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RYANODEX Drug Profile
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Which patents cover Ryanodex, and what generic alternatives are available?
Ryanodex is a drug marketed by Eagle Pharms and is included in one NDA. There are five patents protecting this drug.
This drug has eight patent family members in five countries.
The generic ingredient in RYANODEX is dantrolene sodium. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dantrolene sodium profile page.
US ANDA Litigation and Generic Entry Outlook for Ryanodex
A generic version of RYANODEX was approved as dantrolene sodium by IMPAX LABS on January 20th, 2020.
Summary for RYANODEX
| International Patents: | 8 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 53 |
| Clinical Trials: | 3 |
| Patent Applications: | 2,368 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RYANODEX |
| DailyMed Link: | RYANODEX at DailyMed |
Recent Clinical Trials for RYANODEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Eagle Pharmaceuticals, Inc. | Phase 3 |
| Eagle Pharmaceuticals, Inc. | Phase 2 |
| Quintiles, Inc. | Phase 2 |
Pharmacology for RYANODEX
| Drug Class | Skeletal Muscle Relaxant |
| Physiological Effect | Decreased Striated Muscle Contraction Decreased Striated Muscle Tone |
Synonyms for RYANODEX
| 1-(((5-(4-Nitrophenyl)-2-furanyl)methylene)amino)-2,4-imidazolidinedione |
| 1-(((E)-[5-(4-Nitrophenyl)-2-furyl]methylidene)amino)-2,4-imidazolidinedione # |
| 1-((5-(4-Nitrophenyl)furfurylidene)amino)imidazolidine-2,4-dione, sodium salt |
| 1-((5-(p-Nitrophenyl)furfurylidene)amino)hydantoin |
| 1-((5-(p-Nitrophenyl)furfurylidene)amino)hydantoin sodium |
| 1-((5-(p-Nitrophenyl)furfurylidene)amino)hydantoin sodium salt hydrate |
| 1-({(1E)-[5-(4-nitrophenyl)furan-2-yl]methylidene}amino)imidazolidine-2,4-dione |
| 1-({[5-(4-nitrophenyl)furan-2-yl]methylidene}amino)imidazolidine-2,4-dione |
| 1-[(5--(p-Nitro-phenyl)-fur-furyl-idene)-amino]-hydan-toin sodium salt |
| 1-[(5-[p-Nitrophenyl]-furfurylidene)amino]hydantoin |
| 1-[(E)-[5-(4-nitrophenyl)furan-2-yl]methylideneamino]imidazolidine-2,4-dione |
| 1-[[[5-(4-Io>>u+/-(1/2))-2-ss>>a<<>>u]NC(1/4)x>>u degrees +/->>u]-2,4-ssassosso paragraph signthornI feminine AAENI |
| 1-[[[5-(4-Nitrophenyl)-2-furanyl]methylene]amino]-2,4-imidazolidinedione Sodium Salt Hemiheptahydrate |
| 1-[[[5-(4-Nitrophenyl)-2-furanyl]methylene]amino]-2,4-imidazolinedione sodium salt |
| 1-[[5-(p-Nitrophenyl)furfurylidene]amino]hydantoin |
| 1-[5-(4-nitro-phenyl)-furan-2-ylmethyleneamino]-imidazolidine-2,4-dione |
| 1-[5-(4-Nitrophenyl)furfurylideneamino]hydantoin Sodium Salt |
| 14663-23-1 |
| 2,4-Imidazolidinedione, 1-(((5-(4-nitrophenyl)-2-furanyl)methylene)amino)- |
| 2,4-Imidazolidinedione, 1-(((5-(4-nitrophenyl)-2-furanyl)methylene)amino)-, sodium salt |
| 2,4-Imidazolidinedione, 1-(((5-(4-nitrophenyl)-2-furanyl)methylene)amino)-, sodium salt, hydrate (2:7) |
| 2,4-Imidazolidinedione, 1-[[[5-(4-nitrophenyl)-2-furanyl]methylene]amino]- |
| 2,4-Imidazolidinedione, 1-[[[5-(4-nitrophenyl)-2-furanyl]methylene]amino]-, sodium salt, hydrate |
| 24868-20-0 |
| 28F0G1E0VF |
| 2C14H9N4O5.2Na |
| 2C14H9N4O5.2Na.7H2O |
| 7261-97-4 |
| 85008-71-5 |
| AB0011237 |
| AC1O7G8U |
| AC1OC9NE |
| AKOS015895197 |
| AKOS015895198 |
| anhydrous dantrolene sodium |
| B6329 |
| BCBcMAP01_000067 |
| BDBM50198767 |
