Saquinavir - Generic Drug Details
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What are the generic drug sources for saquinavir and what is the scope of patent protection?
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.
Summary for saquinavir
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 3 |
| Drug Master File Entries: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 57 |
| Clinical Trials: | 89 |
| Patent Applications: | 7,726 |
| DailyMed Link: | saquinavir at DailyMed |
Recent Clinical Trials for saquinavir
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fundacio Lluita Contra la SIDA | Phase 1 |
| Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | Phase 1 |
| University of Washington | Phase 4 |
Medical Subject Heading (MeSH) Categories for saquinavir
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hoffmann-la Roche | INVIRASE | saquinavir mesylate | TABLET;ORAL | 021785-001 | Dec 17, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hoffmann La Roche | FORTOVASE | saquinavir | CAPSULE;ORAL | 020828-001 | Nov 7, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Hoffmann La Roche | FORTOVASE | saquinavir | CAPSULE;ORAL | 020828-001 | Nov 7, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Hoffmann La Roche | FORTOVASE | saquinavir | CAPSULE;ORAL | 020828-001 | Nov 7, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
