TIPRANAVIR - Generic Drug Details

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
Aswan Heart Centre	N/A
Cairo University	N/A
Rockefeller University	Phase 4

See all TIPRANAVIR clinical trials

Pharmacology for TIPRANAVIR

Drug Class	Protease Inhibitor
Mechanism of Action	HIV Protease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TIPRANAVIR

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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
Boehringer Ingelheim	APTIVUS	tipranavir	CAPSULE;ORAL	021814-001	Jun 22, 2005		RX	Yes	Yes

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
Boehringer Ingelheim	APTIVUS	tipranavir	CAPSULE;ORAL	021814-001	Jun 22, 2005
Boehringer Ingelheim	APTIVUS	tipranavir	SOLUTION;ORAL	022292-001	Jun 23, 2008
Boehringer Ingelheim	APTIVUS	tipranavir	SOLUTION;ORAL	022292-001	Jun 23, 2008
Boehringer Ingelheim	APTIVUS	tipranavir	SOLUTION;ORAL	022292-001	Jun 23, 2008
Boehringer Ingelheim	APTIVUS	tipranavir	CAPSULE;ORAL	021814-001	Jun 22, 2005

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