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Last Updated: May 24, 2022

RYANODEX Drug Patent 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. Ten suppliers are listed for this compound. Additional details are available on the dantrolene sodium profile page.

Drug patent expirations by year for RYANODEX
Drug Prices for RYANODEX

See drug prices for RYANODEX

Recent Clinical Trials for RYANODEX

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

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

See all RYANODEX clinical trials

US Patents and Regulatory Information for RYANODEX

RYANODEX is protected by five US patents.

Patents protecting RYANODEX

Treatment using dantrolene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Treatment using dantrolene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Treatment using dantrolene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Treatment using dantrolene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR USE IN THE TREATMENT OF MALIGNANT HYPERTHERMIA IN CONJUNCTION WITH APPROPRIATE SUPPORTIVE MEASURES AND FOR THE PREVENTION OF MALIGNANT HYPERTHERMIA IN PATIENTS AT HIGH RISK.

Treatment using dantrolene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR USE IN THE TREATMENT OF MALIGNANT HYPERTHERMIA IN CONJUNCTION WITH APPROPRIATE SUPPORTIVE MEASURES AND FOR THE PREVENTION OF MALIGNANT HYPERTHERMIA IN PATIENTS AT HIGH RISK.

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 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
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
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

International Patents for RYANODEX

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

Country Patent Number Title Estimated Expiration
Japan 4880449 See Plans and Pricing
European Patent Office 1603513 COMPOSITIONS DE DANTROL├łNE (DANTROLENE COMPOSITIONS) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2005013919 See Plans and Pricing
Japan 2007525439 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Merck
Medtronic
McKesson
Mallinckrodt
Johnson and Johnson

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