tirbanibulin · Almirall · NDA 213189
Klisyri
Earliest generic entry, as listed
7 Sep 2038
Blocked by patent: US 10669236.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10669236 | drug substance, drug product · sets the listed date | 7 Sep 2038 |
| US 10617693 | use U-3015 | 12 Mar 2038 |
| US 11497750 | use U-3015 | 12 Mar 2038 |
| US 12667576 | use U-4577 | 12 Mar 2038 |
| US 7300931 | drug substance, drug product | 28 Dec 2030 |
| US 7851470 | drug substance, drug product, use U-3015 | 2 Feb 2029 |
| US 10323001 | drug product | 28 Dec 2027 |
Exclusivities · 1 unexpired
| D-192 | new dosing schedule | 7 Jun 2027 |
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 |
|---|---|---|---|
| 213189 · 001 · RLD | ointment, topical | 1% | 7 Sep 2038 |