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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-three patent family members in twenty-six countries.

The generic ingredient in MYRBETRIQ is mirabegron. There are three 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: see list1

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: Recruiting Condition: Overactive Bladder (OAB)

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

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

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 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

A Study to Assess Pharmacokinetic Interaction of Multiple Dose Ketoconazole on Single Dose YM178 Oral Controlled Absorption System (OCAS) in Healthy Adult Volunteers
Status: Completed Condition: Healthy Subjects; 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;ORAL202611-002Jun 28, 2012RXYesRE44872<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, 2012RXNo8,835,474<disabled><disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYes7,342,117<disabled>Y<disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXNo6,562,375<disabled>Y<disabled>
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International Patent Family for Tradename: MYRBETRIQ

Country Document Number Publication Date
Australia769807Feb 05, 2004
MexicoPA02001267Aug 12, 2002
Spain2262528Dec 01, 2006
Russian Federation2005117367Jan 20, 2006
Portugal1559427May 27, 2011
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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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