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
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 68 |
Patent Applications: | 7,080 |
What excipients (inactive ingredients) are in TIPRANAVIR? | TIPRANAVIR excipients list |
DailyMed Link: | TIPRANAVIR at DailyMed |
Recent Clinical Trials for TIPRANAVIR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Cairo University | N/A |
Aswan Heart Centre | N/A |
Rockefeller University | Phase 4 |
Pharmacology for TIPRANAVIR
Drug Class | Protease Inhibitor |
Mechanism of Action | HIV Protease Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for TIPRANAVIR
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 | CAPSULE;ORAL | 021814-001 | Jun 22, 2005 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Boehringer Ingelheim | APTIVUS | tipranavir | SOLUTION;ORAL | 022292-001 | Jun 23, 2008 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 | SOLUTION;ORAL | 022292-001 | Jun 23, 2008 | ⤷ Subscribe | ⤷ Subscribe |
Boehringer Ingelheim | APTIVUS | tipranavir | CAPSULE;ORAL | 021814-001 | Jun 22, 2005 | ⤷ Subscribe | ⤷ Subscribe |
Boehringer Ingelheim | APTIVUS | tipranavir | SOLUTION;ORAL | 022292-001 | Jun 23, 2008 | ⤷ Subscribe | ⤷ Subscribe |
Boehringer Ingelheim | APTIVUS | tipranavir | SOLUTION;ORAL | 022292-001 | Jun 23, 2008 | ⤷ Subscribe | ⤷ Subscribe |
Boehringer Ingelheim | APTIVUS | tipranavir | CAPSULE;ORAL | 021814-001 | Jun 22, 2005 | ⤷ Subscribe | ⤷ Subscribe |
>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 |
TIPRANAVIR Market Analysis and Financial Projection Experimental
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