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, Eugia Pharma Speclts, Hikma, 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. Eleven 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
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	2
Patent Applications:	1,172
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for dantrolene sodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1/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	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Par Sterile Products	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
>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	See Plans and Pricing	See Plans and Pricing
Par Sterile Products	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982	See Plans and Pricing	See Plans and Pricing
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for dantrolene sodium

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	03000057		See Plans and Pricing
Canada	2516667	TRAITEMENT AU MOYEN DE DANTROLENE (TREATMENT USING DANTROLENE)	See Plans and Pricing
World Intellectual Property Organization (WIPO)	2005013919		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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