FDA Orange Book · active-ingredient family
Idelalisib
Idelalisib is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZYDELIG · NDA 205858
1
Brand (NDA)
1
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZYDELIGRLD×2 | GILEAD SCIENCES INC | NDA 205858 | AB | Jul 23, 2014 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IDELALISIB×2 | NATCO | ANDA 216921 | AB | Feb 17, 2026 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9492449 | Mar 11, 2030 | in 3 yr 9 mo | U-1914 |
| 8865730 | Mar 05, 2033 | in 6 yr 10 mo | SubstanceProductU-1615 |
| 10730879 | Mar 05, 2033 | in 6 yr 10 mo | SubstanceProduct |
| 9469643 | Sep 02, 2033 | in 7 yr 4 mo | Substance |
Idelalisib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
