Orange Book product · Brand (NDA)
XIIDRA
LIFITEGRAST
At a glance
Jul 11, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 11, 2016
10 yr 1 mo ago
Patent 8084047 expires
Listed drug substance patent expiration.
May 17, 2026
1 mo ago
Patent 8592450 expires
Listed method-of-use patent (U-1880) expiration.
May 17, 2026
1 mo ago
Today
Patent 8367701 expires
Listed drug product patent expiration.
Apr 15, 2029
in 2 yr 10 mo
Patent 9447077 expires
Listed method-of-use patent (U-1900) expiration.
Apr 15, 2029
in 2 yr 10 mo
Patent 8168655 expires
Listed method-of-use patent (U-1880) expiration.
May 09, 2029
in 2 yr 11 mo
Patent 9353088 expires
Listed drug product patent expiration.
Oct 21, 2030
in 4 yr 5 mo
Patent 9890141 expires
Listed drug substance patent expiration.
Oct 21, 2030
in 4 yr 5 mo
Patent 8927574 expires
Listed drug product patent expiration.
Nov 12, 2030
in 4 yr 6 mo
Patent 9085553 expires
Listed drug product patent expiration.
Jul 25, 2033
in 7 yr 2 mo
Patent 11058677 expires
Listed drug product patent expiration.
Dec 18, 2033
in 7 yr 7 mo
Pharmaceutical detail
Active ingredient
LIFITEGRAST
Strength
5%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 208073
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 |
|---|---|---|---|
| 8084047 | May 17, 2026 | 1 mo ago | SubstanceProduct |
| 8592450 | May 17, 2026 | 1 mo ago | U-1880 |
| 8367701 | Apr 15, 2029 | in 2 yr 10 mo | ProductU-1880 |
| 9447077 | Apr 15, 2029 | in 2 yr 10 mo | U-1900 |
| 8168655 | May 09, 2029 | in 2 yr 11 mo | U-1880 |
| 9353088 | Oct 21, 2030 | in 4 yr 5 mo | Product |
| 9890141 | Oct 21, 2030 | in 4 yr 5 mo | Substance |
| 8927574 | Nov 12, 2030 | in 4 yr 6 mo | Product |
| 9085553 | Jul 25, 2033 | in 7 yr 2 mo | Product |
| 11058677 | Dec 18, 2033 | in 7 yr 7 mo | Product |
