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 Endo Operations, Elite Labs Inc, Impax Labs, Eagle Pharms, Eugia Pharma Speclts, Hikma, and Uswm, and is included in eight NDAs. There is one patent 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. Twelve suppliers are listed for this compound.

Summary for DANTROLENE SODIUM

International Patents:	8
US Patents:	1
Tradenames:	4
Applicants:	7
NDAs:	8
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	2
Patent Applications:	11
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

Anatomical Therapeutic Chemical (ATC) Classes for DANTROLENE SODIUM

M03CA	Dantrolene and derivatives
M03C	MUSCLE RELAXANTS, DIRECTLY ACTING AGENTS
M03	MUSCLE RELAXANTS
M	Musculo-skeletal system

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
Endo Operations	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Elite Labs Inc	DANTROLENE SODIUM	dantrolene sodium	CAPSULE;ORAL	076686-001	Oct 24, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	DANTROLENE SODIUM	dantrolene sodium	INJECTABLE;INJECTION	204762-001	Jun 19, 2017	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs	DANTROLENE SODIUM	dantrolene sodium	CAPSULE;ORAL	076856-003	Mar 1, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014	⤷ Sign Up	⤷ Sign Up
Eagle Pharms	RYANODEX	dantrolene sodium	FOR SUSPENSION;INTRAVENOUS	205579-001	Jul 22, 2014	⤷ Sign Up	⤷ Sign Up
Endo Operations	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	Patent Number	Title	Estimated Expiration
Japan	4880449		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2005013919		⤷ Sign Up
World Intellectual Property Organization (WIPO)	03000057		⤷ Sign Up
Japan	2007525439		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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