aminolevulinic acid hydrochloride · Sun Pharm Inds Inc · NDA 020965
Levulan
Earliest generic entry, as listed
12 Jan 2038
Blocked by patent: US 10357567, US 11077192, US 11135293, US 11571478, US 11690914, US 12296011. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10357567 | use U-3163 | 12 Jan 2038 |
| US 11077192 | use U-3163 | 12 Jan 2038 |
| US 11135293 | use U-3163 | 12 Jan 2038 |
| US 11571478 | use U-3163 | 12 Jan 2038 |
| US 11690914 | use U-3163 | 12 Jan 2038 |
| US 12296011 | use U-3163 | 12 Jan 2038 |
| US 11446512 | use U-804 | 17 Jan 2037 |
| US 11179574 | use U-804 | 13 Oct 2036 |
| US 11697028 | use U-804 | 13 Oct 2036 |
| US 12290700 | use U-804 | 13 Oct 2036 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020965 · 001 · RLD | solution, topical | 20% | 12 Jan 2038 |