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Details for Generic Name: mirabegron

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Mirabegron is the generic ingredient in one branded drug marketed by Apgdi and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has ninety-five patent family members in twenty-seven countries.

There are four drug master file entries for mirabegron. One supplier is listed for this compound.

Summary for Generic Name: mirabegron

Tradenames:1
Patents:7
Applicants:1
NDAs:1
Drug Master File Entries: see list4
Suppliers / Packaging: see list6

Pharmacology for Ingredient: mirabegron

Clinical Trials for: mirabegron

Pharmacokinetics of Oral Mirabegron With Different Release Rates Versus Intravenous (IV) Mirabegron
Status: Completed Condition: Healthy; Pharmacokinetics of Mirabegron

Pilot Study of Mirabegron in Pediatric Patients With Overactive Bladder
Status: Active, not recruiting Condition: Overactive Bladder; Urinary Incontinence

Study to Evaluate the Effect of Solifenacin and Mirabegron on the Digoxin Concentrations in Blood in Healthy Subjects
Status: Completed Condition: Healthy Subjects; Pharmacokinetics; Drug-Drug Interaction (DDI)

Add-on Mirabegron in Pediatric Patients With Refractory Overactive Bladder
Status: Enrolling by invitation Condition: Overactive Bladder; Urinary Incontinence

Pharmacokinetic Interaction Study to Assess the Effect of Repeat Doses of Rifampin on Mirabegron (YM178) in Healthy Volunteers
Status: Completed Condition: Pharmacokinetics of YM178

A Study to Find Out How Much Mirabegron Gets Into the Body After Dosing With a Tablet Formulation
Status: Completed Condition: Pharmacokinetics of Mirabegron; Bioavailability; Healthy Subjects

Study of the Effect of Food on the Pharmacokinetics of Mirabegron
Status: Completed Condition: Healthy; Pharmacokinetics of Mirabegron

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder
Status: Recruiting Condition: Pharmacokinetics of Mirabegron; Neurogenic Detrusor Overactivity; Overactive Bladder

To Evaluate the Effect of Mirabegron (YM178) on Blood Levels of Desipramine When They Are Taken Together
Status: Completed Condition: Pharmacokinetics of Mirabegron; Healthy Subjects

A Clinical Study to Assess the Effect on Pharmacokinetics of Dosing Mirabegron (YM178) and Solifenacin Simultaneously
Status: Completed Condition: Healthy Volunteers; Pharmacokinetics of Mirabegron

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXNo6,562,375<disabled>Y<disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYes6,346,532<disabled>YY<disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYes7,982,049<disabled>Y<disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYes7,342,117<disabled>Y<disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYesRE44872<disabled><disabled>
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International Patent Family for Ingredient: mirabegron

Country Document Number Publication Date
TaiwanI322805Apr 01, 2010
South Africa200503510Dec 27, 2006
European Patent Office1559427May 30, 2007
Taiwan557295Oct 11, 2003
South Korea100506568Apr 21, 2006
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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