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Serving leading biopharmaceutical companies globally:

UBS
Dow
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Citi
AstraZeneca
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Moodys
Chinese Patent Office
McKinsey
Mallinckrodt

Generated: December 12, 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 Actavis Labs Fl Inc, Amneal Pharms, Epic Pharma Llc, Impax Labs Inc, Lannett Holdings Inc, Sandoz, Sciegen Pharms Inc, and King 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-three suppliers are listed for this compound.

Pharmacology for metaxalone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
SandozMETAXALONEmetaxaloneTABLET;ORAL040445-001Mar 31, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Amneal PharmsMETAXALONEmetaxaloneTABLET;ORAL203399-001Jun 21, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
King PharmsSKELAXINmetaxaloneTABLET;ORAL013217-003Aug 30, 2002ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Epic Pharma LlcMETAXALONEmetaxaloneTABLET;ORAL022503-001Jun 1, 2015DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis Labs Fl IncMETAXALONEmetaxaloneTABLET;ORAL203695-001Jun 15, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Impax Labs IncMETAXALONEmetaxaloneTABLET;ORAL040486-001Feb 27, 2015RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
King PharmsSKELAXINmetaxaloneTABLET;ORAL013217-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Sciegen Pharms IncMETAXALONEmetaxaloneTABLET;ORAL207466-001Aug 31, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Lannett Holdings IncMETAXALONEmetaxaloneTABLET;ORAL204770-001Nov 22, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
King PharmsSKELAXINmetaxaloneTABLET;ORAL013217-003Aug 30, 2002ABRXYesYes► Subscribe► 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
6,407,128 Method for increasing the bioavailability of metaxalone► Subscribe
8,168,664Metaxalone products, method of manufacture, and method of use► Subscribe
7,378,434Metaxalone products, method of manufacture, and method of use► Subscribe
6,683,102 Methods of using metaxalone in the treatment of musculoskeletal conditions► 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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Serving leading biopharmaceutical companies globally:

Queensland Health
Fish and Richardson
Farmers Insurance
Argus Health
Deloitte
Cantor Fitzgerald
Covington
Moodys
Fuji
McKesson

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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