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Last Updated: July 18, 2024

METAXALONE - Generic Drug Details


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What are the generic sources for metaxalone and what is the scope of freedom to operate?

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 are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Metaxalone has eight patent family members in seven countries.

There are twenty drug master file entries for metaxalone. Thirty-three suppliers are listed for this compound.

Drug Prices for METAXALONE

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Drug Sales Revenue Trends for METAXALONE

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Recent Clinical Trials for METAXALONE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Rothman Institute OrthopaedicsN/A
Montefiore Medical CenterPhase 4

See all METAXALONE clinical trials

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
Sciegen Pharms Inc METAXALONE metaxalone TABLET;ORAL 207466-002 Mar 13, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ingenus Pharms Llc METAXALONE metaxalone TABLET;ORAL 213836-001 Oct 21, 2020 DISCN No No ⤷  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
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-003 Aug 30, 2002 DISCN Yes 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

Expired US Patents for METAXALONE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-003 Aug 30, 2002 ⤷  Sign Up ⤷  Sign Up
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-003 Aug 30, 2002 ⤷  Sign Up ⤷  Sign Up
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-003 Aug 30, 2002 ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up
Brazil 112021026371 Formulações de metaxalona de dose reduzida ⤷  Sign Up
Canada 2626027 PRODUITS A BASE DE METAXALONE, PROCEDE DE PREPARATION ET PROCEDE D'UTILISATION (METAXALONE PRODUCTS, METHOD OF MANUFACTURE, AND METHOD OF USE) ⤷  Sign Up
European Patent Office 3989946 FORMULATIONS DE MÉTAXALONE À DOSE RÉDUITE (REDUCED DOSE METAXALONE FORMULATIONS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.