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Last Updated: July 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 Endo Operations, 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
Elite Labs Inc DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076686-001 Oct 24, 2005 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Elite Labs Inc DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076686-003 Oct 24, 2005 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax Labs DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076856-001 Mar 1, 2005 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Operations DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-001 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  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 DANTROLENE SODIUM

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
Endo Operations DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-001 Approved Prior to Jan 1, 1982 ⤷  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

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