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.
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Summary for APTIVUS
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 7 |
Patent Applications: | 5,251 |
Drug Prices: | Drug price information for APTIVUS |
What excipients (inactive ingredients) are in APTIVUS? | APTIVUS excipients list |
DailyMed Link: | APTIVUS at DailyMed |
Recent Clinical Trials for APTIVUS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Boehringer Ingelheim | Phase 3 |
University of California, San Diego | Phase 2/Phase 3 |
National Institutes of Health (NIH) | Phase 2/Phase 3 |
Pharmacology for APTIVUS
Drug Class | Protease Inhibitor |
Mechanism of Action | HIV 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Boehringer Ingelheim | APTIVUS | tipranavir | SOLUTION;ORAL | 022292-001 | Jun 23, 2008 | DISCN | Yes | No | ⤷ 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 APTIVUS
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 | 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 |
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 |
>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 |
---|---|---|---|
Czech Republic | 9603172 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 9530670 | ⤷ Sign Up | |
Israel | 113567 | PYRAN-2-ONE AND 5,6-DIHYDROPYRAN-2-ONE DERIVATIVES USEFUL IN TREATING RETROVIRAL INFECTIONS | ⤷ Sign Up |
Spain | 2219895 | ⤷ Sign Up | |
Hungary | 225160 | SELF-EMULSIFYING FORMULATION FOR LIPOPHILIC COMPOUNDS | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for APTIVUS
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0758327 | 300216 | Netherlands | ⤷ Sign Up | 300216, 20150504, EXPIRES: 20200503 |
0758327 | PA2005008 | Lithuania | ⤷ Sign Up | PRODCT NAME: TIPRANAVIRUM; REGISTRATION NO/DATE: EU/1/05/315/001 20051025 |
0758327 | C00758327/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH |
0758327 | C300216 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TIPRANAVIR, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/05/315/001 20051025 |
0758327 | PA2005008,C0758327 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TIPRANAVIRUM; REGISTRATION NO/DATE: EU/1/05/315/001 20051025 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |