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CRIXIVAN

NDA

INDINAVIR SULFATE | N020685 | MERCK SHARP AND DOHME CORP

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

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain0 active DMFs2 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MYLAN LABORATORIES LTDInactiveINDINAVIR SULFATE USP

DMF 184952005

AUROBINDO PHARMA LTDInactiveINDINAVIR SULFATE USP (NON-STERILE DRUG SUBSTANCE)

DMF 198512006

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

Approval Letters

24 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 400MG BASE

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Mar 13, 1996

No patent or exclusivity listings for this strength.

#003 — EQ 200MG BASE

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Mar 13, 1996

#005 — EQ 333MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 17, 1998

#006 — EQ 100MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 19, 2000