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Last Updated: August 8, 2020

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Dantrolene sodium - Generic Drug Details

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What are the generic drug sources for dantrolene sodium and what is the scope of patent protection?

Dantrolene sodium is the generic ingredient in four branded drugs marketed by Par Sterile Products, Elite Labs Inc, Impax Labs, Eagle Pharms, Hikma Pharms, Mylan Institutional, and Us Worldmeds, 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. Eight suppliers are listed for this compound.

Drug Prices for dantrolene sodium

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Recent Clinical Trials for dantrolene sodium

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

SponsorPhase
Beth Israel Deaconess Medical CenterPhase 2
Washington University School of MedicinePhase 1/Phase 2

See all dantrolene sodium clinical trials

Pharmacology for dantrolene sodium
Medical Subject Heading (MeSH) Categories for dantrolene sodium

US Patents and Regulatory Information for dantrolene sodium

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 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
Eagle Pharms RYANODEX dantrolene sodium FOR SUSPENSION;INTRAVENOUS 205579-001 Jul 22, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Elite Labs Inc DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076686-003 Oct 24, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-001 Approved Prior to Jan 1, 1982 AB RX Yes No   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
Elite Labs Inc DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076686-001 Oct 24, 2005 AB RX No No   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

Expired US Patents for dantrolene sodium

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   Start Trial   Start Trial
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Par Sterile Products DANTRIUM dantrolene sodium INJECTABLE;INJECTION 018264-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for dantrolene sodium

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
McKesson
Dow
Harvard Business School
Medtronic

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