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Last Updated: March 28, 2024

Saquinavir - Generic Drug Details


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What are the generic drug 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. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for saquinavir.

Recent Clinical Trials for saquinavir

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

SponsorPhase
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaPhase 1
Fundacio Lluita Contra la SIDAPhase 1
University of WashingtonPhase 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 TABLET;ORAL 021785-001 Dec 17, 2004 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche INVIRASE saquinavir mesylate CAPSULE;ORAL 020628-001 Dec 6, 1995 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche FORTOVASE saquinavir CAPSULE;ORAL 020828-001 Nov 7, 1997 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche FORTOVASE saquinavir CAPSULE;ORAL 020828-001 Nov 7, 1997 ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche FORTOVASE saquinavir CAPSULE;ORAL 020828-001 Nov 7, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for saquinavir

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Roche Registration GmbH Invirase saquinavir EMEA/H/C/000113
Invirase is indicated for the treatment of HIV-1-infected adult patients. Invirase should only be given in combination with ritonavir and other antiretroviral medicinal products.
Withdrawn no no no 1996-10-03
Roche Registration Ltd. Fortovase saquinavir EMEA/H/C/000178
Fortovase is indicated for treatment of HIV-1 infected adult patients. Fortovase should only be given in combination with ritonavir and other antiretroviral medicinal products (see section 4.2).
Withdrawn no no no 1998-08-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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