Details for New Drug Application (NDA): 206353

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NDA 206353 describes EVOTAZ, which is a drug marketed by Bristol and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EVOTAZ profile page.

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 206353

Tradename:	EVOTAZ
Applicant:	Bristol
Ingredient:	atazanavir sulfate; cobicistat
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206353

Generic Entry Date for 206353^: ⤷ 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 NDA: 206353

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

Suppliers and Packaging for NDA: 206353

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353	NDA	E.R. Squibb & Sons, L.L.C.	0003-3641	0003-3641-11	30 TABLET in 1 BOTTLE (0003-3641-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 300MG BASE;150MG
Approval Date:	Jan 29, 2015	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Oct 6, 2032	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Sep 3, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE

Expired US Patents for NDA 206353

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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

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