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Profile for Tradename: MYRBETRIQ

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Myrbetriq is a drug marketed by Apgdi and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug.

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

The generic ingredient in MYRBETRIQ is mirabegron. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mirabegron profile page.

Summary for Tradename: MYRBETRIQ

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list6

Pharmacology for Tradename: MYRBETRIQ

Clinical Trials for: MYRBETRIQ

A Study to Evaluate Tolerability and Patient Preference Between Myrbetriq® and Detrol® LA in Subjects With Overactive Bladder (OAB)
Status: Active, not recruiting Condition: Overactive Bladder (OAB)

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

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 5 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)
Status: Not yet recruiting Condition: Neurogenic Detrusor Overactivity; Overactive Bladder

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

Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Status: Completed Condition: Urinary Bladder, Overactive

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

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, 2012RXNoRE44872<disabled><disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXNo6,346,532<disabled>YY<disabled>
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;ORAL202611-001Jun 28, 2012RXNo<disabled><disabled>
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International Patent Family for Tradename: MYRBETRIQ

Country Document Number Publication Date
Poland200645Jan 30, 2009
Norway20020516Feb 01, 2002
China1136193Jan 28, 2004
European Patent Office2298752Mar 23, 2011
Poland218982Feb 27, 2015
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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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