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FORTOVASE Drug 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. 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
Fortovase was eligible for patent challenges on December 31st, 1968.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 16th, 2020. This may change due to patent challenges or generic licensing.
Summary for FORTOVASE
| International Patents: | 40 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 39 |
| Clinical Trials: | 8 |
| Patent Applications: | 4,500 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | FORTOVASE at DailyMed |
Generic Entry Opportunity Date for FORTOVASE
Generic Entry Date for FORTOVASE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 |
| Hoffmann-La Roche | Phase 3 |
Synonyms for FORTOVASE
| (2S)-N-[(1S,2R)-3-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)-3,4,4a,5,6,7,8,8a-octahydro-1H-isoquinolin-2-yl]-1-benzyl-2-hydroxy-propyl]-2-(quinoline-2-carbonylamino)butanediamide |
| (2s)-N-[(2s,3r)-4-[(2s,3s,4as,8as)-3-(Tert-Butylcarbamoyl)-3,4,4a,5,6,7,8,8a-Octahydro-1h-Isoquinolin-2-Yl]-3-Hydroxy-1-Phenyl-Butan-2-Yl]-2-(Quinolin-2-Ylcarbonylamino)butanediamide |
| (2S)-N-[(2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)-3,4,4a,5,6,7,8,8a-octahydro-1H-isoquinolin-2-yl]-3-hydroxy-1-phenylbutan-2-yl]-2-(quinoline-2-carbonylamino)butanediamide |
| (2S)-N-[(2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)-decahydroisoquinolin-2-yl]-3-hydroxy-1-phenylbutan-2-yl]-2-(quinolin-2-ylformamido)butanediamide |
| (3S-(2(1R*(R*),2S*),3I,4athetav,8athetav))-N(sup 1)-(3-(3-(((1,1-Dimethylethyl)amino)carbonyl)octahydro-2(1H)-isoquinolinyl)-2-hydroxy-1-(phenylmethyl)propyl)-2-((2-quinolinylcarbonyl)amino)butanediamide |
| (S)-N-((IS)-I-((1R)-2-((3S,4aS,8aS)-3-(tert-Butylcarbamoyl)octahydro-2(1H)-isoquinolyl)-1-hydroxyethyl)phenethyl)-2-quinaldamidosuccinamide |
| (S)-N1-((2S,3R)-4-((3S,4aS,8aS)-3-(tert-butylcarbamoyl)octahydroisoquinolin-2(1H)-yl)-3-hydroxy-1-phenylbutan-2-yl)-2-(quinoline-2-carboxamido)succinamide |
| 127779-20-8 |
| 131176-13-1 |
| 149845-06-7 (monomethanesulfonate (salt)) |
| 1hxb |
| 2-[[2-methyl-3-(trifluoromethyl)phenyl]amino]pyridine-3-carboxylic acid |
| 24223-EP2269989A1 |
| 24223-EP2272516A2 |
| 24223-EP2272825A2 |
| 24223-EP2298761A1 |
| 24223-EP2298783A1 |
| 24223-EP2305640A2 |
| 24223-EP2305680A2 |
| 24223-EP2314590A1 |
| 2fgu |
| 2fgv |
| 779S208 |
| AB00514056 |
| ABP000344 |
| AC-26377 |
| AC1L9ATC |
| AKOS000280831 |
| AN-32602 |
| BC210734 |
| BDBM50213021 |
| BIDD:GT0323 |
| BIDD:PXR0010 |
| BPBio1_001373 |
| BRD-K09963420-066-03-4 |
| BSPBio_001248 |
| Butanediamide, N1-((1S,2R)-3-((3S,4aS,8aS)-3-(((1,1-dimethylethyl)amino)carbonyl)octahydro-2(1H)-isoquinolinyl)-2-hydroxy-1-(phenylmethyl)propyl)-2-((2-quinolinylcarbonyl)amino)-, (2S)- |
