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Last Updated: March 19, 2024

APTIVUS Drug Patent Profile


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Which patents cover Aptivus, and when can generic versions of Aptivus launch?

Aptivus is a drug marketed by Boehringer Ingelheim and is included in two NDAs.

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.

Drug patent expirations by year for APTIVUS
Drug Prices for APTIVUS

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Recent Clinical Trials for APTIVUS

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

SponsorPhase
Boehringer IngelheimPhase 3
National Institute of Mental Health (NIMH)Phase 2/Phase 3
University of California, San DiegoPhase 2/Phase 3

See all APTIVUS clinical trials

Pharmacology for APTIVUS
Drug ClassProtease Inhibitor
Mechanism of ActionHIV Protease Inhibitors

US Patents and Regulatory Information for APTIVUS

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 CAPSULE;ORAL 021814-001 Jun 22, 2005 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim APTIVUS tipranavir SOLUTION;ORAL 022292-001 Jun 23, 2008 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 APTIVUS

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

EU/EMA Drug Approvals for APTIVUS

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

International Patents for APTIVUS

See the table below for patents covering APTIVUS around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 9530670 ⤷  Try a Trial
Hungary 0003292 ⤷  Try a Trial
Norway 20000465 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9906043 ⤷  Try a Trial
Japan 2010070562 SELF-EMULSIFYING FORMULATION FOR LIPOPHILIC COMPOUND ⤷  Try a Trial
Japan H09512821 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for APTIVUS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0758327 C300216 Netherlands ⤷  Try a Trial PRODUCT NAME: TIPRANAVIR, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/05/315/001 20051025
0758327 SPC/GB06/009 United Kingdom ⤷  Try a Trial PRODUCT NAME: (R-(R*,R*))-N-(3-(1-(5,6-DIHYDRO-4-HYDROXY-2-OXO-6-(2-PHENYLETHYL)-6-PROPYL-2H-PYRAN-3-YL)PROPYL)PHENYL)-5-(TRIFLUOROMETHYL)-2-PYRIDINESULFONAMIDE OR A PHARMACEUTICAL SALT THEREOF = (TIPRANAVIR OR A PHARMACEUTICAL SALT THEREOF); REGISTERED: CH 57330 20050825; UK EU/1/05/315/001 20051025
0758327 CA 2005 00052 Denmark ⤷  Try a Trial
0758327 PA2005008 Lithuania ⤷  Try a Trial PRODCT NAME: TIPRANAVIRUM; REGISTRATION NO/DATE: EU/1/05/315/001 20051025
0758327 91220 Luxembourg ⤷  Try a Trial 91220, EXPIRES: 20200504
0758327 PA2005008,C0758327 Lithuania ⤷  Try a Trial PRODUCT NAME: TIPRANAVIRUM; REGISTRATION NO/DATE: EU/1/05/315/001 20051025
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.