Dantrolene sodium - Generic Drug Details

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What are the generic drug sources for dantrolene sodium and what is the scope of freedom to operate?

Dantrolene sodium is the generic ingredient in four branded drugs marketed by Par Sterile Products, Elite Labs Inc, Impax Labs, Eagle Pharms, Hikma, Mylan Institutional, and Uswm, 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:	120
Clinical Trials:	2
Patent Applications:	3,739
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for dantrolene sodium
What excipients (inactive ingredients) are in dantrolene sodium?	dantrolene sodium excipients list
DailyMed Link:	dantrolene sodium at DailyMed

See drug prices for dantrolene sodium

Recent Clinical Trials for dantrolene sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Beth Israel Deaconess Medical Center	Phase 2
Washington University School of Medicine	Phase 1/Phase 2

See all dantrolene sodium clinical trials

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

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	Start Trial	Start Trial	Y			Start Trial
Elite Labs Inc	DANTROLENE SODIUM	dantrolene sodium	CAPSULE;ORAL	076686-003	Oct 24, 2005	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Elite Labs Inc	DANTROLENE SODIUM	dantrolene sodium	CAPSULE;ORAL	076686-002	Oct 24, 2005	AB	RX	No	No	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

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

International Patents for dantrolene sodium

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Country	Patent Number	Estimated Expiration
Japan	4880449	Start Trial
European Patent Office	1435781	Start Trial
European Patent Office	1603513	Start Trial
>Country	>Patent Number	>Estimated Expiration

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