FDA Orange Book
Is there a generic for Posluma?
Posluma contains flotufolastat f-18 gallium. 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 Posluma (flotufolastat f-18 gallium). The Orange Book shows its last listed patent expires November 27, 2041 and its last listed exclusivity ends May 25, 2028.
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Posluma products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 25ML (8-158mCi/ML) | Marketed (Rx) | None | 0 | None |
NDA 216023, held by BLUE EARTH DIAGNOSTICS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Posluma patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12390540 | August 23, 2038 | Drug substance | None | 216023 |
| 11413360 | November 22, 2038 | Drug substance | U-3614 | 216023 |
| 11413360 | November 22, 2038 | Drug substance | U-3615 | 216023 |
| 12357711 | November 22, 2038 | Drug substance | None | 216023 |
| 12377176 | November 22, 2038 | Drug substance | None | 216023 |
| 12036290 | November 27, 2041 | Drug product | U-3614 | 216023 |
| 12036290 | November 27, 2041 | Drug product | U-3615 | 216023 |
| 12427207 | November 27, 2041 | Drug product | None | 216023 |
Posluma exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 25, 2028 | 216023 |
Posluma NDC codes
Questions
Is there a generic for Posluma?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Posluma (flotufolastat f-18 gallium). The Orange Book shows its last listed patent expires November 27, 2041 and its last listed exclusivity ends May 25, 2028.
What is the generic name for Posluma?
The active ingredient in Posluma is flotufolastat f-18 gallium, per the FDA Orange Book.
When does the Posluma patent expire?
The last patent listed for Posluma in the Orange Book expires November 27, 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.