Drug facts

Molecule

Mirabegron (Myrbetriq)

Generics already compete: 7 makers on the market. 15 A-rated products from 7 makers substitute at the counter.

Myrbetriq was first approved by the FDA on 06/28/2012 under NDA 202611; the application holder is Astellas Pharma Global Development Inc.

The latest NADAC for MIRABEGRON ER 25 MG TABLET is $9.02 per unit (as of 10/28/2026).

Holder Astellas Pharma Global Development IncApplication NDA 202611Approved 06/28/2012
Open full profileStart free trial

Data as of 10/30/2026

Market protection3 yr 4 moLatest Myrbetriq patent 03/28/2030Generics7 makers2 staged, awaiting entryFDA shortageClearNot listedCurrent FDA listNADAC$9.02 / unitAs of 10/28/2026

01Patents and exclusivity

When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.

1,245days until the latest Myrbetriq patent expires

ExclusivityPatent onlyOpen to generics
Today
Approved06/28/2012
Last patent03/28/2030
2013201620192022202520282031
Latest patent
03/28/2030Myrbetriq
Orange Book
Later patents, other products
Myrbetriq Granules 09/30/2036
Orange Book

02Competition

Generics
7 generic makers
Orange Book
Staged generics
2 passed FDA review, awaiting market entry
FDA
First generic approved
12/27/2019
Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Mirabegron profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages
NADAC
$9.02 per unitMIRABEGRON ER 25 MG TABLET, as of 10/28/2026
CMS NADAC
Latest recall
08/05/2026Class II, Mirabegron, Zydus Pharmaceuticals (USA) Inc
FDA enforcement

04Product

Application holder
Astellas Pharma Global Development Inc
Orange Book
Application
NDA 202611
Orange Book
First approved
06/28/2012
Orange Book
Dosage forms
for suspension, extended release; tablet, extended release
Routes
oral
Other brand names
Myrbetriq Granules

Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.