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Serving leading biopharmaceutical companies globally:

Chubb
Dow
Farmers Insurance
Healthtrust
Citi
Moodys
Merck
Cerilliant
Novartis
UBS

Generated: February 21, 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 Holdings 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-one suppliers are listed for this compound.
Summary for metaxalone
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
Mountain METAXALONE metaxalone TABLET;ORAL 040486-001 Feb 27, 2015 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lannett Holdings Inc METAXALONE metaxalone TABLET;ORAL 204770-001 Nov 22, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz METAXALONE metaxalone TABLET;ORAL 040445-001 Mar 31, 2010 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sciegen Pharms Inc METAXALONE metaxalone TABLET;ORAL 207466-001 Aug 31, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amneal Pharms METAXALONE metaxalone TABLET;ORAL 203399-001 Jun 21, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Primus Pharms METAXALONE metaxalone TABLET;ORAL 022503-001 Jun 1, 2015 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-003 Aug 30, 2002 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-003 Aug 30, 2002 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-001 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Labs Fl Inc METAXALONE metaxalone TABLET;ORAL 203695-001 Jun 15, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 ➤ Sign Up
6,683,102 Methods of using metaxalone in the treatment of musculoskeletal conditions ➤ Sign Up
8,168,664 Metaxalone products, method of manufacture, and method of use ➤ Sign Up
6,407,128 Method for increasing the bioavailability of metaxalone ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Daiichi Sankyo
Johnson and Johnson
AstraZeneca
QuintilesIMS
UBS
Moodys
McKinsey
Fuji

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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