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Express Scripts

Last Updated: August 10, 2020

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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 freedom to operate?

Metaxalone is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Amneal Pharms, Appco, Lannett Co Inc, Mountain, Primus Pharms, Sandoz, Sciegen Pharms Inc, and King Pharms, and is included in nine 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. Thirty 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

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Rothman Institute OrthopaedicsN/A
Montefiore Medical CenterPhase 4

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Pharmacology for METAXALONE
Paragraph IV (Patent) Challenges for METAXALONE
Tradename Dosage Ingredient NDA Submissiondate
SKELAXIN TABLET;ORAL metaxalone 013217 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   Start Trial   Start Trial   Start Trial
Sandoz METAXALONE metaxalone TABLET;ORAL 040445-001 Mar 31, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Amneal Pharms METAXALONE metaxalone TABLET;ORAL 203399-001 Jun 21, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Appco METAXALONE metaxalone TABLET;ORAL 208774-001 Sep 24, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-003 Aug 30, 2002 AB RX Yes Yes   Start Trial   Start Trial   Start 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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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson

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