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Dantrolene sodium - Generic Drug Details

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What are the generic sources for dantrolene sodium and what is the scope of dantrolene sodium patent protection?

Dantrolene sodium is the generic ingredient in four branded drugs marketed by Par Sterile Products, Elite Labs Inc, Impax Labs, Eagle Pharms, Hikma Pharms, Mylan Institutional, and Us Worldmeds, and is included in eight NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dantrolene sodium has eight patent family members in five countries.

There are five drug master file entries for dantrolene sodium. Eight suppliers are listed for this compound.

Summary for dantrolene sodium

International Patents:	8
US Patents:	5
Tradenames:	4
Applicants:	7
NDAs:	8
Drug Master File Entries:	5
Suppliers / Packagers:	8
Bulk Api Vendors:	79
Clinical Trials:	1
Patent Applications:	3,369
Formulation / Manufacturing:	see details
DailyMed Link:	dantrolene sodium at DailyMed

Pharmacology for dantrolene sodium

Drug Class	Skeletal Muscle Relaxant
Physiological Effect	Decreased Striated Muscle Contraction Decreased Striated Muscle Tone

Medical Subject Heading (MeSH) Categories for dantrolene sodium

Muscle Relaxants, Central

Synonyms for dantrolene sodium

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 anion

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

1-{(5-{p-nitrophenyl}furfurylidene)-amino}hydantoin sodium

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

287M0347EV

28F0G1E0VF

2C14H9N4O5.2Na

2C14H9N4O5.2Na.7H2O

3-({[5-(4-nitrophenyl)furan-2-yl]methylidene}amino)-2,5-dioxoimidazolidin-1-ide

3-[(E)-[5-(4-nitrophenyl)furan-2-yl]methylideneamino]-5-oxo-4H-imidazol-2-olate

63D231

663D231

7261-97-4

A817527

AB00053743_02

AB0011237

AB00513823

AC-25752

AC1O7G8U

AC1O7GSO

AC1OC9NE

AKOS015895197

AKOS015895198

AKOS015902289

AKOS015963269

Ambap14663-23-1

anhydrous dantrolene sodium

B6329

BC215665

BCBcMAP01_000067

BDBM200293

BIDD:GT0187

BPBio1_000246

BRD-K81272440-001-02-6

BRD-K81272440-236-05-1

BRN 0705189

BSPBio_000222

BSPBio_001305

BSPBio_003074

C-22163

C06939

C07933

C14H10N4O5

C14H9N4O5.Na

CCG-204516

CCG-220291

CCG-221728

CCG-40324

CHEBI:184644

CHEBI:4317

CHEBI:4318

CHEBI:59697

CHEMBL1201288

CHEMBL928

cid_6604728

CPD000326766

CS-5234

D 9175

D02274

D02347

D0I8DD

D3996

Dantamacrin

Dantrium

Dantrium (TN)

Dantrium Intravenous

Dantrix

Dantrolen (TN)

dantrolene

Dantrolene (sodium salt)

Dantrolene (sodium)

Dantrolene (USAN/INN)

Dantrolene [USAN:BAN:INN]

Dantrolene [USAN:INN:BAN]

dantrolene anion

Dantrolene Sodium (anhydrous)

Dantrolene sodium (USAN)

Dantrolene sodium [USAN:BAN:JAN]

Dantrolene sodium [USAN:USP:BAN:JAN]

Dantrolene sodium anhydrous

Dantrolene sodium hemiheptahydrate

Dantrolene Sodium Hydrate

Dantrolene sodium hydrate (JP17)

Dantrolene sodium salt

Dantrolene, Sodium Salt

dantrolene(1-)

Dantrolenesodium

Dantroleno

Dantroleno [INN-Spanish]

Dantrolenum

Dantrolenum [INN-Latin]

DB01219

disodium 3-[(E)-[5-(4-nitrophenyl)-2-furanyl]methylideneamino]-5-oxo-4H-imidazol-2-olate heptahydrate

disodium 3-[(E)-[5-(4-nitrophenyl)furan-2-yl]methylideneamino]-5-oxidanylidene-4H-imidazol-2-olate heptahydrate

disodium;1-[(E)-[5-(4-nitrophenyl)furan-2-yl]methylideneamino]imidazolidin-3-ide-2,4-dione;heptahydrate

EINECS 230-684-8

EINECS 238-706-8

EU-0100424

F 440

F-368

F-440

F64QU97QCR

FT-0082847

HMS1361B07

HMS1568L04

HMS1791B07

HMS1989B07

HMS2092N12

HMS2095L04

HMS3261E10

HMS3266G14

HMS3402B07

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

I14-13402

IDI1_000898

IDI1_033775

J-015708

Lopac0_000424

LS-174074

LS-76264

LS-76265

MFCD00079130

MLS000859905

MLS002153441

MolPort-003-666-797

MolPort-006-069-178

NCGC00024622-02

NCGC00024622-03

NCGC00024622-04

NCGC00093847-01

NCGC00163132-01

NCGC00163402-01

NCGC00163402-02

NCGC00163402-03

NCGC00188950-01

NCGC00261109-01

NSC-758403

NSC758403

OZOMQRBLCMDCEG-VIZOYTHASA-N

Pharmakon1600-01503209

potassium 1-({[5-(4-nitrophenyl)furan-2-yl]methylidene}amino)-4-oxo-5H-imidazol-2-olate

Prestwick2_000291

Prestwick3_000291

R452

Ryanodex

SAM002703135

SBI-0050409.P003

SCHEMBL12417164

SCHEMBL2903719

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-({[5-(4-nitrophenyl)furan-2-yl]methylidene}amino)-2,5-dioxoimidazolidin-1-ide--water (2/7)

sodium 3-[(E)-[5-(4-nitrophenyl)furan-2-yl]methylideneamino]-5-oxo-4H-imidazol-2-olate

Sodium dantrolene

Sodium, Dantrolene

Spectrum5_001752

SR-01000076241

SR-01000076241-1

ST51052737

Tox21_500424

TR-005822

UNII-287M0347EV

UNII-28F0G1E0VF

UNII-F64QU97QCR

ZINC7997966

US Patents and Regulatory Information for dantrolene sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Sterile Products	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Mylan Institutional	DANTROLENE SODIUM	dantrolene sodium	INJECTABLE;INJECTION	205239-001	Feb 18, 2016	AP	RX	No	No
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014		RX	Yes	Yes			Y
Impax Labs	DANTROLENE SODIUM	dantrolene sodium	CAPSULE;ORAL	076856-002	Mar 1, 2005	AB	RX	No	No

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Expired US Patents for dantrolene sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Par Sterile Products	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-001	Approved Prior to Jan 1, 1982
Par Sterile Products	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-002	Approved Prior to Jan 1, 1982
Par Sterile Products	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982
Par Sterile Products	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-003	Approved Prior to Jan 1, 1982

Non-Orange Book US Patents for dantrolene sodium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,271,964	Treatment using dantrolene
9,603,840	Treatment using dantrolene
9,789,090	Treatment using dantrolene

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International Patents for dantrolene sodium

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005013919
Australia	2004262507
Japan	2007525439
European Patent Office	1603513