APTIVUS Drug Patent Profile

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.

Summary for APTIVUS

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	7
Patent Applications:	5,568
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for APTIVUS
What excipients (inactive ingredients) are in APTIVUS?	APTIVUS excipients list
DailyMed Link:	APTIVUS at DailyMed

See drug prices for APTIVUS

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

See all APTIVUS clinical trials

Pharmacology for APTIVUS

Drug Class	Protease Inhibitor
Mechanism of Action	HIV Protease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for APTIVUS

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

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
Boehringer Ingelheim	APTIVUS	tipranavir	SOLUTION;ORAL	022292-001	Jun 23, 2008		DISCN	Yes	No

Expired US Patents for APTIVUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	APTIVUS	tipranavir	SOLUTION;ORAL	022292-001	Jun 23, 2008
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	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

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

International Patents for APTIVUS

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

Country	Patent Number	Title	Estimated Expiration
Hungary	226114	SELF-EMULSIFYING FORMULATION FOR LIPOPHILIC COMPOUNDS
Hong Kong	1040625
European Patent Office	0999838	FORMULATION AUTOEMULSIFIANTE POUR COMPOSES LIPOPHILES (SELF-EMULSIFYING FORMULATION FOR LIPOPHILIC COMPOUNDS)
Colombia	5160321	NOVEDOSAS COMPOSICIONES DE TIPRANAVIR Y RITONAVIR
Slovenia	758327
Russian Federation	2202346	PHARMACEUTICAL COMPOSITION FOR ACID LIPOPHILIC COMPOUNDS IN FORM OF SELF-EMULSIFYING COMPOSITION
Hong Kong	1028879

Supplementary Protection Certificates for APTIVUS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0758327	SPC034/2005	Ireland		SPC034/2005: 20061023, EXPIRES: 20200503
0758327	PA2005008,C0758327	Lithuania		PRODUCT NAME: TIPRANAVIRUM; REGISTRATION NO/DATE: EU/1/05/315/001 20051025
0758327	PA2005008	Lithuania		PRODCT NAME: TIPRANAVIRUM; REGISTRATION NO/DATE: EU/1/05/315/001 20051025
0758327	CA 2005 00052	Denmark
0758327	C00758327/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0758327	SPC/GB06/009	United Kingdom		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	05C0047	France		PRODUCT NAME: TIPRANAVIR; REGISTRATION NO/DATE: EU/1/05/315/001 20051025