Anatomical Therapeutic Chemical (ATC) Classes for atazanavir sulfate; cobicistat

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 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

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Glossary

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

Expired US Patents for atazanavir sulfate; cobicistat

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

International Patents for atazanavir sulfate; cobicistat

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Country	Patent Number	Title	Estimated Expiration
Cyprus	2017003		⤷ Sign Up
European Patent Office	2487161	Modulateurs de propriétés pharmacocinétiques d'agents thérapeutiques (Modulators of pharmacokinetic properties of therapeutics)	⤷ Sign Up
European Patent Office	3150586	MODULATEURS DE PROPRIÉTÉS PHARMACOCINÉTIQUES D'AGENTS THÉRAPEUTIQUES (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for atazanavir sulfate; cobicistat

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487166	300860	Netherlands	⤷ Sign Up	PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN TENOFOVIR-ALAFENAMIDE, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIR-ALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1061 20151123
3150586	132020000000055	Italy	⤷ Sign Up	PRODUCT NAME: COBICISTAT O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, DARUNAVIR O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO, E EMTRICITABINE O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO(SYMTUZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1225, 20170925
2049506	122015000092	Germany	⤷ Sign Up	PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.