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Dantrolene sodium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for dantrolene sodium?

Dantrolene sodium is the generic ingredient in four branded drugs marketed by Mylan Institutional, Par Sterile Products, Impax Labs, Us Worldmeds, Eagle Pharms, and Elite Labs Inc, and is included in seven 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. Nine suppliers are listed for this compound.

Summary for Generic Name: dantrolene sodium

Tradenames:4
Patents:5
Applicants:6
NDAs:7
Drug Master File Entries: see list5
Suppliers / Packagers: see list9
Bulk Api Vendors: see list62
Clinical Trials: see list920
Patent Applications: see list3,077
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:dantrolene sodium at DailyMed

Pharmacology for Ingredient: dantrolene sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eagle Pharms
RYANODEX
dantrolene sodium
FOR SUSPENSION;INTRAVENOUS205579-001Jul 22, 2014RXYesYes► Subscribe► Subscribe
Eagle Pharms
RYANODEX
dantrolene sodium
FOR SUSPENSION;INTRAVENOUS205579-001Jul 22, 2014RXYesYes7,758,890► SubscribeY ► Subscribe
Us Worldmeds
REVONTO
dantrolene sodium
INJECTABLE;INJECTION078378-001Jul 24, 2007RXNoNo► Subscribe► Subscribe
Mylan Institutional
DANTROLENE SODIUM
dantrolene sodium
INJECTABLE;INJECTION205239-001Feb 18, 2016RXNoNo► Subscribe► Subscribe
Elite Labs Inc
DANTROLENE SODIUM
dantrolene sodium
CAPSULE;ORAL076686-001Oct 24, 2005RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: dantrolene sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Par Sterile Products
DANTRIUM
dantrolene sodium
CAPSULE;ORAL017443-001Approved Prior to Jan 1, 19823,415,821► Subscribe
Par Sterile Products
DANTRIUM
dantrolene sodium
CAPSULE;ORAL017443-003Approved Prior to Jan 1, 19823,415,821► Subscribe
Par Sterile Products
DANTRIUM
dantrolene sodium
INJECTABLE;INJECTION018264-001Approved Prior to Jan 1, 19823,415,821► Subscribe
Par Sterile Products
DANTRIUM
dantrolene sodium
CAPSULE;ORAL017443-002Approved Prior to Jan 1, 19823,415,821► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,271,964Treatment using dantrolene► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: dantrolene sodium

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)03000057► Subscribe
Japan2007525439► Subscribe
Australia2004262507► Subscribe
Japan4880449► Subscribe
European Patent Office1435781► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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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