Viewing data from:

REYATAZ

NDA

ATAZANAVIR SULFATE | N021567 | BRISTOL MYERS SQUIBB CO

4 strengths0 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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Bristol-Myers Squibb Company v. Apotex Inc. et al 1:2017cv01493 1 patentANDA 210400atazanavir sulfate	D. Del.	2017-10-24	Terminated 2018-02-14	—
Bristol-Myers Squibb Company v. Cipla USA, Inc. et al 1:2016cv00074 1 patentANDA 200626atazanavir sulfate	D. Del.	2016-02-11	Terminated 2016-08-05	—
Bristol-Myers Squibb Company et al v. Teva Pharmaceuticals USA Inc. 1:2010cv00264 2 patentsANDA 91673atazanavir bisulfate	D. Del.	2010-04-01	Terminated 2011-10-24	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Reyataz (2023)

Total Spending

$959K

Total Claims

530

Beneficiaries

Avg Cost/Unit

$40.47

Spending Trend

$4.3M(2019)→$2.3M(2020)→$1.7M(2021)→$1.3M(2022)→$959K(2023)

YoY Change:+0.9%

5yr CAGR:+0.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

37 letters from Drugs@FDA

Date	Submission	Document
Dec 6, 2024	SUPPL -49	View Letter (PDF)
Nov 8, 2023	SUPPL -48	View Letter (PDF)
May 10, 2023	SUPPL -47	View Letter (PDF)
Sep 25, 2020	SUPPL -44	View Letter (PDF)
Apr 20, 2018	SUPPL -42	View Letter (PDF)
Oct 23, 2017	SUPPL -41	View Letter (PDF)
May 25, 2017	SUPPL -40	View Letter (PDF)
Sep 20, 2016	SUPPL -39	View Letter (PDF)
Sep 28, 2015	SUPPL -38	View Letter (PDF)
Apr 1, 2015	SUPPL -37	View Letter (PDF)
Feb 27, 2015	SUPPL -36	View Letter (PDF)
Jun 3, 2014	SUPPL -35	View Letter (PDF)
Aug 20, 2013	SUPPL -33	View Letter (PDF)
Aug 20, 2013	SUPPL -32	View Letter (PDF)
Feb 4, 2013	SUPPL -31	View Letter (PDF)
Mar 16, 2012	SUPPL -28	View Letter (PDF)
Feb 23, 2012	SUPPL -27	View Letter (PDF)
Oct 19, 2011	SUPPL -26	View Letter (PDF)
Feb 10, 2011	SUPPL -25	View Letter (PDF)
Apr 29, 2010	SUPPL -23	View Letter (PDF)
Jan 28, 2010	SUPPL -22	View Letter (PDF)
Jan 25, 2010	SUPPL -19	View Letter (PDF)
Oct 2, 2008	SUPPL -17	View Letter (PDF)
Aug 20, 2008	SUPPL -16	View Letter (PDF)
Mar 28, 2008	SUPPL -15	View Letter (PDF)
Feb 22, 2008	SUPPL -18	View Letter (PDF)
Jan 9, 2008	SUPPL -14	View Letter (PDF)
Mar 31, 2007	SUPPL -12	View Letter (PDF)
Oct 23, 2006	SUPPL -9	View Letter (PDF)
Aug 14, 2006	SUPPL -11	View Letter (PDF)
Aug 14, 2006	SUPPL -8	View Letter (PDF)
Jan 30, 2006	SUPPL -7	View Letter (PDF)
Jul 21, 2005	SUPPL -5	View Letter (PDF)
Oct 8, 2004	SUPPL -4	View Letter (PDF)
Jul 7, 2004	SUPPL -2	View Letter (PDF)
Mar 19, 2004	SUPPL -1	View Letter (PDF)
Aug 6, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jun 20, 2003

No patent or exclusivity listings for this strength.

#002 — EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jun 20, 2003

#003 — EQ 200MG BASE

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jun 20, 2003

#004 — EQ 300MG BASE

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 16, 2006