mirabegron · Apgdi · NDA 202611
Myrbetriq
Earliest generic entry, as listed · earliest of 2 marketed strengths
28 Mar 2030
Blocked by patent: US 10842780, US 11707451, US 12059409, US 12097189.
Listed patents · 13 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10842780 | — | 28 Mar 2030 |
| US 11707451 | — | 28 Mar 2030 |
| US 12059409 | — | 28 Mar 2030 |
| US 12097189 | — | 28 Mar 2030 |
| US 10842780 | product, use U-2996 | 28 Sep 2029 |
| US 10842780 | product, use U-3670 | 28 Sep 2029 |
| US 11707451 | use U-3670 | 28 Sep 2029 |
| US 11707451 | use U-2996 | 28 Sep 2029 |
| US 12059409 | product | 28 Sep 2029 |
| US 12097189 | use U-2996 | 28 Sep 2029 |
| US 12097189 | use U-3670 | 28 Sep 2029 |
| US 8772315 | — | 30 Apr 2029 |
| US 8772315 | use U-2300 | 30 Oct 2028 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026Generic approved · 202611-0014 Nov 2025
- 25 Oct 2026Generic approved · 202611-0011 May 2026
- 25 Oct 2026Generic approved · 202611-0017 Oct 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202611 · 001 · RLD | tablet, extended release, oral | 25MG | 28 Mar 2030 |
| 202611 · 002 · RLD | tablet, extended release, oral | 50MG | 28 Mar 2030 |