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Myrbetriq · pharmadog

pharmadog
drugs
Myrbetriq

drug

patient view →

mirabegron ER

Marketedupdated 2mo ago

by Astellas Pharma US Inc

Approved

community read0 votes

all catalysts(3)

approval · 3

MIRABEGRON — FDA approval

MIRABEGRON — FDA approval

MIRABEGRON — FDA approval

News(0)

no news has mentioned this drug yet

brand

Myrbetriq

generic

mirabegron

indication

Neurogenic Bladder Dysfunction

phase

marketed

comments(0)

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no comments yet — first sniff?

Data sources

openFDA · ClinicalTrials.gov

last refreshed just now

Found something off?

🐶 something off?

Report a data issue

Tell Bork what looks wrong — wrong sponsor, stale phase, mislinked ticker, anything. We’ll triage and fix.

Patent cliff

source: FDA Orange Book

first barrier falls

Oct 30, 2028

~2.3 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*PED3.7y
Mar 28, 2030patentUS 10842780*PED3.7y
Mar 28, 2030patentUS 11707451*PED3.7y
Mar 28, 2030patentUS 11707451*PED3.7y
Mar 28, 2030patentUS 12059409*PED3.7y
Mar 28, 2030patentUS 12059409*PED3.7y
Mar 28, 2030patentUS 12097189*PED3.7y
Mar 28, 2030patentUS 12097189*PED3.7y
Sep 28, 2029formulationUS 108427803.2y
Sep 28, 2029formulationUS 108427803.2y
Sep 28, 2029method-of-use (U-3670)US 117074513.2y
Sep 28, 2029method-of-use (U-3670)US 117074513.2y
Sep 28, 2029formulationUS 120594093.2y
Sep 28, 2029formulationUS 120594093.2y
Sep 28, 2029method-of-use (U-3670)US 120971893.2y
Sep 28, 2029method-of-use (U-3670)US 120971893.2y
Apr 30, 2029patentUS 8772315*PED2.8y
Apr 30, 2029patentUS 8772315*PED2.8y
Oct 30, 2028method-of-use (U-2300)US 87723152.3y
Oct 30, 2028method-of-use (U-2300)US 87723152.3y

🐶 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

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 →