DrugPatentWatch Database Preview
FORTOVASE Drug Profile
» See Plans and Pricing
When do Fortovase patents expire, and when can generic versions of Fortovase launch?
Fortovase is a drug marketed by Hoffmann La Roche and is included in one NDA. There is one patent protecting this drug.
This drug has forty patent family members in thirty-four countries.
The generic ingredient in FORTOVASE is saquinavir. There is one drug master file entry for this compound. Additional details are available on the saquinavir profile page.
US ANDA Litigation and Generic Entry Outlook for Fortovase
Indicators of Generic Entry
Summary for FORTOVASE
| International Patents: | 40 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 45 |
| Clinical Trials: | 8 |
| Patent Applications: | 4,221 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | FORTOVASE at DailyMed |
Recent Clinical Trials for FORTOVASE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Saint Michael's Medical Center | Phase 3 |
| Boehringer Ingelheim | Phase 1 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 |
US Patents and Regulatory Information for FORTOVASE
| 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 | 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 FORTOVASE
| 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 FORTOVASE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 288201 | Start Trial |
| China | 1138983 | Start Trial |
| China | 1034805 | Start Trial |
| Slovakia | 576590 | Start Trial |
| Spain | 2072959 | Start Trial |
| Morocco | 26761 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FORTOVASE
| 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 | 32/1996 | Austria | Start Trial | PRODUCT NAME: SAQUINAVIR UND SEINE SAEUREADDITIONSSALZE, INSBESONDERE SAQUINAVIRMESYLAT; 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 |
| 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 |
