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Last Updated: May 19, 2022

SKELAXIN Drug Patent 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 is one patent 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-one suppliers are listed for this compound. Additional details are available on the metaxalone profile page.

DrugPatentWatch® 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 Strength NDA ANDAs Submitted Submissiondate
SKELAXIN Tablets metaxalone 800 mg 013217 1 2004-11-04

US Patents and Regulatory Information for SKELAXIN

SKELAXIN is protected by one US patents.

Patents protecting SKELAXIN

Metaxalone products, method of manufacture, and method of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MUSCULOSKELETAL CONDITIONS

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-003 Aug 30, 2002 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 SKELAXIN

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

International Patents for SKELAXIN

See the table below for patents covering SKELAXIN around the world.

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

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Serving leading biopharmaceutical companies globally:

McKesson
Baxter
AstraZeneca
Medtronic
Merck
Mallinckrodt

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