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  1. pharmadog
  2. ›drugs
  3. ›Myrbetriq
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mirabegron ER

Marketedupdated 3mo ago
by Astellas Pharma US Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 5
  • tagApproval8 co-mentions · 4 sources
  • tagSmall Molecule4 co-mentions · 4 sources
  • drugmirabegron SR4 co-mentions · 4 sources
  • drugMIRABEGRON4 co-mentions · 4 sources
  • companyLupin Ltd2 co-mentions · 2 sources

all catalysts(3)

approval · 3
Sep 28, 2022
approval
4y ago
MIRABEGRON — FDA approval
mirabegron ER
→
Nov 4, 2025
approval
10mo ago
MIRABEGRON — FDA approval
mirabegron ER
→
Dec 29, 2025
approval
8mo ago
MIRABEGRON — FDA approval
mirabegron ER
→

Trials studying mirabegron ER

  • phase3A Study to Learn How Effective and Safe the Drug 'Mirabegron' is and How Long it Stays in the Body of Children Aged 6 Months to Less Than 3 Years of Age With Neurogenic Detrusor Overactivityactive not recruitingn=7
  • phase4Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)completedn=888
  • phase3A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.completedn=1,887
  • phase3A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladdercompletedn=2,030
  • phase3Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladdercompletedn=2,336
  • phase3A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladdercompletedn=2,149
  • phase3Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladdercompletedn=2,792
  • phase4A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladdercompletedn=249
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Oct 30, 2028
~2.2 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (22)

  • Sep 30, 2036patentUS 10058536*PED
  • Mar 31, 2036formulationUS 10058536
  • Mar 28, 2030patentUS 10842780*PED3.6y
  • Mar 28, 2030patentUS 10842780*PED3.6y
  • Mar 28, 2030patentUS 11707451*PED3.6y
  • Mar 28, 2030patentUS 11707451*PED3.6y
  • Mar 28, 2030patentUS 12059409*PED3.6y
  • Mar 28, 2030patentUS 12059409*PED3.6y
  • Mar 28, 2030patentUS 12097189*PED3.6y
  • Mar 28, 2030patentUS 12097189*PED3.6y
  • Sep 28, 2029formulationUS 108427803.1y
  • Sep 28, 2029formulationUS 108427803.1y
  • Sep 28, 2029method-of-use (U-3670)US 117074513.1y
  • Sep 28, 2029method-of-use (U-3670)US 117074513.1y
  • Sep 28, 2029formulationUS 120594093.1y
  • Sep 28, 2029formulationUS 120594093.1y
  • Sep 28, 2029method-of-use (U-3670)US 120971893.1y
  • Sep 28, 2029method-of-use (U-3670)US 120971893.1y
  • Apr 30, 2029patentUS 8772315*PED2.7y
  • Apr 30, 2029patentUS 8772315*PED2.7y
  • Oct 30, 2028method-of-use (U-2300)US 87723152.2y
  • Oct 30, 2028method-of-use (U-2300)US 87723152.2y

News(0)

no news has mentioned this drug yet

brand
Myrbetriq
generic
mirabegron
indication
Neurogenic Bladder Dysfunction
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 23m ago
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