Drug profile
Nusinersen
GenericRadar assessment
Patent Radar Assessment
Grade A2
United States · 2030 Radar
Verification
HIGH
Why Grade A?
FDA June 2026 Orange Book cumulative supplement lists US8361977 as Drug Substance/Drug Product for SPINRAZA expiring 2030-12-23.
Core Patent Expiry
2030-12-23
2030 Target Event
US8361977
Drug Substance / Drug Product · 2030-12-23
Core API Event?
Yes
Later Blocking Patents
Yes. SPINRAZA has method/use patents in 2030 and other patents extending beyond 2030, including 2034-2035.
Generic Entry Assessment
Strong 2030 DS/DP radar event. Because nusinersen is an antisense oligonucleotide, manufacturing/regulatory sourcing should be treated separately from conventional small-molecule API sourcing.
Patent landscape
| Country | Patent no. | Type | Expiry | Status | Verified | Opportunity |
|---|---|---|---|---|---|---|
| United States | US8361977 | Drug Substance / Drug Product | 2030-12-23 | Protected | Yes | 63 |
API sourcing
Regulatory filing labels distinguish verified/listed records from records that have not yet been verified. “Not verified” does not mean that a filing does not exist.
| API | Manufacturer | Country | US DMF | KDMF | Japan MF | CEP | EU GMP | Status |
|---|---|---|---|---|---|---|---|---|
| Nusinersen sodium | Aurisco Pharmaceutical | China | ✓ Listed | Not verified | Not verified | Not verified | Not verified | US DMF listed |
| Nusinersen sodium | Chongqing Carelife Pharmaceutical | China | ✓ Listed | Not verified | Not verified | Not verified | Not verified | US DMF listed |
| Nusinersen sodium | Ionis Pharmaceuticals | United States | Not verified | Not verified | Not verified | Not verified | Not verified | Innovator / bulk API source |
| Nusinersen sodium | Shandong Anxin Pharmaceutical | China | ✓ Listed | Not verified | Not verified | Not verified | Not verified | US DMF listed |
| Nusinersen sodium | Shanghai Sine Pharmaceutical Laboratories Co.,Ltd. | China | ✓ Listed | Not verified | Not verified | Not verified | Not verified | US DMF listed |
| Nusinersen sodium | Sichuan Gowell Pharmaceutical | China | ✓ Listed | Not verified | Not verified | Not verified | Not verified | US DMF listed |