testosterone cypionate · Azurity · NDA 216318
Azmiro
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 11311554, US 11642355, US 12138271.
FDA has approved 1 generic application (ANDA) for Azmiro, though its earliest generic-entry date is 25 Mar 2039 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 · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11311554 | product | 25 Mar 2039 |
| US 11642355 | product | 25 Mar 2039 |
| US 12138271 | product | 25 Mar 2039 |
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 2026First generic approved · 216318-0013 Sep 2026
- 25 Oct 2026Generic approved · 216318-0013 Sep 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216318 · 001 · RLD · discontinued | solution, intramuscular | 200MG/ML (200MG/ML) | 25 Mar 2039 |