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Last Updated: June 14, 2021

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DANTRIUM Drug Profile


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Which patents cover Dantrium, and what generic alternatives are available?

Dantrium is a drug marketed by Par Sterile Products and is included in two NDAs.

The generic ingredient in DANTRIUM 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dantrium

A generic version of DANTRIUM was approved as dantrolene sodium by IMPAX LABS on March 1st, 2005.

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Drug patent expirations by year for DANTRIUM
Drug Prices for DANTRIUM

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Recent Clinical Trials for DANTRIUM

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

SponsorPhase
Beth Israel Deaconess Medical CenterPhase 2
American Heart AssociationPhase 1/Phase 2
University of Massachusetts, WorcesterPhase 1/Phase 2

See all DANTRIUM clinical trials

US Patents and Regulatory Information for DANTRIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-001 Approved Prior to Jan 1, 1982 AB RX Yes No   Get Started Free   Get Started Free   Get Started Free
Par Sterile Products DANTRIUM dantrolene sodium INJECTABLE;INJECTION 018264-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-003 Approved Prior to Jan 1, 1982 AB RX Yes No   Get Started Free   Get Started Free   Get Started Free
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-002 Approved Prior to Jan 1, 1982 AB RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>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 DANTRIUM

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

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Serving leading biopharmaceutical companies globally:

Colorcon
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Boehringer Ingelheim
Merck
Harvard Business School
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