Viewing data from:

VIRACEPT

NDA

NELFINAVIR MESYLATE | N021503 | AGOURON PHARMACEUTICALS LLC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain0 active DMFs3 inactive

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

GANES CHEMICALS INC PENNSVILLE DIVInactiveNELFINAVIR

DMF 121781996

AUROBINDO PHARMA LTDInactiveNELFINAVIR MESYLATE

DMF 184542005

MYLAN LABORATORIES LTDInactiveNELFINAVIR MESYLATE

DMF 185002005

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

Approval Letters

17 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 625MG BASE

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 30, 2003

No patent or exclusivity listings for this strength.