cyclosporine · Harrow Eye · NDA 214965
Verkazia
Earliest generic entry, as listed
2 Jun 2029
Blocked by patent: US 9132071.
FDA has approved 3 generic applications (ANDAs) for Verkazia, though its earliest generic-entry date is 2 Jun 2029 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 · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9132071 | drug product · sets the listed date | 2 Jun 2029 |
| US 8298568 | drug product | 3 Nov 2027 |
Exclusivities · 1 unexpired
| ODE-358 | orphan drug (7 years) | 23 Jun 2028 |
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 211909, Amneal · 214965-001Approved 28 Nov 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219288, Jiangsu Anbison · 214965-001Approved 1 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 209064, Twi Pharms · 214965-001Approved 21 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214965 · 001 · RLD | emulsion, ophthalmic | 0.1% | 2 Jun 2029 |
Expired or delisted (5)
- US 11612658 · use U-3560 · 27 Jan 2026
- US 7973081 · product · 27 Jan 2026
- US 8524779 · product · 27 Jan 2026
- US 9220694 · product · 27 Jan 2026
- US 9956289 · product · 27 Jan 2026