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Last Updated: September 22, 2020

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Saquinavir - Generic Drug Details

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What are the generic sources for saquinavir and what is the scope of freedom to operate?

Saquinavir is the generic ingredient in two branded drugs marketed by Hoffmann La Roche and Hoffmann-la Roche, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Saquinavir has forty patent family members in thirty-four countries.

There is one drug master file entry for saquinavir.

Summary for saquinavir
International Patents:40
US Patents:1
Tradenames:2
Applicants:2
NDAs:3
Drug Master File Entries: 1
Bulk Api Vendors: 44
Clinical Trials: 92
Patent Applications: 4,849
Formulation / Manufacturing:see details
DailyMed Link:saquinavir at DailyMed
Recent Clinical Trials for saquinavir

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

SponsorPhase
Maimonides Medical CenterPhase 2
Temple UniversityPhase 4
Veloxis PharmaceuticalsPhase 4

See all saquinavir clinical trials

Medical Subject Heading (MeSH) Categories for saquinavir

US Patents and Regulatory Information for saquinavir

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   Start Trial   Start Trial   Start Trial
Hoffmann La Roche FORTOVASE saquinavir CAPSULE;ORAL 020828-001 Nov 7, 1997 DISCN Yes No   Start Trial   Start Trial   Start Trial
Hoffmann-la Roche INVIRASE saquinavir mesylate TABLET;ORAL 021785-001 Dec 17, 2004 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 saquinavir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche FORTOVASE saquinavir CAPSULE;ORAL 020828-001 Nov 7, 1997   Start Trial   Start Trial
Hoffmann La Roche FORTOVASE saquinavir CAPSULE;ORAL 020828-001 Nov 7, 1997   Start Trial   Start Trial
Hoffmann La Roche FORTOVASE saquinavir CAPSULE;ORAL 020828-001 Nov 7, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for saquinavir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0432695 96C0044 Belgium   Start Trial PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
0034432 96C0048 Belgium   Start Trial PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
0432695 32/1996 Austria   Start Trial PRODUCT NAME: SAQUINAVIR UND SEINE SAEUREADDITIONSSALZE, INSBESONDERE SAQUINAVIRMESYLAT; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
0432695 C970013 Netherlands   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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