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Dantrolene sodium - Generic Drug Details

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:	2
Patent Applications:	3,404
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for dantrolene sodium
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

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Glossary

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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	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Hikma Pharms	DANTROLENE SODIUM	dantrolene sodium	INJECTABLE;INJECTION	204762-001	Jun 19, 2017	AP	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Par Sterile Products	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
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 dantrolene sodium

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

International Patents for dantrolene sodium

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Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	03000057	➤ Sign Up
Canada	2516667	➤ Sign Up
Japan	4880449	➤ Sign Up
European Patent Office	1603513	➤ Sign Up
Country	Document Number	Estimated Expiration