Orange Book product · Brand (NDA)
SPINRAZA
NUSINERSEN SODIUM
At a glance
Dec 23, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
20
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 2016
9 yr 8 mo ago
Today
Patent 7838657 expires
Listed drug substance patent expiration.
Jul 11, 2027
in 1 yr 1 mo
Patent 9717750 expires
Listed method-of-use patent (U-1942) expiration.
Jun 17, 2030
in 4 yr 1 mo
Patent 9717750 expires
Listed method-of-use patent (U-2094) expiration.
Jun 17, 2030
in 4 yr 1 mo
Patent 9717750 expires
Listed method-of-use patent (U-2093) expiration.
Jun 17, 2030
in 4 yr 1 mo
Patent 9717750 expires
Listed method-of-use patent (U-1943) expiration.
Jun 17, 2030
in 4 yr 1 mo
Patent 8980853 expires
Listed method-of-use patent (U-1941) expiration.
Nov 24, 2030
in 4 yr 6 mo
Patent 8361977 expires
Listed drug substance patent expiration.
Dec 23, 2030
in 4 yr 7 mo
Patent 9926559 expires
Listed method-of-use patent (U-1943) expiration.
Jan 09, 2034
in 7 yr 8 mo
Patent 10436802 expires
Listed method-of-use patent (U-2094) expiration.
Sep 11, 2035
in 9 yr 4 mo
Patent 10436802 expires
Listed method-of-use patent (U-1943) expiration.
Sep 11, 2035
in 9 yr 4 mo
Patent 10436802 expires
Listed method-of-use patent (U-1941) expiration.
Sep 11, 2035
in 9 yr 4 mo
Patent 10436802 expires
Listed method-of-use patent (U-2093) expiration.
Sep 11, 2035
in 9 yr 4 mo
Patent 10436802 expires
Listed method-of-use patent (U-1944) expiration.
Sep 11, 2035
in 9 yr 4 mo
Patent 10436802 expires
Listed method-of-use patent (U-1942) expiration.
Sep 11, 2035
in 9 yr 4 mo
Patent 12013403 expires
Listed method-of-use patent (U-1941) expiration.
Mar 04, 2036
in 9 yr 10 mo
Patent 12013403 expires
Listed method-of-use patent (U-1942) expiration.
Mar 04, 2036
in 9 yr 10 mo
Patent 12013403 expires
Listed method-of-use patent (U-1943) expiration.
Mar 04, 2036
in 9 yr 10 mo
Patent 12013403 expires
Listed method-of-use patent (U-1944) expiration.
Mar 04, 2036
in 9 yr 10 mo
Patent 12013403 expires
Listed method-of-use patent (U-2093) expiration.
Mar 04, 2036
in 9 yr 10 mo
Patent 12013403 expires
Listed method-of-use patent (U-2094) expiration.
Mar 04, 2036
in 9 yr 10 mo
Pharmaceutical detail
Active ingredient
NUSINERSEN SODIUM
Strength
EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)
Dosage form
SOLUTION
Route
INTRATHECAL
TE code
Not listed
Application
NDA 209531
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (20)
| 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 |
| 9717750 | Jun 17, 2030 | in 4 yr 1 mo | U-2094 |
| 9717750 | Jun 17, 2030 | in 4 yr 1 mo | U-2093 |
| 9717750 | Jun 17, 2030 | in 4 yr 1 mo | U-1943 |
| 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 |
| 10436802 | Sep 11, 2035 | in 9 yr 4 mo | U-1943 |
| 10436802 | Sep 11, 2035 | in 9 yr 4 mo | U-1941 |
| 10436802 | Sep 11, 2035 | in 9 yr 4 mo | U-2093 |
| 10436802 | Sep 11, 2035 | in 9 yr 4 mo | U-1944 |
| 10436802 | Sep 11, 2035 | in 9 yr 4 mo | U-1942 |
| 12013403 | Mar 04, 2036 | in 9 yr 10 mo | U-1941 |
| 12013403 | Mar 04, 2036 | in 9 yr 10 mo | U-1942 |
| 12013403 | Mar 04, 2036 | in 9 yr 10 mo | U-1943 |
| 12013403 | Mar 04, 2036 | in 9 yr 10 mo | U-1944 |
| 12013403 | Mar 04, 2036 | in 9 yr 10 mo | U-2093 |
| 12013403 | Mar 04, 2036 | in 9 yr 10 mo | U-2094 |
