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Last Updated: May 8, 2021

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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 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, Hikma, Mylan Institutional, and Uswm, 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. Ten 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
Elite Labs Inc DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076686-003 Oct 24, 2005 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Par Sterile Products DANTRIUM dantrolene sodium INJECTABLE;INJECTION 018264-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Impax Labs DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076856-003 Mar 1, 2005 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
>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 017443-002 Approved Prior to Jan 1, 1982   Get Started for $10   Get Started for $10
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-001 Approved Prior to Jan 1, 1982   Get Started for $10   Get Started for $10
Par Sterile Products DANTRIUM dantrolene sodium INJECTABLE;INJECTION 018264-001 Approved Prior to Jan 1, 1982   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Baxter
Colorcon
Johnson and Johnson
Harvard Business School
Boehringer Ingelheim

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