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Last Updated: June 1, 2024

METAXALONE - Generic Drug Details

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What are the generic sources for metaxalone and what is the scope of freedom to operate?

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 are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Metaxalone has eight patent family members in seven countries.

There are twenty drug master file entries for metaxalone. Thirty-three suppliers are listed for this compound.

Summary for METAXALONE

International Patents:	8
US Patents:	2
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	2
Patent Applications:	3,880
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends 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

See drug prices for METAXALONE

Drug Sales Revenue Trends 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

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Glossary

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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
Primus Pharms	METAXALONE	metaxalone	TABLET;ORAL	022503-001	Jun 1, 2015		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Appco	METAXALONE	metaxalone	TABLET;ORAL	208774-001	Sep 24, 2018	BX	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Fl Inc	METAXALONE	metaxalone	TABLET;ORAL	203695-001	Jun 15, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sciegen Pharms Inc	METAXALONE	metaxalone	TABLET;ORAL	207466-001	Aug 31, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-003	Aug 30, 2002		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mountain	METAXALONE	metaxalone	TABLET;ORAL	040486-001	Feb 27, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 METAXALONE

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

International Patents for METAXALONE

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2020263768		⤷ 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
South Korea	20220025815	용량이 감소된 메탁살론 제형	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2007094825		⤷ Sign Up
Japan	2022539368	低用量のメタキサロン製剤	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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