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RADICAVA Drug Profile
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See Plans and PricingWhen do Radicava patents expire, and when can generic versions of Radicava launch?
Radicava is a drug marketed by Mitsubishi Tanabe and is included in one NDA. There is one patent protecting this drug.
This drug has seven patent family members in six countries.
The generic ingredient in RADICAVA is edaravone. Additional details are available on the edaravone profile page.
US ANDA Litigation and Generic Entry Outlook for Radicava
Radicava will be eligible for patent challenges on May 5, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 5, 2024. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for RADICAVA
| International Patents: | 7 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 130 |
| Clinical Trials: | 3 |
| Patent Applications: | 999 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RADICAVA |
| DailyMed Link: | RADICAVA at DailyMed |
Generic Entry Opportunity Date for RADICAVA
Generic Entry Date for RADICAVA*:
Constraining patent/regulatory exclusivity:
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) NDA:
Dosage:
SOLUTION;INTRAVENOUS |
*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 RADICAVA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mitsubishi Tanabe Pharma Corporation | Phase 1 |
| University of Calgary | Phase 2 |
| ALS Canada | Phase 2 |
Synonyms for RADICAVA
| (MCI-186) |
| 1-Fenyl-3-methyl-2-pyrazolin-5-on |
| 1-Fenyl-3-methyl-2-pyrazolin-5-on [Czech] |
| 1-PEHNYL-3-METHYL-5-PYRAZALONE |
| 1-Phenyl-3-methyl-2-pyrazolin-5-on |
| 1-Phenyl-3-methyl-5-oxo-2-pyrazoline |
| 1-Phenyl-3-methyl-5-pyrazolone |
| 1-Phenyl-3-methylpyrazolone |
| 1-Phenyl-3-methylpyrazolone-5 |
| 115566-83-1 |
| 12235-58-4 |
| 2 4-Dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one |
| 2-Pyrazolin-5-one, 3-methyl-1-phenyl- |
| 2,4-dihydro-2-phenyl-5-methyl-3H-pyrazol-3-one |
| 2,4-Dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one |
| 206195-95-1 |
| 3-Methyl-1-phenyl-1H-pyrazol-5(4H)-one |
| 3-METHYL-1-PHENYL-2-PYRAZOLIN-5-ONE |
| 3-METHYL-1-PHENYL-2-PYRAZOLIN-5-ONE (MCI-186) |
| 3-Methyl-1-phenyl-2-pyrazolin-5-one, 99% |
| 3-methyl-1-phenyl-2-pyrazolin-5one |
| 3-Methyl-1-phenyl-2-pyrazoline-5-one |
| 3-Methyl-1-phenyl-2-pyrazoline-5-one, 99% |
| 3-Methyl-1-phenyl-2-pyrazoline-5-one, purum, >=98.0% (NT) |
| 3-Methyl-1-phenyl-2-pyrazoline-5-one, SAJ special grade |
| 3-methyl-1-phenyl-4,5-dihydro-1H-pyrazol-5-one |
| 3-Methyl-1-phenylpyrazol-5-one |
| 3H-Pyrazol-3-one, 2,4-dihydro-5-methyl-2-phenyl- |
| 3H-Pyrazol-3-one,4-dihydro-5-methyl-2-phenyl- |
| 4CA-0486 |
| 4E-901 |
| 5-methyl-2-phenyl-2,4-dihydro-3-pyrazolone |
| 5-Methyl-2-phenyl-2,4-dihydro-3H-pyrazol-3-one |
| 5-Methyl-2-phenyl-2,4-dihydro-3H-pyrazol-3-one (Edaravone) |
| 5-Methyl-2-phenyl-2,4-dihydro-3H-pyrazol-3-one # |
| 5-methyl-2-phenyl-2,4-dihydro-pyrazol-3-one |
| 5-methyl-2-phenyl-2,4-dihydropyrazol-3-one |
| 5-methyl-2-phenyl-4H-pyrazol-3-one |
| 5-Pyrazolone, 3-methyl-1-phenyl- |
| 52224-17-6 |
| 62495-97-0 |
| 72134-66-8 |
| 89-25-8 |
| AB00375776_14 |
| AB00375776_15 |
| AB2000046 |
| AC-4745 |
| AC1L1H8H |
| AC1Q2PHG |
| AC1Q6EYP |
| ACT07289 |
| AE-641/00371017 |
| AI3-03557 |
| AJ-70469 |
| AK128848 |
| AKOS000313817 |
| AM20060748 |
| AN-11638 |
| Antipyrine Related Compound A, United States Pharmacopeia (USP) Reference Standard |
| BBL011741 |
| BC205186 |
| BCBcMAP01_000127 |
| BCP26336 |
| BCP9000635 |
| BCPP000246 |
| BDBM50200541 |
| Bio1_000438 |
| Bio1_000927 |
| Bio1_001416 |
| Bio2_000448 |
