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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-three patent family members in twenty-six countries.

There are three 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 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

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

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)

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

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, 2012RXYes7,750,029<disabled><disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXNo8,835,474<disabled><disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXNoRE44872<disabled><disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYes<disabled><disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYes6,562,375<disabled>Y<disabled>
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International Patent Family for Ingredient: mirabegron

Country Document Number Publication Date
South Korea100506568Apr 21, 2006
Norway326965Mar 23, 2009
Russian Federation2321401Apr 10, 2008
Hungary0202495Nov 28, 2002
Hungary9802417Dec 28, 1998
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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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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