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FDA Orange Book · active-ingredient family

Metaxalone

Metaxalone is approved as 2 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:METAXALONE · NDA 022503

2

Brand (NDA)

8

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
METAXALONERLDPRIMUS PHARMSNDA 022503—Jun 01, 2015
SKELAXINRLD×2KING PHARMSNDA 013217—Approved Prior to Jan 1, 1982

Generic (ANDA) products (8)

ProductApplicantApplicationTEApproved
METAXALONEINGENUS PHARMS LLCANDA 213836—Oct 21, 2020
METAXALONE×2SCIEGEN PHARMSANDA 207466ABMar 13, 2020
METAXALONERISINGANDA 208774—Sep 24, 2018
METAXALONEACTAVIS LABS FL INCANDA 203695ABJun 15, 2017
METAXALONELANNETT CO INCANDA 204770ABNov 22, 2016
METAXALONEMOUNTAINANDA 040486ABFeb 27, 2015
METAXALONEAMNEAL PHARMSANDA 203399ABJun 21, 2013
METAXALONESANDOZANDA 040445ABMar 31, 2010

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7122566Feb 06, 20264 mo ago
U-915
11918559Jul 29, 2039in 13 yr 4 mo
Product
12485111May 14, 2043in 17 yr 2 mo
ProductU-4453

Metaxalone — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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