Orange Book product · Brand (NDA)
AMELUZ
AMINOLEVULINIC ACID HYDROCHLORIDE
At a glance
May 10, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 10, 2016
10 yr 3 mo ago
Today
Exclusivity ends · D-194
New indication / change exclusivity (3 years)
Oct 04, 2027
in 1 yr 4 mo
Patent 11540981 expires
Listed drug product patent expiration.
Feb 07, 2028
in 1 yr 8 mo
Patent 11235169 expires
Listed method-of-use patent (U-3303) expiration.
Oct 15, 2040
in 14 yr 6 mo
Patent 12280146 expires
Listed drug product patent expiration.
Dec 08, 2043
in 17 yr 9 mo
Pharmaceutical detail
Active ingredient
AMINOLEVULINIC ACID HYDROCHLORIDE
Strength
10%
Dosage form
GEL
Route
TOPICAL
TE code
Not listed
Application
NDA 208081
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- D-194New indication / change exclusivity (3 years)
Oct 04, 2027
in 1 yr 4 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11540981 | Feb 07, 2028 | in 1 yr 8 mo | Product |
| 11235169 | Oct 15, 2040 | in 14 yr 6 mo | U-3303 |
| 12280146 | Dec 08, 2043 | in 17 yr 9 mo | Product |
