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Last Updated: July 4, 2020

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RYANODEX Drug Profile


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Which patents cover Ryanodex, and when can generic versions of Ryanodex launch?

Ryanodex is a drug marketed by Eagle Pharms and is included in one NDA. There are five patents 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. Eight suppliers are listed for this compound. Additional details are available on the dantrolene sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Ryanodex

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

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Drug patent expirations by year for RYANODEX
Drug Prices for RYANODEX

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Recent Clinical Trials for RYANODEX

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

See all RYANODEX clinical trials

US Patents and Regulatory Information for RYANODEX

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   Start Trial
Eagle Pharms RYANODEX dantrolene sodium FOR SUSPENSION;INTRAVENOUS 205579-001 Jul 22, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Eagle Pharms RYANODEX dantrolene sodium FOR SUSPENSION;INTRAVENOUS 205579-001 Jul 22, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Eagle Pharms RYANODEX dantrolene sodium FOR SUSPENSION;INTRAVENOUS 205579-001 Jul 22, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Eagle Pharms RYANODEX dantrolene sodium FOR SUSPENSION;INTRAVENOUS 205579-001 Jul 22, 2014 RX Yes Yes   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

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Serving leading biopharmaceutical companies globally:

Baxter
Merck
Medtronic
McKesson
Mallinckrodt
Johnson and Johnson

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