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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Cerilliant
US Army
Fish and Richardson
Accenture
Boehringer Ingelheim
Citi
Healthtrust
AstraZeneca

Generated: July 18, 2018

DrugPatentWatch Database Preview

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, Lannett Co Inc, Mountain, Primus Pharms, 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 twenty drug master file entries for metaxalone. Forty suppliers are listed for this compound.
Pharmacology for metaxalone

US Patents and Regulatory Information for 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;ORAL 013217-003 Aug 30, 2002 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Lannett Co Inc METAXALONE metaxalone TABLET;ORAL 204770-001 Nov 22, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Amneal Pharms METAXALONE metaxalone TABLET;ORAL 203399-001 Jun 21, 2013 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mountain METAXALONE metaxalone TABLET;ORAL 040486-001 Feb 27, 2015 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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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Non-Orange Book US Patents for 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
7,378,434 Metaxalone products, method of manufacture, and method of use ➤ Try a Free Trial
8,168,664 Metaxalone products, method of manufacture, and method of use ➤ Try a Free Trial
6,407,128 Method for increasing the bioavailability of metaxalone ➤ Try a Free Trial
6,683,102 Methods of using metaxalone in the treatment of musculoskeletal conditions ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
McKinsey
Daiichi Sankyo
Julphar
Cantor Fitzgerald
Merck
Johnson and Johnson
Medtronic
Colorcon

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.