imiquimod · Bausch · NDA 022483
Zyclara
Earliest generic entry, as listed · earliest of 2 marketed strengths
11 Dec 2029
Other strengths are listed to 30 Apr 2030.
Blocked by patent: US 10238644, US 11318130, US 8222270, US 8236816, US 8299109. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 15 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10918635 | use U-1455 | 30 Apr 2030 |
| US 10918635 | use U-172 | 30 Apr 2030 |
| US 11202752 | use U-1455 | 30 Apr 2030 |
| US 11202752 | use U-172 | 30 Apr 2030 |
| US 11850245 | use U-172 | 30 Apr 2030 |
| US 11850245 | use U-1455 | 30 Apr 2030 |
| US 10238644 | use U-68 | 11 Dec 2029 |
| US 11318130 | use U-68 | 11 Dec 2029 |
| US 8222270 | use U-68 | 11 Dec 2029 |
| US 8236816 | use U-68 | 11 Dec 2029 |
| US 8299109 | use U-68 | 11 Dec 2029 |
| US 10238645 | use U-1455 | 18 Aug 2029 |
| US 10238645 | use U-172 | 18 Aug 2029 |
| US 8598196 | use U-172 | 18 Aug 2029 |
| US 8598196 | use U-1455 | 18 Aug 2029 |
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022483 · 001 · RLD | cream, topical | 3.75% | 30 Apr 2030 |
| 022483 · 002 · RLD | cream, topical | 2.5% | 11 Dec 2029 |