clotrimazole · Carwin Pharm Assoc · NDA 217628
Clotic
Earliest generic entry, as listed
26 May 2042
Blocked by patent: US 12246006.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12246006 | drug product, use U-4276 · sets the listed date | 26 May 2042 |
Exclusivities · 3 unexpired
| GAIN | qualified infectious disease product | 26 Sep 2037 |
| GAIN | qualified infectious disease product | 26 Sep 2033 |
| ODE-549 | orphan drug (7 years) | 26 Sep 2032 |
| NP | new product | 26 Sep 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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 217628 · 001 · RLD | solution/drops, otic | 1% | 26 May 2042 |