FDA Orange Book
Is there a generic for Signifor Lar Kit?
Signifor Lar Kit contains pasireotide. 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 Signifor Lar Kit (pasireotide). The Orange Book shows its last listed patent expires May 23, 2028.
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Signifor Lar Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, intramuscular | EQ 10MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
| for suspension, intramuscular | EQ 20MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
| for suspension, intramuscular | EQ 30MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
| for suspension, intramuscular | EQ 40MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
| for suspension, intramuscular | EQ 60MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 203255, held by RECORDATI RARE DISEASES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Signifor Lar Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7759308 | October 25, 2026 | Drug product | None | 203255 |
| 7473761 | December 14, 2026 | Drug substance, Drug product | None | 203255 |
| 9351923 | May 23, 2028 | Drug product | None | 203255 |
Questions
Is there a generic for Signifor Lar Kit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Signifor Lar Kit (pasireotide). The Orange Book shows its last listed patent expires May 23, 2028.
What is the generic name for Signifor Lar Kit?
The active ingredient in Signifor Lar Kit is pasireotide, per the FDA Orange Book.
When does the Signifor Lar Kit patent expire?
The last patent listed for Signifor Lar Kit in the Orange Book expires May 23, 2028. 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.