FDA Orange Book
Is there a generic for Signifor?
Signifor contains pasireotide diaspartate. 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 (pasireotide diaspartate). The Orange Book shows its last listed patent expires December 14, 2026.
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Signifor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 200677, 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 patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7473761 | December 14, 2026 | Drug substance, Drug product | None | 200677 |
Signifor NDC codes
Questions
Is there a generic for Signifor?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Signifor (pasireotide diaspartate). The Orange Book shows its last listed patent expires December 14, 2026.
What is the generic name for Signifor?
The active ingredient in Signifor is pasireotide diaspartate, per the FDA Orange Book.
When does the Signifor patent expire?
The last patent listed for Signifor in the Orange Book expires December 14, 2026. 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.