Orange Book product · Brand (NDA)
MYRBETRIQ
MIRABEGRON
At a glance
Jun 28, 2012
Approved
Brand (NDA)
Application
AB
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 28, 2012
14 yr 2 mo ago
Today
Patent 8772315 expires
Listed method-of-use patent (U-2300) expiration.
Oct 30, 2028
in 2 yr 5 mo
Patent 8772315*PED expires
Listed listed patent expiration.
Apr 30, 2029
in 2 yr 11 mo
Patent 10842780 expires
Listed drug product patent expiration.
Sep 28, 2029
in 3 yr 4 mo
Patent 10842780 expires
Listed drug product patent expiration.
Sep 28, 2029
in 3 yr 4 mo
Patent 11707451 expires
Listed method-of-use patent (U-2996) expiration.
Sep 28, 2029
in 3 yr 4 mo
Patent 11707451 expires
Listed method-of-use patent (U-3670) expiration.
Sep 28, 2029
in 3 yr 4 mo
Patent 12059409 expires
Listed drug product patent expiration.
Sep 28, 2029
in 3 yr 4 mo
Patent 12097189 expires
Listed method-of-use patent (U-2996) expiration.
Sep 28, 2029
in 3 yr 4 mo
Patent 12097189 expires
Listed method-of-use patent (U-3670) expiration.
Sep 28, 2029
in 3 yr 4 mo
Patent 10842780*PED expires
Listed listed patent expiration.
Mar 28, 2030
in 3 yr 10 mo
Patent 11707451*PED expires
Listed listed patent expiration.
Mar 28, 2030
in 3 yr 10 mo
Patent 12059409*PED expires
Listed listed patent expiration.
Mar 28, 2030
in 3 yr 10 mo
Patent 12097189*PED expires
Listed listed patent expiration.
Mar 28, 2030
in 3 yr 10 mo
Pharmaceutical detail
Active ingredient
MIRABEGRON
Strength
25MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 202611
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2021MYRBETRIQ GRANULESBrand (NDA)
NDA 213801 · APGDI
- 2026MIRABEGRONGeneric (ANDA)
ANDA 219941 · DEVA HOLDING AS
- 2026MIRABEGRONGeneric (ANDA)
ANDA 219323 · ALKEM LABS LTD
- 2025MIRABEGRONGeneric (ANDA)
ANDA 218543 · MSN
- 2025MIRABEGRONGeneric (ANDA)
ANDA 217989 · QILU
- 2025MIRABEGRONGeneric (ANDA)
ANDA 217061 · SAWAI USA
- 2025MIRABEGRONGeneric (ANDA)
ANDA 209434 · APOTEX
- 2024MIRABEGRONGeneric (ANDA)
ANDA 215948 · ALKEM LABS LTD
- 2022MIRABEGRONGeneric (ANDA)
ANDA 209488 · ZYDUS PHARMS
- 2022MIRABEGRONGeneric (ANDA)
ANDA 209485 · LUPIN
- 2019MIRABEGRONGeneric (ANDA)
ANDA 209446 · SAWAI USA
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8772315 | Oct 30, 2028 | in 2 yr 5 mo | U-2300 |
| 8772315*PED | Apr 30, 2029 | in 2 yr 11 mo | |
| 10842780 | Sep 28, 2029 | in 3 yr 4 mo | ProductU-3670 |
| 10842780 | Sep 28, 2029 | in 3 yr 4 mo | ProductU-2996 |
| 11707451 | Sep 28, 2029 | in 3 yr 4 mo | U-2996 |
| 11707451 | Sep 28, 2029 | in 3 yr 4 mo | U-3670 |
| 12059409 | Sep 28, 2029 | in 3 yr 4 mo | Product |
| 12097189 | Sep 28, 2029 | in 3 yr 4 mo | U-2996 |
| 12097189 | Sep 28, 2029 | in 3 yr 4 mo | U-3670 |
| 10842780*PED | Mar 28, 2030 | in 3 yr 10 mo | |
| 11707451*PED | Mar 28, 2030 | in 3 yr 10 mo | |
| 12059409*PED | Mar 28, 2030 | in 3 yr 10 mo | |
| 12097189*PED | Mar 28, 2030 | in 3 yr 10 mo |
