Orange Book product · Brand (NDA)
LEVULAN
AMINOLEVULINIC ACID HYDROCHLORIDE
At a glance
Dec 03, 1999
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 03, 1999
26 yr 11 mo ago
Today
Patent 11179574 expires
Listed method-of-use patent (U-804) expiration.
Oct 13, 2036
in 10 yr 6 mo
Patent 11697028 expires
Listed method-of-use patent (U-804) expiration.
Oct 13, 2036
in 10 yr 6 mo
Patent 12290700 expires
Listed method-of-use patent (U-804) expiration.
Oct 13, 2036
in 10 yr 6 mo
Patent 11446512 expires
Listed method-of-use patent (U-804) expiration.
Jan 17, 2037
in 10 yr 9 mo
Patent 10357567 expires
Listed method-of-use patent (U-3163) expiration.
Jan 12, 2038
in 11 yr 9 mo
Patent 11077192 expires
Listed method-of-use patent (U-3163) expiration.
Jan 12, 2038
in 11 yr 9 mo
Patent 11135293 expires
Listed method-of-use patent (U-3163) expiration.
Jan 12, 2038
in 11 yr 9 mo
Patent 11571478 expires
Listed method-of-use patent (U-3163) expiration.
Jan 12, 2038
in 11 yr 9 mo
Patent 11690914 expires
Listed method-of-use patent (U-3163) expiration.
Jan 12, 2038
in 11 yr 9 mo
Patent 12296011 expires
Listed method-of-use patent (U-3163) expiration.
Jan 12, 2038
in 11 yr 9 mo
Pharmaceutical detail
Active ingredient
AMINOLEVULINIC ACID HYDROCHLORIDE
Strength
20%
Dosage form
SOLUTION
Route
TOPICAL
TE code
Not listed
Application
NDA 020965
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.
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11179574 | Oct 13, 2036 | in 10 yr 6 mo | U-804 |
| 11697028 | Oct 13, 2036 | in 10 yr 6 mo | U-804 |
| 12290700 | Oct 13, 2036 | in 10 yr 6 mo | U-804 |
| 11446512 | Jan 17, 2037 | in 10 yr 9 mo | U-804 |
| 10357567 | Jan 12, 2038 | in 11 yr 9 mo | U-3163 |
| 11077192 | Jan 12, 2038 | in 11 yr 9 mo | U-3163 |
| 11135293 | Jan 12, 2038 | in 11 yr 9 mo | U-3163 |
| 11571478 | Jan 12, 2038 | in 11 yr 9 mo | U-3163 |
| 11690914 | Jan 12, 2038 | in 11 yr 9 mo | U-3163 |
| 12296011 | Jan 12, 2038 | in 11 yr 9 mo | U-3163 |
