aminolevulinic acid hydrochloride · Biofrontera · NDA 208081
Ameluz
Earliest generic entry, as listed
8 Dec 2043
Blocked by patent: US 12280146.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12280146 | drug product · sets the listed date | 8 Dec 2043 |
| US 11235169 | use U-3303 | 15 Oct 2040 |
| US 11540981 | drug product | 7 Feb 2028 |
Exclusivities · 1 unexpired
| D-194 | new dosing schedule | 4 Oct 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 |
|---|---|---|---|
| 208081 · 001 · RLD | gel, topical | 10% | 8 Dec 2043 |