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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Julphar
Deloitte
Boehringer Ingelheim
Fish and Richardson
Chinese Patent Office
Citi
US Department of Justice
Cipla
Cantor Fitzgerald

Generated: January 23, 2018

DrugPatentWatch Database Preview

Dantrolene sodium - Generic Drug Details

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What are the generic sources for dantrolene sodium and what is the scope of dantrolene sodium 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 four 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. Nine suppliers are listed for this compound.
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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-003 Approved Prior to Jan 1, 1982 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Elite Labs Inc DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076686-003 Oct 24, 2005 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Impax Labs DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076856-001 Mar 1, 2005 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Eagle Pharms RYANODEX dantrolene sodium FOR SUSPENSION;INTRAVENOUS 205579-001 Jul 22, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Us Worldmeds REVONTO dantrolene sodium INJECTABLE;INJECTION 078378-001 Jul 24, 2007 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Institutional DANTROLENE SODIUM dantrolene sodium INJECTABLE;INJECTION 205239-001 Feb 18, 2016 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Elite Labs Inc DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076686-002 Oct 24, 2005 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Sterile Products DANTRIUM dantrolene sodium INJECTABLE;INJECTION 018264-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Impax Labs DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076856-003 Mar 1, 2005 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Non-Orange Book US Patents for dantrolene sodium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,271,964 Treatment using dantrolene ➤ Subscribe
9,603,840 Treatment using dantrolene ➤ Subscribe
9,789,090 Treatment using dantrolene ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for dantrolene sodium

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Federal Trade Commission
US Army
Cantor Fitzgerald
Deloitte
Colorcon
McKesson
UBS
Julphar

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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