FDA Orange Book
Is there a generic for Spinraza?
Spinraza contains nusinersen. 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 Spinraza (nusinersen). The Orange Book shows its last listed patent expires March 4, 2036 and its last listed exclusivity ends March 27, 2029.
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Spinraza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intrathecal | EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| solution, intrathecal | EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| solution, intrathecal | EQ 50MG BASE/5ML (EQ 10MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 209531, held by BIOGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Spinraza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7838657 | July 11, 2027 | Drug substance | None | 209531 |
| 9717750 | June 17, 2030 | Method of use | U-1942 | 209531 |
| 9717750 | June 17, 2030 | Method of use | U-2094 | 209531 |
| 9717750 | June 17, 2030 | Method of use | U-2093 | 209531 |
| 9717750 | June 17, 2030 | Method of use | U-1943 | 209531 |
| 8980853 | November 24, 2030 | Method of use | U-1941 | 209531 |
| 8361977 | December 23, 2030 | Drug substance, Drug product | None | 209531 |
| 9926559 | January 9, 2034 | Method of use | U-1943 | 209531 |
| 10436802 | September 11, 2035 | Method of use | U-2094 | 209531 |
| 10436802 | September 11, 2035 | Method of use | U-1943 | 209531 |
| 10436802 | September 11, 2035 | Method of use | U-1941 | 209531 |
| 10436802 | September 11, 2035 | Method of use | U-2093 | 209531 |
| 10436802 | September 11, 2035 | Method of use | U-1944 | 209531 |
| 10436802 | September 11, 2035 | Method of use | U-1942 | 209531 |
| 12013403 | March 4, 2036 | Method of use | U-1941 | 209531 |
| 12013403 | March 4, 2036 | Method of use | U-1942 | 209531 |
| 12013403 | March 4, 2036 | Method of use | U-1943 | 209531 |
| 12013403 | March 4, 2036 | Method of use | U-1944 | 209531 |
| 12013403 | March 4, 2036 | Method of use | U-2093 | 209531 |
| 12013403 | March 4, 2036 | Method of use | U-2094 | 209531 |
Spinraza exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NS | New strength | March 27, 2029 | 209531 |
Spinraza NDC codes
Questions
Is there a generic for Spinraza?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Spinraza (nusinersen). The Orange Book shows its last listed patent expires March 4, 2036 and its last listed exclusivity ends March 27, 2029.
What is the generic name for Spinraza?
The active ingredient in Spinraza is nusinersen, per the FDA Orange Book.
When does the Spinraza patent expire?
The last patent listed for Spinraza in the Orange Book expires March 4, 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.