FDA Orange Book
Is there a generic for Pluvicto?
Pluvicto contains lutetium lu-177 vipivotide tetraxetan. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pluvicto (lutetium lu-177 vipivotide tetraxetan). The Orange Book shows its last listed patent expires September 18, 2041 and its last listed exclusivity ends July 31, 2029.
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Pluvicto products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 27mCi/ML | Marketed (Rx) | None | 0 | None |
NDA 215833, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Pluvicto patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11318121 | August 15, 2028 | Drug substance, Drug product | U-4169 | 215833 |
| 10406240 | August 15, 2028 | Drug substance, Drug product | U-4169 | 215833 |
| 11318121 | August 15, 2028 | Drug substance, Drug product | U-4594 | 215833 |
| 11318121 | August 15, 2028 | Drug substance, Drug product | U-4593 | 215833 |
| 10406240 | August 15, 2028 | Drug substance, Drug product | U-4594 | 215833 |
| 10406240 | August 15, 2028 | Drug substance, Drug product | U-4593 | 215833 |
| 11951190 | November 12, 2035 | Method of use | U-4169 | 215833 |
| 11951190 | November 12, 2035 | Method of use | U-4594 | 215833 |
| 11951190 | November 12, 2035 | Method of use | U-4593 | 215833 |
| 10398791 | March 23, 2036 | Drug substance, Drug product | None | 215833 |
| 12208102 | September 18, 2041 | Method of use | U-4169 | 215833 |
| 12208102 | September 18, 2041 | Method of use | U-4592 | 215833 |
| 12208102 | September 18, 2041 | Method of use | U-4593 | 215833 |
Pluvicto exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | March 23, 2027 | 215833 |
| I-965 | New indication | March 28, 2028 | 215833 |
| I-996 | New indication | July 31, 2029 | 215833 |
Pluvicto NDC codes
Questions
Is there a generic for Pluvicto?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pluvicto (lutetium lu-177 vipivotide tetraxetan). The Orange Book shows its last listed patent expires September 18, 2041 and its last listed exclusivity ends July 31, 2029.
What is the generic name for Pluvicto?
The active ingredient in Pluvicto is lutetium lu-177 vipivotide tetraxetan, per the FDA Orange Book.
When does the Pluvicto patent expire?
The last patent listed for Pluvicto in the Orange Book expires September 18, 2041. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.