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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 NDA: 021814

Tradename:
APTIVUS
Applicant:
Boehringer Ingelheim
Ingredient:
tipranavir
Patents:3
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

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 1 BOTTLE, PLASTIC in 1 CARTON (0597-0003-02) > 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Jun 22, 2005TE: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
Patent:6,231,887*PEDPatent Expiration:Jan 27, 2019Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021814

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
APTIVUS
tipranavir
CAPSULE;ORAL021814-001Jun 22, 20056,169,181*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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