FDA Orange Book · active-ingredient family
Nusinersen sodium
Nusinersen sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SPINRAZA · NDA 209531
1
Brand (NDA)
0
Generics (ANDA)
7
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SPINRAZARLD×3 | BIOGEN | NDA 209531 | — | Dec 23, 2016 |
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7838657 | Jul 11, 2027 | in 1 yr 1 mo | Substance |
| 9717750 | Jun 17, 2030 | in 4 yr 1 mo | U-1942 |
| 8980853 | Nov 24, 2030 | in 4 yr 6 mo | U-1941 |
| 8361977 | Dec 23, 2030 | in 4 yr 7 mo | SubstanceProduct |
| 9926559 | Jan 09, 2034 | in 7 yr 8 mo | U-1943 |
| 10436802 | Sep 11, 2035 | in 9 yr 4 mo | U-2094 |
| 12013403 | Mar 04, 2036 | in 9 yr 10 mo | U-1941 |
Nusinersen sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
