mirabegron · Apgdi · NDA 213801
Myrbetriq Granules
Blocked by patent: US 10058536 (pediatric extension).
FDA has approved 1 generic application (ANDA) for Myrbetriq Granules, though its earliest generic-entry date is 30 Sep 2036 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 · 1 unexpired
2 Orange Book listing rows for 1 patent, including 1 pediatric extension. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10058536 | drug product, use U-3108 | 30 Sep 2036 |
| US 10058536 listing row | drug product, use U-3108 | 31 Mar 2036 |
| US 10058536 listing row | pediatric extension · sets the listed date | 30 Sep 2036 |
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
- First generic approved · ANDA 219323, Alkem Labs Ltd · 213801-001Approved 20 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219323, Alkem Labs Ltd · 213801-001Approved 20 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213801 · 001 · RLD | for suspension, extended release, oral | 8MG/ML | 30 Sep 2036 |