Last Updated: June 18, 2026

Details for New Drug Application (NDA): 022503


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NDA 022503 describes METAXALONE, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Ingenus Pharms Llc, Lannett Co Inc, Mountain, Primus Pharms, Rising, Sandoz, and Sciegen Pharms, and is included in nine NDAs. It is available from thirty-four suppliers. There are two patents protecting this drug. Additional details are available on the METAXALONE profile page.

The generic ingredient in METAXALONE is metaxalone. There are twenty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the metaxalone profile page.
Summary for 022503
Tradename:METAXALONE
Applicant:Primus Pharms
Ingredient:metaxalone
Patents:2
Pharmacology for NDA: 022503
Physiological EffectCentrally-mediated Muscle Relaxation
Suppliers and Packaging for NDA: 022503
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METAXALONE metaxalone TABLET;ORAL 022503 NDA INA Pharmaceutics Inc 74157-018 74157-018-60 60 TABLET in 1 BOTTLE (74157-018-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 1, 2015TE:RLD:Yes
Patent:⤷  Start TrialPatent Expiration:Jul 29, 2039Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Start TrialPatent Expiration:May 14, 2043Product Flag?YSubstance Flag?Delist Request?
Patented Use:METAXALONE IS INDICATED AS AN ADJUNCT TO REST, PHYSICAL THERAPY, AND OTHER MEASURES FOR THE RELIEF AND DISCOMFORT ASSOCIATED WITH ACUTE, PAINFUL MUSCULOSKELETAL CONDITIONS

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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