SKELAXIN Drug Patent Profile

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 31^st, 2010.

Summary for SKELAXIN

International Patents:	2
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	105
Patent Applications:	3,052
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SKELAXIN
Drug Sales Revenues:	Drug sales revenues for SKELAXIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SKELAXIN
What excipients (inactive ingredients) are in SKELAXIN?	SKELAXIN excipients list
DailyMed Link:	SKELAXIN at DailyMed

See drug prices for SKELAXIN

See drug sales revenues for SKELAXIN

Pharmacology for SKELAXIN

Physiological Effect

Centrally-mediated Muscle Relaxation

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

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
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-003	Aug 30, 2002	AB	RX	Yes	Yes

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
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-001	Approved Prior to Jan 1, 1982
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-003	Aug 30, 2002
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-001	Approved Prior to Jan 1, 1982

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
Canada	2626027	PRODUITS A BASE DE METAXALONE, PROCEDE DE PREPARATION ET PROCEDE D'UTILISATION (METAXALONE PRODUCTS, METHOD OF MANUFACTURE, AND METHOD OF USE)