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Last Updated: May 27, 2024

TIPRANAVIR - Generic Drug Details


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What are the generic sources for tipranavir and what is the scope of freedom to operate?

Tipranavir is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for tipranavir. One supplier is listed for this compound.

Summary for TIPRANAVIR
Recent Clinical Trials for TIPRANAVIR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Aswan Heart CentreN/A
Cairo UniversityN/A
Rockefeller UniversityPhase 4

See all TIPRANAVIR clinical trials

Pharmacology for TIPRANAVIR
Drug ClassProtease Inhibitor
Mechanism of ActionHIV Protease Inhibitors

US Patents and Regulatory Information for TIPRANAVIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim APTIVUS tipranavir SOLUTION;ORAL 022292-001 Jun 23, 2008 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim APTIVUS tipranavir CAPSULE;ORAL 021814-001 Jun 22, 2005 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TIPRANAVIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim APTIVUS tipranavir CAPSULE;ORAL 021814-001 Jun 22, 2005 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim APTIVUS tipranavir CAPSULE;ORAL 021814-001 Jun 22, 2005 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim APTIVUS tipranavir SOLUTION;ORAL 022292-001 Jun 23, 2008 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim APTIVUS tipranavir SOLUTION;ORAL 022292-001 Jun 23, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for TIPRANAVIR

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Boehringer Ingelheim International GmbH Aptivus tipranavir EMEA/H/C/000631
Aptivus, co-administered with low-dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pretreated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors.Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.This indication is based on the results of two phase-III studies, performed in highly pretreated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase-II study investigating pharmacokinetics, safety and efficacy of Aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years.In deciding to initiate treatment with Aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Aptivus. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to Aptivus, co-administered with low-dose ritonavir.
Authorised no no no 2005-10-25
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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