nusinersen sodium · Biogen · NDA 209531
Spinraza
Earliest generic entry, as listed · earliest of 3 marketed strengths
23 Dec 2030
Other strengths are listed to 4 Mar 2036.
Blocked by patent: US 8361977.
Listed patents · 20 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12013403 | use U-2094 | 4 Mar 2036 |
| US 12013403 | use U-1941 | 4 Mar 2036 |
| US 12013403 | use U-1942 | 4 Mar 2036 |
| US 12013403 | use U-1943 | 4 Mar 2036 |
| US 12013403 | use U-1944 | 4 Mar 2036 |
| US 12013403 | use U-2093 | 4 Mar 2036 |
| US 10436802 | use U-2093 | 11 Sep 2035 |
| US 10436802 | use U-1944 | 11 Sep 2035 |
| US 10436802 | use U-1942 | 11 Sep 2035 |
| US 10436802 | use U-2094 | 11 Sep 2035 |
| US 10436802 | use U-1943 | 11 Sep 2035 |
| US 10436802 | use U-1941 | 11 Sep 2035 |
| US 9926559 | use U-1943 | 9 Jan 2034 |
| US 8361977 | substance, product | 23 Dec 2030 |
| US 8980853 | use U-1941 | 24 Nov 2030 |
| US 9717750 | use U-2093 | 17 Jun 2030 |
| US 9717750 | use U-2094 | 17 Jun 2030 |
| US 9717750 | use U-1942 | 17 Jun 2030 |
| US 9717750 | use U-1943 | 17 Jun 2030 |
| US 7838657 | substance, product | 11 Jul 2027 |
Exclusivities · 1 unexpired
| NS | new strength | 27 Mar 2029 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209531 · 001 · RLD | solution, intrathecal | EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML) | 4 Mar 2036 |
| 209531 · 002 · RLD | solution, intrathecal | EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML) | 23 Dec 2030 |
| 209531 · 003 · RLD | solution, intrathecal | EQ 50MG BASE/5ML (EQ 10MG BASE/ML) | 23 Dec 2030 |