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Generated: January 22, 2019

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Details for New Drug Application (NDA): 021814

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NDA 021814 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 021814
Applicant:Boehringer Ingelheim
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021814
Generic Entry Date for 021814*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021814
Mechanism of ActionHIV Protease Inhibitors
Suppliers and Packaging for NDA: 021814
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
APTIVUS tipranavir CAPSULE;ORAL 021814 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0003 0597-0003-02 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0597-0003-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Jun 22, 2005TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 22, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Apr 29, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Jan 27, 2019Product Flag?Substance Flag?Delist Request?Y

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