lutetium lu-177 vipivotide tetraxetan · Novartis · NDA 215833
Pluvicto
Orange Book file dated 13 Oct 2026 · ingested 26 Oct 2026 · run #7
Blocked by patent: US 12208102. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
How this date was calculated
- Each strength's date is the later of its latest unexpired, non-delisted patent and its latest unexpired exclusivity, as listed in the Orange Book. A pediatric extension is already in the date FDA lists on the *PED row, so nothing is added again.
- The date shown is that of the one marketed reference-listed strength.
- 18 Sep 2041 is the expiry FDA lists for US 12208102 (basis: patent).
- Counted: 5 unexpired patents and 3 unexpired exclusivity codes.
- Carve-out possible: every unexpired patent listed to this date claims only a method of use, so a generic may seek approval without that use (section viii).
- FDA records these listings as submitted and does not verify them. Litigation, settlements, 30-month stays and at-risk launches are not in the Orange Book.
Listed patents · 5 unexpired
13 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12208102 · FDA | use U-4169, U-4592, U-4593 | 18 Sep 2041 |
| US 12208102 listing row | use U-4169 · sets the listed date | 18 Sep 2041 |
| US 12208102 listing row | use U-4592 · sets the listed date | 18 Sep 2041 |
| US 12208102 listing row | use U-4593 · sets the listed date | 18 Sep 2041 |
| US 10398791 · FDA | drug substance, drug product | 23 Mar 2036 |
| US 11951190 · FDA | use U-4169, U-4593, U-4594 | 12 Nov 2035 |
| US 11951190 listing row | use U-4169 | 12 Nov 2035 |
| US 11951190 listing row | use U-4593 | 12 Nov 2035 |
| US 11951190 listing row | use U-4594 | 12 Nov 2035 |
| US 10406240 · FDA | drug substance, drug product, use U-4169, U-4593, U-4594 | 15 Aug 2028 |
| US 10406240 listing row | drug substance, drug product, use U-4169 | 15 Aug 2028 |
| US 10406240 listing row | drug substance, drug product, use U-4593 | 15 Aug 2028 |
| US 10406240 listing row | drug substance, drug product, use U-4594 | 15 Aug 2028 |
| US 11318121 · FDA | drug substance, drug product, use U-4169, U-4593, U-4594 | 15 Aug 2028 |
| US 11318121 listing row | drug substance, drug product, use U-4169 | 15 Aug 2028 |
| US 11318121 listing row | drug substance, drug product, use U-4593 | 15 Aug 2028 |
| US 11318121 listing row | drug substance, drug product, use U-4594 | 15 Aug 2028 |
Exclusivities · 3 unexpired
| I-996 | new indication (3 years) | 31 Jul 2029 |
| I-965 | new indication (3 years) | 28 Mar 2028 |
| NCE | new chemical entity (5 years) | 23 Mar 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed protection ends |
|---|---|---|---|
| 215833 · 001 · RLD | solution, intravenous | 27mCi/ML | 18 Sep 2041 |
Each NDA · product number links to its FDA Orange Book patent and exclusivity listing.