FORTOVASE Drug Patent Profile
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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.
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.
Summary for FORTOVASE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 57 |
| Clinical Trials: | 8 |
| Patent Applications: | 5,400 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for FORTOVASE
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 | ⤷ 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 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 | ⤷ 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 FORTOVASE
| 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 |
International Patents for FORTOVASE
See the table below for patents covering FORTOVASE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 173630 | DERIVADOS DE AMINOACIDO, PROCEDIMIENTO PARA SU PREPARACION Y SU PREPARACION Y MEDICAMENTO QUE LOS CONTIENE | ⤷ Try a Trial |
| New Zealand | 311646 | Pharmaceutical composition comprising a proteinase inhibitor and a monoglyceride | ⤷ Try a Trial |
| India | 172553 | Process for the manufacture of N-tert.butyl-decahydro-2-[2(R)-hydroxy-4-phenyl-3(S)-[(N-(2-quinolylcarbonyl)-L-asparaginyl]amino]butyl-(4as, 8as)-isoquinoline-3(S)-carboxamide | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FORTOVASE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0432695 | 96C0044 | Belgium | ⤷ Try a Trial | PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004 |
| 0432695 | 32/1996 | Austria | ⤷ Try a Trial | PRODUCT NAME: SAQUINAVIR UND SEINE SAEUREADDITIONSSALZE, INSBESONDERE SAQUINAVIRMESYLAT; REGISTRATION NO/DATE: EU/1/96/026/001 19961004 |
| 0034432 | 96C0048 | Belgium | ⤷ Try a Trial | PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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