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Last Updated: February 18, 2020

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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. Twenty-nine suppliers are listed for this compound. Additional details are available on the metaxalone profile page.

US ANDA Litigation and Generic Entry Outlook for Skelaxin

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

  Start Trial

Drug patent expirations by year for SKELAXIN
Drug Prices for SKELAXIN

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Drug Sales Revenue Trends for SKELAXIN

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Recent Litigation for SKELAXIN

Identify potential future generic entrants

District Court Litigation
Case NameDate
KING PHARMACEUTICALS, INC. v. SANDOZ INC.2008-12-05
Santilli v. Classen Immunotherapies Inc.2005-10-24
King Pharmaceuticals, Inc v. EON Labs, Inc.2004-12-17

See all SKELAXIN litigation

Pharmacology for SKELAXIN
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-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
AKOS009035315
AM20060525
BC220747
BCP28377
BR-61006
BRD-A94709349-001-02-6
BRD-A94709349-001-03-4
BRN 0884592
BSPBio_003451
C07934
CAS-1665-48-1
CCG-39592
CHEBI:6797
CHEMBL1079604
CL 39,148
CS-2910
CTK8F0377
D00773
DB00660
DivK1c_006752
DSSTox_CID_3269
DSSTox_GSID_23269
DSSTox_RID_76949
DTXSID3023269
EINECS 216-777-6
FS-3218
FT-0603568
GTPL7609
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 solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
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-05000001978-1
SR-05000001978-3
ST24029254
STL450994
STL451511
Tox21_111428
Tox21_111428_1
TR-035874
TRA0047745
WLN: T5MVOTJ D1OR C1 E1
Zorane
Paragraph IV (Patent) Challenges for SKELAXIN
Tradename Dosage Ingredient NDA Submissiondate
SKELAXIN TABLET;ORAL metaxalone 013217 2004-11-04

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   Start Trial   Start Trial   Start Trial
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-003 Aug 30, 2002 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
King Pharms SKELAXIN metaxalone TABLET;ORAL 013217-003 Aug 30, 2002 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Express Scripts
Medtronic
Merck
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.