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Details for New Drug Application (NDA): 022292

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NDA 022292 describes APTIVUS, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the APTIVUS profile page.

The generic ingredient in APTIVUS is tipranavir. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tipranavir profile page.

Summary for NDA: 022292

Tradename:
APTIVUS
Applicant:
Boehringer Ingelheim
Ingredient:
tipranavir
Patents:2
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 022292

Mechanism of ActionHIV Protease Inhibitors

Suppliers and Packaging for NDA: 022292

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
APTIVUS
tipranavir
SOLUTION;ORAL 022292 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0002 0597-0002-01 1 BOTTLE, GLASS in 1 CARTON (0597-0002-01) > 95 mL in 1 BOTTLE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/ML
Approval Date:Jun 23, 2008TE:RLD:Yes
Patent:5,852,195*PEDPatent Expiration:Dec 22, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:6,147,095*PEDPatent Expiration:Apr 29, 2020Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 022292

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
APTIVUS
tipranavir
SOLUTION;ORAL022292-001Jun 23, 20086,169,181*PED► subscribe
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