FDA Orange Book · active-ingredient family
Lifitegrast
Lifitegrast is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:XIIDRA · NDA 208073
1
Brand (NDA)
3
Generics (ANDA)
10
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XIIDRARLD | BAUSCH AND LOMB INC | NDA 208073 | — | Jul 11, 2016 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LIFITEGRAST | INGENUS PHARMS LLC | ANDA 215058 | — | Oct 03, 2024 | |
| LIFITEGRAST | EUGIA PHARMA | ANDA 215063 | — | Nov 07, 2023 | |
| LIFITEGRAST | MICRO LABS | ANDA 215081 | — | Aug 04, 2023 |
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8592450 | May 17, 2026 | 1 mo ago | U-1880 |
| 8084047 | May 17, 2026 | 1 mo ago | SubstanceProduct |
| 9447077 | Apr 15, 2029 | in 2 yr 10 mo | U-1900 |
| 8367701 | Apr 15, 2029 | in 2 yr 10 mo | ProductU-1880 |
| 8168655 | May 09, 2029 | in 2 yr 11 mo | U-1880 |
| 9890141 | Oct 21, 2030 | in 4 yr 5 mo | Substance |
| 9353088 | Oct 21, 2030 | in 4 yr 5 mo | Product |
| 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 |
Lifitegrast — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
