FDA Orange Book
Is there a generic for Qalsody?
Qalsody contains tofersen. 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 Qalsody (tofersen). The Orange Book shows its last listed patent expires April 1, 2035 and its last listed exclusivity ends April 25, 2030.
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Qalsody products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intrathecal | 100MG/15ML (6.7MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 215887, held by BIOGEN MA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Qalsody patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10968453 | April 1, 2035 | Method of use | U-3575 | 215887 |
| 10669546 | April 1, 2035 | Method of use | U-3575 | 215887 |
| 10385341 | April 1, 2035 | Drug substance, Drug product | None | 215887 |
Qalsody exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | April 25, 2028 | 215887 |
| ODE-432 | Orphan drug exclusivity | April 25, 2030 | 215887 |
Qalsody NDC codes
Questions
Is there a generic for Qalsody?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Qalsody (tofersen). The Orange Book shows its last listed patent expires April 1, 2035 and its last listed exclusivity ends April 25, 2030.
What is the generic name for Qalsody?
The active ingredient in Qalsody is tofersen, per the FDA Orange Book.
When does the Qalsody patent expire?
The last patent listed for Qalsody in the Orange Book expires April 1, 2035. 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.