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Last Updated: March 19, 2024

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 Par Sterile Products, 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.

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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 1/Phase 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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Impax Labs DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076856-003 Mar 1, 2005 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Impax Labs DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076856-002 Mar 1, 2005 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Sterile Products DANTRIUM dantrolene sodium INJECTABLE;INJECTION 018264-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-003 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma Speclts DANTROLENE SODIUM dantrolene sodium INJECTABLE;INJECTION 205239-001 Feb 18, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 INJECTABLE;INJECTION 018264-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Eagle Pharms RYANODEX dantrolene sodium FOR SUSPENSION;INTRAVENOUS 205579-001 Jul 22, 2014 ⤷  Try a Trial ⤷  Try a Trial
Eagle Pharms RYANODEX dantrolene sodium FOR SUSPENSION;INTRAVENOUS 205579-001 Jul 22, 2014 ⤷  Try a Trial ⤷  Try a Trial
Eagle Pharms RYANODEX dantrolene sodium FOR SUSPENSION;INTRAVENOUS 205579-001 Jul 22, 2014 ⤷  Try a Trial ⤷  Try a Trial
Eagle Pharms RYANODEX dantrolene sodium FOR SUSPENSION;INTRAVENOUS 205579-001 Jul 22, 2014 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for DANTROLENE SODIUM

Country Patent Number Title Estimated Expiration
Japan 2007525439 ⤷  Try a Trial
Japan 4880449 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 03000057 ⤷  Try a Trial
Australia 2004262507 ⤷  Try a Trial
European Patent Office 1435781 ⤷  Try a Trial
European Patent Office 1603513 COMPOSITIONS DE DANTROLÈNE (DANTROLENE COMPOSITIONS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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