INVIRASE Drug Patent Profile

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

Invirase is a drug marketed by Hoffmann La Roche and Hoffmann-la Roche and is included in two NDAs.

The generic ingredient in INVIRASE is saquinavir mesylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the saquinavir mesylate profile page.

Summary for INVIRASE

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	12
Patent Applications:	4,134
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for INVIRASE
What excipients (inactive ingredients) are in INVIRASE?	INVIRASE excipients list
DailyMed Link:	INVIRASE at DailyMed

See drug prices for INVIRASE

Recent Clinical Trials for INVIRASE

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

Sponsor	Phase
Hoffmann-La Roche	Phase 1
Hoffmann-La Roche	Phase 2
University of California, San Diego	Phase 2/Phase 3

See all INVIRASE clinical trials

Pharmacology for INVIRASE

Drug Class	Protease Inhibitor
Mechanism of Action	Cytochrome P450 3A Inhibitors HIV Protease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for INVIRASE

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

US Patents and Regulatory Information for INVIRASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hoffmann La Roche	INVIRASE	saquinavir mesylate	CAPSULE;ORAL	020628-001	Dec 6, 1995		DISCN	Yes	No
Hoffmann-la Roche	INVIRASE	saquinavir mesylate	TABLET;ORAL	021785-001	Dec 17, 2004		DISCN	Yes	No

Expired US Patents for INVIRASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	INVIRASE	saquinavir mesylate	CAPSULE;ORAL	020628-001	Dec 6, 1995
Hoffmann-la Roche	INVIRASE	saquinavir mesylate	TABLET;ORAL	021785-001	Dec 17, 2004

International Patents for INVIRASE

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

Country	Patent Number	Title	Estimated Expiration
Lithuania	3682	METHOD FOR PREPARING AMINO ACID DERIVATIVES AND PHARMACEUTHICAL COMPOSITIONS THEREOF
Zimbabwe	17490	AMINO ACID DERIVATIVES
United Kingdom	9026776
Finland	905983
Czech Republic	280558	Deriváty aminokyselin, způsob jejich výroby, jejich použití a léčiva na jejich bázi (DERIVATIVES OF AMINO ACIDS, PROCESS OF THEIR PREPARATION, THEIR USE AND MEDICAMENTS BASED THEREON)
Ireland	904453
Malawi	8890	AMINO ACID DERIVATIVES

Supplementary Protection Certificates for INVIRASE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0432695	96C0044	Belgium		PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
0432695	32/1996	Austria		PRODUCT NAME: SAQUINAVIR UND SEINE SAEUREADDITIONSSALZE, INSBESONDERE SAQUINAVIRMESYLAT; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
0034432	96C0048	Belgium		PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
0432695	C970013	Netherlands		PRODUCT NAME: SAQUINAVIR DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARD BAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/96/026/001 19961004