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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. 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: | 45 |
| 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
| Sponsor | Phase |
|---|---|
| Maimonides Medical Center | Phase 2 |
| Temple University | Phase 4 |
| Veloxis Pharmaceuticals | Phase 4 |
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 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| 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 | ||||
| >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 |
International Patents for saquinavir
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2350943 | Start Trial |
| Denmark | 1131037 | Start Trial |
| China | 1172649 | Start Trial |
| Poland | 348350 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for saquinavir
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 0432695 | 96C0044 | 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 |
| 0034432 | 96C0048 | Belgium | Start Trial | PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
