CAPIVASERTIB | N218197 | ASTRAZENECA PHARMACEUTICALS LP
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8101623 | Mar 10, 2030 | — | Yes | Yes | — | |
| 9487525 | Apr 16, 2033 | — | Yes | Yes | — | — |
| 9492453Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Oct 10, 2028 | — | — | — | — | |
| 10039766Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Apr 16, 2033 | — | — | — | — | |
| 10059714 | Oct 10, 2028 | — | Yes | Yes | — | — |
| 10654855 | Oct 10, 2028 | — | — | — | — | |
| 11236095Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Oct 10, 2028 | — | — | — | — | |
| 11760760 | Oct 10, 2028 | — | — | — | — | |
| 12252495 | Oct 10, 2028 | — | — | — | — |
| Code | Date | Status |
|---|---|---|
| NCE | Nov 16, 2028 | Active |
| I-991Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Jun 12, 2029 | Active |
AstraZeneca added pediatric exclusivity (I-991) to TRUQAP (capivasertib), extending regulatory exclusivity to Jun 2029.
New: TRUQAP (CAPIVASERTIB) — exclusivity I-991 exp 06/12/2029
AstraZeneca gained a new regulatory exclusivity designation (I-991) for TRUQAP (capivasertib) expiring Jun 2029 under NDA 218197, Supplement 002.
New: TRUQAP (CAPIVASERTIB) — exclusivity I-991 exp 06/12/2029