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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.

Summary for RYANODEX

International Patents:	8
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	52
Clinical Trials:	3
Patent Applications:	2,338
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RYANODEX
DailyMed Link:	RYANODEX at DailyMed

See drug prices for RYANODEX

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

See all RYANODEX clinical trials

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
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014		RX	Yes	Yes			Y
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014		RX	Yes	Yes			Y

International Patents for RYANODEX

Country	Patent Number	Estimated Expiration
Australia	2004262507
European Patent Office	1435781
Japan	2007525439