Viewing data from:

REYATAZ

NDA

ATAZANAVIR SULFATE | N206352 | BRISTOL MYERS SQUIBB CO

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition From Lachman Consultant Services Inc FDA-2014-P-0980 · 4 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA determine whether REYATAZ (atazanavir sulfate) Capsules, 100 mg, approved under NDA 21-567, was voluntarily withdrawn from the market for safety or efficacy reasons rather than commercial reasons, in	505(q)	2014-07-11	Denied	Lachman Consultant Services Inc

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

148 trials from ClinicalTrials.gov, 122 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings NCT00084136	Phase 4	Completed	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	1,571	2005-05 → 2010-05
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women NCT00869960	Phase 4	Completed	University of Alabama at Birmingham	24	2009-03 → 2010-12
Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome NCT00135356	Phase 4	Completed	Bristol-Myers Squibb	219	2005-07 → 2008-06
DDI HV (ATV - Merck)NCT00518297	Phase 1	Completed	Bristol-Myers Squibb	22	2007-08 → 2007-12
Raltegravir and Atazanavir Dosing Strategy Study NCT00874523	Phase 3	Completed	Kirby Institute	26	2009-07 → 2011-07
MARCH Renal Substudy NCT01637259	Phase 4	Completed	Kirby Institute	76	2012-06 → 2015-12
Atazanavir and Endothelial Function in Older HIV Patients NCT03019783	Phase 2/3	Completed	Brigham and Women's Hospital	60	2011-12 → 2016-06
Efficacy and Safety Study of Darunavir for the Treatment of HIV/AIDS NCT02155101	Phase 3	Completed	University of Liverpool	120	2014-05 → 2016-07
Metabolic Effects of Switching Kaletra to Boosted Reyataz NCT00413153	N/A	Completed	Massachusetts General Hospital	15	2006-05 → 2008-12
Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada NCT00528060	Phase 2	Completed	French National Agency for Research on AIDS and Viral Hepatitis	35	2008-01 → 2008-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$169.19

Highest Price

$227.16

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00003-3638-10REYATAZ 50MG POWDER PACKET 30'S	$227.16	FSS	Bristol-Myers Squibb Company	04/30/2029
00003-3638-10REYATAZ 50MG POWDER PACKET 30'S	$169.19	Big4	Bristol-Myers Squibb Company	04/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain15 active DMFs7 inactive

14 active API suppliers hold Drug Master Files for this ingredient.

EMCURE PHARMACEUTICALS LTDATAZANAVIR SULFATE USP

DMF 198562006

MATRIX PHARMACORP PRIVATE LTDATAZANAVIR SULFATE

DMF 204192007

OLON SPAATAZANAVIR SULFATE

DMF 205592007

APITORIA PHARMA PRIVATE LTDATAZANAVIR SULFATE USP (NON-STERILE DRUG SUBSTANCE)

DMF 255172011

HETERO LABS LTDATAZANAVIR SULFATE

DMF 255672011

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDATAZANAVIR SULFATE

DMF 266722012

SCINOPHARM TAIWAN LTDATAZANAVIR SULFATE

DMF 275622018

MATRIX PHARMACORP PRIVATE LTDATAZANAVIR SULFATE (PROCESS-II)

DMF 286352014

MSN PHARMACHEM PRIVATE LTDATAZANAVIR SULFATE USP [ROUTE CODE "AQ"]

DMF 291342015

MACLEODS PHARMACEUTICALS LTDATAZANAVIR SULFATE

DMF 296952015

RAKS PHARMA PVT LTDATAZANAVIR SULFATE

DMF 298522015

LAURUS LABS LTDATAZANAVIR SULFATE

DMF 309342016

SUN PHARMACEUTICAL INDUSTRIES LTDATAZANAVIR SULFATE

DMF 312292017

GRANULES INDIA LTDATAZANAVIR SULFATE

DMF 322592017

CHROMO LABORATORIES INDIA PRIVATE LTDATAZANAVIR SULFATE USP

DMF 335852021

LUPIN LTDInactiveATAZANAVIR SULFATE

DMF 236112010

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveATAZANAVIR SULFATE

DMF 249702011

ASYMCHEM LIFE SCIENCE TIANJIN CO LTDInactiveATAZANAVIR SULFATE

DMF 276322013

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveATAZANAVIR SULFATE

DMF 278762013

SIGNA SA DE CVInactiveATAZANAVIR SULFATE

DMF 285652015

LUPIN LTDInactiveATAZANAVIR SULFATE (PROCESS B)

DMF 291592015

VIWIT PHARMACEUTICAL CO LTDInactiveATAZANAVIR SULFATE

DMF 292122015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Dec 6, 2024	SUPPL -11	View Letter (PDF)
Nov 8, 2023	SUPPL -10	View Letter (PDF)
Sep 25, 2020	SUPPL -8	View Letter (PDF)
Apr 20, 2018	SUPPL -7	View Letter (PDF)
Oct 23, 2017	SUPPL -6	View Letter (PDF)
May 25, 2017	SUPPL -5	View Letter (PDF)
Sep 20, 2016	SUPPL -4	View Letter (PDF)
Sep 28, 2015	SUPPL -3	View Letter (PDF)
Apr 1, 2015	SUPPL -2	View Letter (PDF)
Jun 3, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 50MG BASE/PACKET

RLD

0 patents0 exclusivities▴

POWDER;ORAL | Approved: Jun 2, 2014

No patent or exclusivity listings for this strength.