RYANODEX Drug Patent Profile

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Which patents cover Ryanodex, and what generic alternatives are available?

Ryanodex is a drug marketed by Eagle Pharms and is included in one NDA. There is one patent protecting this drug.

This drug has eight patent family members in five countries.

The generic ingredient in RYANODEX is dantrolene sodium. There are five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dantrolene sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ryanodex

A generic version of RYANODEX was approved as dantrolene sodium by IMPAX LABS on March 1^st, 2005.

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Summary for RYANODEX

International Patents:	8
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	3
Patent Applications:	2,760
Drug Prices:	Drug price information for RYANODEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RYANODEX
What excipients (inactive ingredients) are in RYANODEX?	RYANODEX excipients list
DailyMed Link:	RYANODEX at DailyMed

Drug patent expirations by year for RYANODEX

Recent Clinical Trials for RYANODEX

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

Sponsor	Phase
Eagle Pharmaceuticals, Inc.	Phase 3
Quintiles, Inc.	Phase 2
Eagle Pharmaceuticals, Inc.	Phase 2

See all RYANODEX clinical trials

Pharmacology for RYANODEX

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

US Patents and Regulatory Information for RYANODEX

RYANODEX is protected by one US patents.

Patents protecting RYANODEX

Treatment using dantrolene
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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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
>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 RYANODEX

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for RYANODEX

See the table below for patents covering RYANODEX around the world.

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Country	Patent Number	Title	Estimated Expiration
Canada	2516667	TRAITEMENT AU MOYEN DE DANTROLENE (TREATMENT USING DANTROLENE)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	03000057		⤷ Sign Up
Japan	2007525439		⤷ Sign Up
European Patent Office	1603513	COMPOSITIONS DE DANTROLÈNE (DANTROLENE COMPOSITIONS)	⤷ Sign Up
Australia	2004262507		⤷ Sign Up
Japan	4880449		⤷ Sign Up
European Patent Office	1435781		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration