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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

APTIVUS

NDANot in Orange Book

TIPRANAVIR | N021822 | BOEHRINGER INGELHEIM

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.

CATALENT PHARMA SOLUTIONS LLCInactiveTIPRANAVIR CAPSULES 250 MG (IMPRINTED)

DMF 177832004

RP SCHERER GMBH AND CO KGInactiveTIPRANAVIR CAPSULES 250 MG (IMPRINT)

DMF 207072007

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 26, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/ML

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SOLUTION; ORAL | Approved: Jun. 23, 2008

No patent or exclusivity listings for this strength.