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, Ingenus Pharms Llc, Lannett Co Inc, Mountain, Primus Pharms, Rising, 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-four 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:	34
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	3
Patent Applications:	3,659
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
Primus Pharmaceuticals	Phase 4
Illumination Health	Phase 4
Rothman Institute Orthopaedics	N/A

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
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-001	Approved Prior to Jan 1, 1982		DISCN	Yes	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
Sciegen Pharms Inc	METAXALONE	metaxalone	TABLET;ORAL	207466-002	Mar 13, 2020	AB	RX	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

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	013217-001	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	013217-003	Aug 30, 2002	⤷ 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)	2007094825		⤷ Sign Up
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
>Country	>Patent Number	>Title	>Estimated Expiration

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