mirabegron Extended Release Oral Tablet

Brand(s)
Myrbetriq
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Fujisawa Healthcare, Inc. (2015-11-10)
Oldest Current Product
2012-06-28
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\MIRABEGRON
FDAOB
ORAL\TABLET, EXTENDED RELEASE\MIRABEGRON
SPL Active
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\MIRABEGRON
SPL Moiety
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\MIRABEGRON

product(s) by strength(s)

24 hr mirabegron 25 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004692601MyrbetriqNDAFujisawa Healthcare, Inc.2012-06-28MIRABEGRONORALTABLET, FILM COATED, EXTENDED RELEASENDA202611ba9e9e15-e666-4c56-9271-2e24739cfa2d

24 hr mirabegron 50 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004692602MyrbetriqNDAFujisawa Healthcare, Inc.2012-06-28MIRABEGRONORALTABLET, FILM COATED, EXTENDED RELEASENDA202611ba9e9e15-e666-4c56-9271-2e24739cfa2d

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202611MYRBETRIQASTELLAS PHARMA GLOBAL DEVELOPMENT INC2012-06-28pRE44872, FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE
p8835474, FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE
p7982049, SUBSTANCE
p7750029, TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE
p6562375, SUBSTANCE
p6346532, SUBSTANCE
p7342117
NEW CHEMICAL ENTITY [2017-06-28]NDA202611_001, NDA202611_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202611_001RXMIRABEGRON (25MG)ORALTABLET, EXTENDED RELEASEFalse2012-06-28MYRBETRIQ
2NDA202611_002RXMIRABEGRON (50MG)ORALTABLET, EXTENDED RELEASETrue2012-06-28MYRBETRIQ

patent(s)

#idexpiration dateapplication(s)
1p6346532 (view patent)2018-10-15NDA202611
2p6562375 (view patent)2020-08-01NDA202611
3p7342117 (view patent)2023-11-04NDA202611
4p7750029 (view patent)2023-12-18NDA202611
5p7982049 (view patent)2023-11-04NDA202611
6p8835474 (view patent)2023-11-04NDA202611
7pRE44872 (view patent)2023-12-18NDA202611

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1ba9e9e15-e666-4c56-9271-2e24739cfa2d (view SPL)These highlights do not include all the information needed to use MYRBETRIQ safely and effectively. See full prescribing information for MYRBETRIQ.MYRBETRIQ (mirabegron) extended-release tablets, for oral useInitial U.S. Approval: 2012prescriptionHuman PrescriptionFujisawa Healthcare, Inc.2015-11-105004692601, 004692602

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII