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Serving leading biopharmaceutical companies globally:

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McKinsey
Chinese Patent Office
US Department of Justice
Cantor Fitzgerald
Boehringer Ingelheim
Covington
Medtronic
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Federal Trade Commission

Generated: October 17, 2017

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Metaxalone - Generic Drug Details

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What are the generic sources for metaxalone and what is the scope of metaxalone patent protection?

Metaxalone
is the generic ingredient in two branded drugs marketed by Epic Pharma Llc, King Pharms, Sandoz, Sciegen Pharms Inc, Lannett Holdings Inc, Impax Labs Inc, Actavis Labs Fl Inc, and Amneal Pharms, and is included in eight NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Metaxalone has two patent family members in two countries.

There are nineteen drug master file entries for metaxalone. Forty-two suppliers are listed for this compound.

Summary for Generic Name: metaxalone

US Patents:2
Tradenames:2
Applicants:8
NDAs:8
Drug Master File Entries: see list19
Suppliers / Packagers: see list42
Bulk Api Vendors: see list64
Clinical Trials: see list1
Patent Applications: see list1,670
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:metaxalone at DailyMed

Pharmacology for Ingredient: metaxalone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
King Pharms
SKELAXIN
metaxalone
TABLET;ORAL013217-003Aug 30, 2002ABRXYesYes► Subscribe► Subscribe ► Subscribe
King Pharms
SKELAXIN
metaxalone
TABLET;ORAL013217-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Lannett Holdings Inc
METAXALONE
metaxalone
TABLET;ORAL204770-001Nov 22, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Sciegen Pharms Inc
METAXALONE
metaxalone
TABLET;ORAL207466-001Aug 31, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
METAXALONE
metaxalone
TABLET;ORAL040486-001Feb 27, 2015RXNoNo► Subscribe► Subscribe► Subscribe
Epic Pharma Llc
METAXALONE
metaxalone
TABLET;ORAL022503-001Jun 1, 2015DISCNNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms
METAXALONE
metaxalone
TABLET;ORAL203399-001Jun 21, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
METAXALONE
metaxalone
TABLET;ORAL040445-001Mar 31, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Labs Fl Inc
METAXALONE
metaxalone
TABLET;ORAL203695-001Jun 15, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
King Pharms
SKELAXIN
metaxalone
TABLET;ORAL013217-003Aug 30, 2002ABRXYesYes► Subscribe► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: metaxalone

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
7,378,434Metaxalone products, method of manufacture, and method of use► Subscribe
6,407,128 Method for increasing the bioavailability of metaxalone► Subscribe
6,683,102 Methods of using metaxalone in the treatment of musculoskeletal conditions► Subscribe
8,168,664Metaxalone products, method of manufacture, and method of use► 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: metaxalone

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2007094825► Subscribe
Canada2626027► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Healthtrust
Covington
Merck
Fuji
Federal Trade Commission
McKinsey
Citi
Chinese Patent Office
Daiichi Sankyo

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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