METAXALONE Drug Patent Profile

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Metaxalone is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Ingenus Pharms Llc, Lannett Co Inc, Mountain, Primus Pharms, Rising, Sandoz, and Sciegen Pharms Inc. and is included in nine NDAs. There is one patent protecting this drug.

This drug has six patent family members in six countries.

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

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

International Patents:	6
US Patents:	1
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	3
Patent Applications:	2,531
Drug Prices:	Drug price information for METAXALONE
Drug Sales Revenues:	Drug sales revenues for METAXALONE
What excipients (inactive ingredients) are in METAXALONE?	METAXALONE excipients list
DailyMed Link:	METAXALONE at DailyMed

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

Sponsor	Phase
Primus Pharmaceuticals	Phase 4
Illumination Health	Phase 4
Rothman Institute Orthopaedics	N/A

Drug Class	Muscle Relaxant
Physiological Effect	Centrally-mediated Muscle Relaxation

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SKELAXIN	Tablets	metaxalone	800 mg	013217	1	2004-11-04

METAXALONE is protected by one US patents.

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Labs Fl Inc	METAXALONE	metaxalone	TABLET;ORAL	203695-001	Jun 15, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	METAXALONE	metaxalone	TABLET;ORAL	208774-001	Sep 24, 2018	BX	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lannett Co Inc	METAXALONE	metaxalone	TABLET;ORAL	204770-001	Nov 22, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	METAXALONE	metaxalone	TABLET;ORAL	040445-001	Mar 31, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	METAXALONE	metaxalone	TABLET;ORAL	203399-001	Jun 21, 2013	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ingenus Pharms Llc	METAXALONE	metaxalone	TABLET;ORAL	213836-001	Oct 21, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Primus Pharms	METAXALONE	metaxalone	TABLET;ORAL	022503-001	Jun 1, 2015		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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

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Country	Patent Number	Title	Estimated Expiration
South Korea	20220025815	용량이 감소된 메탁살론 제형	⤷ Sign Up
Brazil	112021026371	Formulações de metaxalona de dose reduzida	⤷ Sign Up
European Patent Office	3989946	FORMULATIONS DE MÉTAXALONE À DOSE RÉDUITE (REDUCED DOSE METAXALONE FORMULATIONS)	⤷ Sign Up
Australia	2020307390	Reduced dose metaxalone formulations	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2020263768		⤷ Sign Up
Japan	2022539368	低用量のメタキサロン製剤	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration