FDA Orange Book
Is there a generic for Qfitlia?
Qfitlia contains fitusiran. 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 Qfitlia (fitusiran). The Orange Book shows its last listed patent expires December 7, 2036 and its last listed exclusivity ends March 28, 2032.
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Qfitlia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) | Marketed (Rx) | None | 0 | None |
NDA 219019, held by GENZYME CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Qfitlia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9376680 | March 15, 2033 | Drug substance, Drug product | U-4165 | 219019 |
| 9127274 | March 22, 2033 | Drug substance, Drug product | U-4165 | 219019 |
| RE50996 | March 22, 2033 | Drug substance, Drug product | U-4165 | 219019 |
| 11091759 | December 7, 2036 | Method of use | U-4165 | 219019 |
Qfitlia exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | March 28, 2030 | 219019 |
| ODE-510 | Orphan drug exclusivity | March 28, 2032 | 219019 |
| ODE-511 | Orphan drug exclusivity | March 28, 2032 | 219019 |
Qfitlia NDC codes
Questions
Is there a generic for Qfitlia?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Qfitlia (fitusiran). The Orange Book shows its last listed patent expires December 7, 2036 and its last listed exclusivity ends March 28, 2032.
What is the generic name for Qfitlia?
The active ingredient in Qfitlia is fitusiran, per the FDA Orange Book.
When does the Qfitlia patent expire?
The last patent listed for Qfitlia in the Orange Book expires December 7, 2036. 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.