Orange Book product · Brand (NDA)
XDEMVY
LOTILANER
At a glance
Jul 24, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 24, 2023
2 yr 11 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jul 24, 2028
in 2 yr 2 mo
Patent 8383659 expires
Listed drug substance patent expiration.
Jan 17, 2030
in 3 yr 8 mo
Patent 10835517 expires
Listed method-of-use patent (U-3674) expiration.
Dec 14, 2038
in 12 yr 8 mo
Patent 11197847 expires
Listed method-of-use patent (U-3674) expiration.
Dec 14, 2038
in 12 yr 8 mo
Patent 11690826 expires
Listed method-of-use patent (U-3674) expiration.
Dec 14, 2038
in 12 yr 8 mo
Patent 11690827 expires
Listed method-of-use patent (U-3674) expiration.
Dec 14, 2038
in 12 yr 8 mo
Patent 11752137 expires
Listed drug product patent expiration.
Dec 14, 2038
in 12 yr 8 mo
Patent 12171750 expires
Listed method-of-use patent (U-3674) expiration.
Dec 14, 2038
in 12 yr 8 mo
Patent 12213964 expires
Listed drug product patent expiration.
Dec 14, 2038
in 12 yr 8 mo
Patent 12364685 expires
Listed drug product patent expiration.
Dec 14, 2038
in 12 yr 8 mo
Pharmaceutical detail
Active ingredient
LOTILANER
Strength
0.25%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 217603
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)
- NCENew chemical entity exclusivity (5 years)
Jul 24, 2028
in 2 yr 2 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8383659 | Jan 17, 2030 | in 3 yr 8 mo | SubstanceProduct |
| 10835517 | Dec 14, 2038 | in 12 yr 8 mo | U-3674 |
| 11197847 | Dec 14, 2038 | in 12 yr 8 mo | U-3674 |
| 11690826 | Dec 14, 2038 | in 12 yr 8 mo | U-3674 |
| 11690827 | Dec 14, 2038 | in 12 yr 8 mo | U-3674 |
| 11752137 | Dec 14, 2038 | in 12 yr 8 mo | Product |
| 12171750 | Dec 14, 2038 | in 12 yr 8 mo | U-3674 |
| 12213964 | Dec 14, 2038 | in 12 yr 8 mo | Product |
| 12364685 | Dec 14, 2038 | in 12 yr 8 mo | Product |

