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ATAZANAVIR SULFATE

ANDA

ATAZANAVIR SULFATE | A200626 | CIPLA LTD

4 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
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	—

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

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.

Products (4)

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#001 — EQ 100MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Aug 9, 2018

No patent or exclusivity listings for this strength.

#002 — EQ 150MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 9, 2018

#003 — EQ 200MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 9, 2018

#004 — EQ 300MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 9, 2018