| Bio2_000928 |
| BRD-K35458079-001-04-2 |
| BRD-K35458079-001-12-5 |
| BRD-K35458079-001-23-2 |
| BRN 0609575 |
| BSPBio_001235 |
| BSPBio_002601 |
| C.I. Developer 1 |
| C13008 |
| CAS-89-25-8 |
| CCG-39352 |
| CCRIS 512 |
| CDS1_000986 |
| CHEBI:31530 |
| CHEMBL290916 |
| CI Developer 1 |
| CS-1832 |
| CTK3E8611 |
| D01552 |
| DB-002517 |
| DB12243 |
| Developer Z |
| DivK1c_001018 |
| DivK1c_002026 |
| DSSTox_CID_1130 |
| DSSTox_GSID_21130 |
| DSSTox_RID_75961 |
| DTXSID9021130 |
| EC 201-891-0 |
| edaravone |
| Edaravone (JP17/INN) |
| Edaravone (MCI-186) |
| Edaravone [USAN:INN] |
| edaravone(jan) |
| EINECS 201-891-0 |
| F0391-0021 |
| FT-0608243 |
| HMS1362M17 |
| HMS1792M17 |
| HMS1990M17 |
| HMS2234M19 |
| HMS3266F04 |
| HMS3403M17 |
| HMS3654L15 |
| HMS503K17 |
| HMS557M18 |
| HSDB 4102 |
| HY-B0099 |
| I01-2810 |
| IDI1_001018 |
| IDI1_002203 |
| IN1263 |
| InChI=1/C10H10N2O/c1-8-7-10(13)12(11-8)9-5-3-2-4-6-9/h2-6H,7H2,1H |
| KB-183502 |
| KBio1_001018 |
| KBio2_000575 |
| KBio2_000747 |
| KBio2_003143 |
| KBio2_003315 |
| KBio2_005711 |
| KBio2_005883 |
| KBio3_001029 |
| KBio3_001030 |
| KBio3_001821 |
| KBioGR_000575 |
| KBioGR_001502 |
| KBioSS_000575 |
| KBioSS_000747 |
| KS-00000X6I |
| KSC448M1D |
| LS-1892 |
| M0687 |
| Maybridge1_005738 |
| MCI-186 |
| MCI-186, Radicut, 89-25-8 |
| Methylphenylpyrazolone |
| MFCD00003138 |
| MLS000069602 |
| MLS001146878 |
| MLS002415675 |
| MLS006011753 |
| MolPort-000-182-197 |
| Monopyrazolone |
| NCGC00018218-01 |
| NCGC00018218-02 |
| NCGC00018218-03 |
| NCGC00018218-04 |
| NCGC00018218-05 |
| NCGC00018218-06 |
| NCGC00018218-07 |
| NCGC00018218-08 |
| NCGC00018218-10 |
| NCGC00018218-17 |
| NCGC00022665-02 |
| NCGC00022665-04 |
| NCGC00022665-05 |
| NCGC00022665-06 |
| NCGC00164015-01 |
| NCGC00256515-01 |
| NCGC00259296-01 |
| NCI-C03952 |
| NE10266 |
| NINDS_001018 |
| Norantipyrine |
| Norphenazone |
| NSC 12 |
| NSC-26139 |
| NSC-2629 |
| NSC-758622 |
| NSC26139 |
| NSC2629 |
| NSC758622 |
| Opera_ID_1057 |
| Pharmakon1600-01503635 |
| Phenazone impurity A, European Pharmacopoeia (EP) Reference Standard |
| Phenyl methyl pyrazolone |
| Phenylmethylpyrazolone |
| PubChem13301 |
| Q-200386 |
| QELUYTUMUWHWMC-UHFFFAOYSA-N |
| Radicava (TN) |
| Radicut |
| Radicut (TN) |
| Radicut;MCI-186 |
| RL05601 |
| RTR-028045 |
| s1326 |
| SB19128 |
| SBI-0051836.P002 |
| SC-13582 |
| SCHEMBL4704 |
| SMR000059020 |
| SPBio_001508 |
| Spectrum_000267 |
| SPECTRUM1503635 |
| Spectrum2_001574 |
| Spectrum3_000971 |
| Spectrum4_001091 |
| Spectrum5_001217 |
| SR-01000000135 |
| SR-01000000135-2 |
| SR-01000000135-3 |
| SR-01000000135-5 |
| ST012744 |
| ST2410773 |
| STK201315 |
| SW148216-2 |
| Tocris-0786 |
| Tox21_112077 |
| Tox21_112077_1 |
| Tox21_201747 |
| Tox21_302819 |
| TR-028045 |
| WLN: T5NMV DHJ BR& E1 |
| Z50145861 |
| ZINC18203737 |
US Patents and Regulatory Information for RADICAVA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-001 | May 5, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-002 | Nov 15, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-001 | May 5, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-001 | May 5, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-002 | Nov 15, 2018 | RX | Yes | Yes | 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 |
International Patents for RADICAVA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 60022560 | Start Trial |
| European Patent Office | 1405637 | Start Trial |
| Japan | WO2002034264 | Start Trial |
| Japan | 3758164 | Start Trial |
| Austria | 303808 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
