Viewing data from:

LEXIVA

NDA

FOSAMPRENAVIR CALCIUM | N022116 | VIIV HEALTHCARE 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF3 inactive

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

MATRIX PHARMACORP PRIVATE LTDFOSAMPRENAVIR CALCIUM USP

DMF 255782011

LUPIN LTDInactiveFOSAMPRENAVIR CALCIUM

DMF 255692012

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveFOSAMPRENAVIR CALCIUM

DMF 256492012

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveFOSAMPRENAVIR CALCIUM

DMF 275932014

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

Approval Letters

16 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 50MG BASE/ML

RLD

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Jun 14, 2007

No patent or exclusivity listings for this strength.