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Last Updated: March 28, 2024

Metaxalone - Generic Drug Details


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

Metaxalone is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Amneal Pharms, Appco, Ingenus Pharms Llc, Lannett Co Inc, Mountain, Primus Pharms, Sandoz, Sciegen Pharms Inc, and King Pharms, and is included in ten NDAs. There is one patent 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. Thirty-three suppliers are listed for this compound.

Summary for metaxalone
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Drug Sales Revenue Trends for metaxalone

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Recent Clinical Trials for metaxalone

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SponsorPhase
Rothman Institute OrthopaedicsN/A
Montefiore Medical CenterPhase 4

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Pharmacology for metaxalone
Paragraph IV (Patent) Challenges for METAXALONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SKELAXIN Tablets metaxalone 800 mg 013217 1 2004-11-04

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 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Appco METAXALONE metaxalone TABLET;ORAL 208774-001 Sep 24, 2018 BX RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms METAXALONE metaxalone TABLET;ORAL 203399-001 Jun 21, 2013 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lannett Co Inc METAXALONE metaxalone TABLET;ORAL 204770-001 Nov 22, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz METAXALONE metaxalone TABLET;ORAL 040445-001 Mar 31, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Primus Pharms METAXALONE metaxalone TABLET;ORAL 022503-001 Jun 1, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ingenus Pharms Llc METAXALONE metaxalone TABLET;ORAL 213836-001 Oct 21, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for metaxalone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-003 Aug 30, 2002 ⤷  Try a Trial ⤷  Try a Trial
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-003 Aug 30, 2002 ⤷  Try a Trial ⤷  Try a Trial
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-003 Aug 30, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for metaxalone

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2007094825 ⤷  Try a Trial
Canada 2626027 PRODUITS A BASE DE METAXALONE, PROCEDE DE PREPARATION ET PROCEDE D'UTILISATION (METAXALONE PRODUCTS, METHOD OF MANUFACTURE, AND METHOD OF USE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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