mirabegron · Apgdi · NDA 202611
Myrbetriq
Blocked by patent: US 10842780 (pediatric extension), US 11707451 (pediatric extension), US 12059409 (pediatric extension), US 12097189 (pediatric extension).
FDA has approved 3 generic applications (ANDAs) for Myrbetriq, though its earliest generic-entry date is 28 Mar 2030 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 5 unexpired
13 Orange Book listing rows for 5 patents, including 5 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10842780 | drug product, use U-2996, U-3670 | 28 Mar 2030 |
| US 10842780 listing row | drug product, use U-2996 | 28 Sep 2029 |
| US 10842780 listing row | drug product, use U-3670 | 28 Sep 2029 |
| US 10842780 listing row | pediatric extension · sets the listed date | 28 Mar 2030 |
| US 11707451 | use U-2996, U-3670 | 28 Mar 2030 |
| US 11707451 listing row | use U-2996 | 28 Sep 2029 |
| US 11707451 listing row | use U-3670 | 28 Sep 2029 |
| US 11707451 listing row | pediatric extension · sets the listed date | 28 Mar 2030 |
| US 12059409 | drug product | 28 Mar 2030 |
| US 12059409 listing row | drug product | 28 Sep 2029 |
| US 12059409 listing row | pediatric extension · sets the listed date | 28 Mar 2030 |
| US 12097189 | use U-2996, U-3670 | 28 Mar 2030 |
| US 12097189 listing row | use U-2996 | 28 Sep 2029 |
| US 12097189 listing row | use U-3670 | 28 Sep 2029 |
| US 12097189 listing row | pediatric extension · sets the listed date | 28 Mar 2030 |
| US 8772315 | use U-2300 | 30 Apr 2029 |
| US 8772315 listing row | use U-2300 | 30 Oct 2028 |
| US 8772315 listing row | pediatric extension | 30 Apr 2029 |
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
- Generic approved · ANDA 218543, Msn · 202611-001Approved 4 Nov 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219941, Deva Holding As · 202611-001Approved 1 May 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219599, Creekwood Pharms · 202611-001Approved 7 Oct 2026Detected 25 Oct 2026Historical import
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 |