| Butanediamide, N1-(3-(3-(((1,1-dimethylethyl)amino)carbonyl)octahydro-2(1H)-isoquinolinyl)-2-hydroxy-1-(phenylmethyl)propyl)-2-((2-quinolinylcarbonyl)amino)-, (3S-(2(1R*(R*),2S*),3alpha,4aalpha,8aalpha))- |
| Butanediamide, N1-[(1S,2R)-3-[(3S,4aS,8aS)-3-[[(1,1-dimethylethyl)amino]carbonyl]octahydro-2(1H)-isoquinolinyl]-2-hydroxy-1-(phenylmethyl)propyl]-2-[(2-quinolinylcarbonyl)amino]-, (2S)- |
| C-23431 |
| CC-34367 |
| CHEBI:63621 |
| CHEMBL114 |
| CIS-N-TERT-BUTYL-DECAHYDRO-2-[2(R)-HYDROXY-4-PHENYL-3(S)-[[N-2-QUINOLYLCARBONYL-L-ASPARAGINYL]AMINO]BUTYL]-(4AS)-ISOQUINOLINE-3(S)-CARBOXAMIDE |
| CS-1180 |
| D00429 |
| DB01232 |
| DTXSID6044012 |
| Fortovase (TN) |
| Fortovase; SAQUINAVIR,RO 31-8959 |
| Fortovase(TM) |
| GTPL4813 |
| HMS2232L04 |
| HSDB 7161 |
| HY-17007 |
| Invirase |
| Invirase(TM)(monomesylate) |
| L3JE09KZ2F |
| LS-187081 |
| MLS001195635 |
| MLS001304735 |
| MRF-0000273 |
| 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 |
| 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 |
| 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 |
| N(1)-{(2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)octahydroisoquinolin-2(1H)-yl]-3-hydroxy-1-phenylbutan-2-yl}-N(2)-(quinolin-2-ylcarbonyl)-L-aspartamide |
| N~1~-{(2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)octahydroisoquinolin-2(1H)-yl]-3-hydroxy-1-phenylbutan-2-yl}-N~2~-(quinolin-2-ylcarbonyl)-L-aspartamide |
| N1-[(1S,2R)-3-[(3S,4aS,8aS)-3-[[(1,1-Dimethylethyl)amino]carbonyl]octahydro-2(1H)-isoquinolinyl]-2-hydroxy-1-(phenylmethyl)propyl]-2-[(2-quinolinylcarbonyl)amino]-butanediamide |
| NCGC00091469-02 |
| NP-SQV |
| NSC722663 |
| PLCG-SQV |
| Prestwick0_001114 |
| Prestwick1_001114 |
| Prestwick2_001114 |
| Prestwick3_001114 |
| QNC-ASN-HPH-DIQ-NTB |
| QWAXKHKRTORLEM-UGJKXSETSA-N |
| Ro 31 8959 |
| Ro 31-8959 |
| Ro 31-8959/000 |
| Ro 318959 |
| Ro-31-8959 |
| Ro-318959000 |
| ROC |
| saguinavir |
| SAQUINAVIR |
| Saquinavir (JAN/USP/INN) |
| Saquinavir [USAN:USP:INN:BAN] |
| Saquinavir-poly(lactide-co-glycolide) |
| Saquinavir/ |
| saquinavirmesylate(subjecttopatentfree) |
| SC-14020 |
| Sch 52852 |
| SCHEMBL6881 |
| SMR000469157 |
| SPBio_003114 |
| SQV |
| SQV-poly(lactide-co-glycolide) |
| UNII-L3JE09KZ2F |
| W-5153 |
| ZINC3914596 |
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 | Y | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FORTOVASE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Peru | 12402000 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0028942 | Start Trial |
| South Korea | 100446118 | Start Trial |
| Argentina | 020013 | Start Trial |
| Germany | 69919889 | Start Trial |
| Czech Republic | 299800 | Start Trial |
| China | 1172649 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FORTOVASE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0034432 | 96C0048 | 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 |
| 0432695 | 96C0044 | Belgium | Start Trial | PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
