Orange Book product · Brand (NDA)

MYRBETRIQ GRANULES

MIRABEGRON

Brand (NDA)NDA 213801TE ABRX APGDI

Mar 25, 2021

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 25, 2021
5 yr 4 mo ago
Today
Patent 10058536 expires
Listed drug product patent expiration.
Mar 31, 2036
in 9 yr 11 mo
Patent 10058536*PED expires
Listed listed patent expiration.
Sep 30, 2036
in 10 yr 5 mo

Active ingredient

MIRABEGRON

Strength

8MG/ML

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

ORAL

TE code

Application

NDA 213801

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10058536	Mar 31, 2036	in 9 yr 11 mo	ProductU-3108
10058536*PED	Sep 30, 2036	in 10 yr 5 mo