| BIDD:GT0187 |
| BPBio1_000246 |
| BRD-K81272440-001-02-6 |
| BRD-K81272440-236-05-1 |
| BRN 0705189 |
| BSPBio_000222 |
| BSPBio_001305 |
| BSPBio_003074 |
| C06939 |
| C07933 |
| C14H10N4O5 |
| C14H9N4O5.Na |
| CCG-220291 |
| CCG-40324 |
| CHEBI:4317 |
| CHEBI:4318 |
| CHEMBL1201288 |
| CHEMBL928 |
| CPD000326766 |
| CS-5234 |
| D02347 |
| D3996 |
| Dantamacrin |
| Dantrium |
| Dantrium Intravenous |
| Dantrix |
| dantrolene |
| Dantrolene (sodium) |
| Dantrolene (USAN/INN) |
| Dantrolene [USAN:BAN:INN] |
| Dantrolene [USAN:INN:BAN] |
| DANTROLENE SODIUM |
| Dantrolene Sodium (anhydrous) |
| Dantrolene sodium [USAN:BAN:JAN] |
| Dantrolene sodium anhydrous |
| Dantrolene sodium hemiheptahydrate |
| Dantrolene sodium salt |
| Dantrolene, Sodium Salt |
| Dantroleno |
| Dantroleno [INN-Spanish] |
| Dantrolenum |
| Dantrolenum [INN-Latin] |
| DB01219 |
| EINECS 230-684-8 |
| EINECS 238-706-8 |
| EU-0100424 |
| F 440 |
| F-368 |
| F-440 |
| F64QU97QCR |
| HMS1361B07 |
| HMS1568L04 |
| HMS1791B07 |
| HMS1989B07 |
| HMS2092N12 |
| HMS2095L04 |
| HMS3261E10 |
| HMS3266G14 |
| HMS3402B07 |
| HMS3712L04 |
| HMS502M20 |
| HSDB 3050 |
| HY-14657 |
| Hydantoin, 1-((5-(p-nitrophenyl)furfurylidene)amino)- |
| Hydantoin, 1-((5-(p-nitrophenyl)furfurylidene)amino)-, sodium salt |
| Hydantoin, 1-((5-(p-nitrophenyl)furfurylidene)amino)-, sodium salt, hydrate (2:7) |
| I06-0335 |
| I06-0336 |
| IDI1_000898 |
| IDI1_033775 |
| Lopac0_000424 |
| LS-174074 |
| LS-76264 |
| LS-76265 |
| MFCD00079130 |
| MLS000859905 |
| MLS002153441 |
| MolPort-003-666-797 |
| MolPort-006-069-178 |
| NCGC00093847-01 |
| NCGC00163132-01 |
| NCGC00163402-01 |
| NCGC00163402-02 |
| NCGC00163402-03 |
| NCGC00188950-01 |
| OZOMQRBLCMDCEG-VIZOYTHASA-N |
| potassium 1-({[5-(4-nitrophenyl)furan-2-yl]methylidene}amino)-4-oxo-5H-imidazol-2-olate |
| Prestwick2_000291 |
| Prestwick3_000291 |
| R452 |
| SAM002703135 |
| SCHEMBL12417164 |
| SCHEMBL40893 |
| SMR000326766 |
| sodium 1-[(E)-{[5-(4-nitrophenyl)furan-2-yl]methylidene}amino]-4-oxo-5H-imidazol-2-olate |
| sodium 3-({[5-(4-nitrophenyl)furan-2-yl]methylidene}amino)-2,5-dioxoimidazolidin-1-ide |
| sodium 3-[(E)-[5-(4-nitrophenyl)furan-2-yl]methylideneamino]-5-oxo-4H-imidazol-2-olate |
| Sodium dantrolene |
| Sodium, Dantrolene |
| Spectrum5_001752 |
| SR-01000076241-8 |
| UNII-28F0G1E0VF |
| UNII-F64QU97QCR |
| ZINC7997966 |
US Patents and Regulatory Information for RYANODEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579-001 | Jul 22, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579-001 | Jul 22, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579-001 | Jul 22, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579-001 | Jul 22, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579-001 | Jul 22, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579-001 | Jul 22, 2014 | RX | Yes | Yes | 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 |
International Patents for RYANODEX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 4880449 | Start Trial |
| Canada | 2516667 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2005013919 | Start Trial |
| European Patent Office | 1603513 | Start Trial |
| European Patent Office | 1435781 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03000057 | Start Trial |
| Japan | 2007525439 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
