Metaxalone - Generic Drug Details

What are the generic drug sources for metaxalone and what is the scope of patent protection?

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 is one patent 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-seven suppliers are listed for this compound.

Summary for metaxalone

International Patents:	2
US Patents:	1
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	2
Patent Applications:	4,558
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for metaxalone
What excipients (inactive ingredients) are in metaxalone?	metaxalone excipients list
DailyMed Link:	metaxalone at DailyMed

See drug prices for metaxalone

See drug sales revenues for metaxalone

Recent Clinical Trials for metaxalone

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

Sponsor	Phase
Rothman Institute Orthopaedics	N/A
Montefiore Medical Center	Phase 4

See all metaxalone clinical trials

Pharmacology for metaxalone

Drug Class	Muscle Relaxant
Physiological Effect	Centrally-mediated Muscle Relaxation

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
Sandoz	METAXALONE	metaxalone	TABLET;ORAL	040445-001	Mar 31, 2010	AB	RX	No	No
Ingenus Pharms Llc	METAXALONE	metaxalone	TABLET;ORAL	213836-001	Oct 21, 2020		DISCN	No	No
Primus Pharms	METAXALONE	metaxalone	TABLET;ORAL	022503-001	Jun 1, 2015		DISCN	Yes	No
Actavis Labs Fl Inc	METAXALONE	metaxalone	TABLET;ORAL	203695-001	Jun 15, 2017	AB	RX	No	No
Lannett Co Inc	METAXALONE	metaxalone	TABLET;ORAL	204770-001	Nov 22, 2016	AB	RX	No	No
Mountain	METAXALONE	metaxalone	TABLET;ORAL	040486-001	Feb 27, 2015	AB	RX	No	No
Sciegen Pharms Inc	METAXALONE	metaxalone	TABLET;ORAL	207466-001	Aug 31, 2017	AB	RX	No	No

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

International Patents for metaxalone

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