azelaic acid · Leo Pharma As · NDA 021470, 207071
Finacea
Earliest generic entry, as listed · earliest of 2 marketed strengths
28 Feb 2029
1 of 2 marketed strengths has no unexpired patent or exclusivity listed.
Blocked by patent: US 9211259. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9211259 | use U-1796 · sets the listed date | 28 Feb 2029 |
| US 9265725 | drug product | 8 Dec 2027 |
| US 10117812 | drug product, use U-1796 | 18 Oct 2027 |
| US 7700076 | drug product | 18 Sep 2027 |
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
- Generic tentatively approved · ANDA 212581, Taro Pharm Inds Ltd · 207071-001Tentative approval 26 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021470 · 001 · RLD | gel, topical | 15% | open |
| 207071 · 001 · RLD | aerosol, foam, topical | 15% | 28 Feb 2029 |