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Last Updated: July 6, 2020

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SKELAXIN Drug Profile


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When do Skelaxin patents expire, and when can generic versions of Skelaxin launch?

Skelaxin is a drug marketed by King Pharms and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has two patent family members in two countries.

The generic ingredient in SKELAXIN is metaxalone. There are twenty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the metaxalone profile page.

US ANDA Litigation and Generic Entry Outlook for Skelaxin

A generic version of SKELAXIN was approved as metaxalone by SANDOZ on March 31st, 2010.

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Paragraph IV (Patent) Challenges for SKELAXIN
Tradename Dosage Ingredient NDA Submissiondate
SKELAXIN TABLET;ORAL metaxalone 013217 2004-11-04

US Patents and Regulatory Information for SKELAXIN

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 013217-001 Approved Prior to Jan 1, 1982 DISCN Yes 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
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:

McKesson
Baxter
AstraZeneca
Medtronic
Merck
Mallinckrodt

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