LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN | N215833 | NOVARTIS PHARMACEUTICALS CORP
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 10398791 | Mar 23, 2036 | — | Yes | Yes | — | — |
| 10406240Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Aug 15, 2028 | — | Yes | Yes | — | |
| 11318121Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Aug 15, 2028 | — | Yes | Yes | — | |
| 11951190Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Nov 12, 2035 | — | — | — | — | |
| 12208102Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Sep 18, 2041 | — | — | — | — |
| Code | Date | Status |
|---|---|---|
| I-965 | Mar 28, 2028 | Active |
| NCE | Mar 23, 2027 | < 1 year |
| I-996Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Jul 31, 2029 | Active |
Novartis gained orphan drug exclusivity (expiring Jul 2029) for PLUVICTO (lutetium Lu-177 vipivotide tetraxetan) in NDA 215833.
New: PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — exclusivity I-996 exp 07/31/2029