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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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: mirabegron

Tradenames:1
Patents:8
Applicants:1
NDAs:1
Drug Master File Entries: see list3
Suppliers: see list1

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

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)

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

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 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

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

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

A Study to Investigate the Safety and Effect of Food on the Pharmacokinetics of YM178 in Healthy Volunteers
Status: Completed Condition: Healthy Volunteer; Pharmacokinetics of YM178

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
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;ORAL202611Jun 28, 2012RXYes<disabled><disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611Jun 28, 2012RXNo6,562,375<disabled>Y<disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611Jun 28, 2012RXNo6,346,532<disabled>YY<disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611Jun 28, 2012RXNo6,699,503<disabled>Y<disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611Jun 28, 2012RXNo7,342,117<disabled>Y<disabled>
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