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SKELAXIN Drug Profile

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When do Skelaxin patents expire, and what generic alternatives are available?

Skelaxin is a drug marketed by King Pharms and is included in one NDA. There are two patents 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. Forty-one suppliers are listed for this compound. Additional details are available on the metaxalone profile page.

Summary for SKELAXIN

International Patents:	2
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	18
Bulk Api Vendors:	79
Patent Applications:	1,194
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SKELAXIN
DailyMed Link:	SKELAXIN at DailyMed

Pharmacology for SKELAXIN

Physiological Effect

Centrally-mediated Muscle Relaxation

Synonyms for SKELAXIN

.meta.Xalon

.meta.Xalone

.meta.Zalone

.meta.Zolone

105801-80-7

1665-48-1

2-Oxazolidinone, 5-((3,5-dimethylphenoxy)methyl)-

2-Oxazolidinone, 5-((3,5-xylyloxy)methyl)-

2-Oxazolidinone, 5-[(3,5-dimethylphenoxy)methyl]-

2-Oxazolidinone, 5-[(3,5-xylyloxy)methyl]-

2-Oxazolidinone,5-dimethylphenoxy)methyl]-

2-Oxazolidinone,5-xylyloxy)methyl]-

4CH-009638

5-((3,5-Dimethylphenoxy)methyl)-1,3-oxazolidin-2-one

5-((3,5-dimethylphenoxy)methyl)-2-oxazolidinon

5-((3,5-Dimethylphenoxy)methyl)-2-oxazolidinone

5-((3,5-Dimethylphenoxy)methyl)oxazolidin-2-one

5-((3,5-Xylyloxy)methyl)-2-oxazolidinone

5-(3,5-dimethylphenoxy)methyl-2-oxazolidinone

5-(3,5-dimethylphenoxymethyl)-1,3-oxazolidin-2-one

5-(3,5-dimethylphenoxymethyl)-2-oxazolidinone

5-(3,5-Xyloloxymethyl)oxazolidin-2-one

5-(3,5-xylyloxymethyl)-2-oxazolidone

5-[(3,5-Dimethylphenoxy)methyl]-1,3-oxazolidin-2-one

5-[(3,5-Dimethylphenoxy)methyl]-1,3-oxazolidin-2-one #

5-[(3,5-Dimethylphenoxy)methyl]-2-oxazolidinone

5-[(3,5-dimethylphenoxy)methyl]-4,5-dihydro-1,3-oxazol-2-ol

5-[(3,5-dimethylphenoxy)methyl]oxazolidin-2-one

5-[(3,5-Xylyloxy)methyl]-2-oxazolidinone

5-{[(3,5-dimethylphenyl)oxy]methyl}-1,3-oxazolidin-2-one

665M481

A810747

AB00053284_04

AB0063964

AC1L25XO

AC1Q6MIL

AHR 438

AHR-438

AK-61006

AKOS009035315

AM20060525

BC220747

BR-61006

BRD-A94709349-001-02-6

BRN 0884592

BSPBio_003451

C07934

CAS-1665-48-1

CCG-39592

CHEBI:6797

CHEMBL1079604

CL 39,148

CS-2910

CTK8F0377

D00773

D0S5CH

DB00660

DivK1c_006752

DR000428

DSSTox_CID_3269

DSSTox_GSID_23269

DSSTox_RID_76949

DTXSID3023269

EINECS 216-777-6

FS-3218

FT-0603568

GTPL7609

HE316934

HMS1922H07

HMS2093C22

HSDB 3236

HY-B0678

I06-0370

IMWZZHHPURKASS-UHFFFAOYSA-N

J-010295

KBio1_001696

KBio2_002221

KBio2_004789

KBio2_007357

KBio3_002671

KBioGR_001164

KBioSS_002221

KS-00000ZH8

LS-100704

M2578

MCULE-3101469866

Metassalone

Metassalone [DCIT]

Metaxalon

Metaxalona

Metaxalona [INN-Spanish]

Metaxalona [Spanish]

METAXALONE

Metaxalone (USAN/INN)

Metaxalone [USAN:INN:BAN]

Metaxalone, >=98% (HPLC)

Metaxalone, United States Pharmacopeia (USP) Reference Standard

Metaxalonum

Metaxalonum [INN-Latin]

Metaxalonum [Latin]

Metaxolone

Metazalone

Metazolone

Methaxalonum

Methoxolone

MFCD00867700

MLS003106749

MolPort-003-666-548

NCGC00095116-01

NCGC00095116-02

NCGC00095116-03

NCGC00095116-05

NSC 170959

NSC-170959

NSC-758703

NSC170959

NSC758703

Oprea1_438855

Pharmakon1600-01504229

S-2010

SBI-0052859.P002

SCHEMBL34908

Skelaxin (TN)

SMR001821638

SPBio_000595

SpecPlus_000656

Spectrum_001741

SPECTRUM1504229

Spectrum2_000548

Spectrum3_001666

Spectrum4_000612

Spectrum5_001685

SR-05000001978

SR-05000001978-3

ST24029254

STL450994

STL451511

Tox21_111428

Tox21_111428_1

TR-035874

TRA0047745

WLN: T5MVOTJ D1OR C1 E1

Zorane

US Patents and Regulatory Information for 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
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-003	Aug 30, 2002	AB	RX	Yes	Yes

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Paragraph IV (Patent) Challenges for SKELAXIN

Drugname	Dosage	Strength	RLD	Submissiondate
	Tablets	800 mg		2004-11-04

Non-Orange Book US Patents for SKELAXIN

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,378,434	Metaxalone products, method of manufacture, and method of use
6,407,128	Method for increasing the bioavailability of metaxalone
8,168,664	Metaxalone products, method of manufacture, and method of use
6,683,102	Methods of using metaxalone in the treatment of musculoskeletal conditions

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International Patents for SKELAXIN

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007094825
Canada	2626027