SPINRAZA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US10436802 c1 anchor2035-09-11. US12013403 independent c3 does not require fourth60-70day dose; approximately15/29/183/302days whole-label scope not established. No DS promotion;2036-03-04 tail retained.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7838657 | 2027-07-11 | DS — | Y | N | TRUE_DS | — | — | — |
| 9717750 | 2030-06-17 | U U-1943 | N | Y | DS_EQUIVALENT | — | — | — |
| 9717750 | 2030-06-17 | U U-1942 | N | Y | DS_EQUIVALENT | — | — | — |
| 9717750 | 2030-06-17 | U U-2094 | N | Y | DS_EQUIVALENT | — | — | — |
| 9717750 | 2030-06-17 | U U-2093 | N | Y | DS_EQUIVALENT | — | — | — |
| 8980853 | 2030-11-24 | U U-1941 | N | N | U | — | — | — |
| 8361977 | 2030-12-23 | DS/DP — | Y | N | TRUE_DS | — | — | — |
| 9926559 | 2034-01-09 | U U-1943 | N | Y | DS_EQUIVALENT | — | — | — |
| 10436802 | 2035-09-11 | U U-1941 | N | N | U | — | — | — |
| 10436802 | 2035-09-11 | U U-1943 | N | N | U | — | — | — |
| 10436802 | 2035-09-11 | U U-2093 | N | N | U | — | — | — |
| 10436802 | 2035-09-11 | U U-2094 | N | N | U | — | — | — |
| 10436802 | 2035-09-11 | U U-1944 | N | N | U | — | — | — |
| 10436802 | 2035-09-11 | U U-1942 | N | N | U | — | — | — |
| 12013403 | 2036-03-04 | U U-2094 | N | N | U | — | — | — |
| 12013403 | 2036-03-04 | U U-1943 | N | N | U | — | — | — |
| 12013403 | 2036-03-04 | U U-1944 | N | N | U | — | — | — |
| 12013403 | 2036-03-04 | U U-2093 | N | N | U | — | — | — |
| 12013403 | 2036-03-04 | U U-1942 | N | N | U | — | — | — |
| 12013403 | 2036-03-04 | U U-1941 | N | N | U | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| No generic approval facts are linked to this product. | |||||||
Market Entry Information
API filings, authorized generics and linked regulatory milestones.
API Master Files & Certifications 0 records
Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.
| API | Holder / manufacturer | Holder country | Filing type | Number | Status | Filed date | Available for reference | Source | Last verified |
|---|---|---|---|---|---|---|---|---|---|
| No master-file or certification records are linked through public manufacturer portfolios. | |||||||||
Authorized Generics 0 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No authorized-generic records are linked to this product. | ||||||
Tentative ANDA Approvals 0 records
Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.
| Application / product | Applicant | Event / status | Tentative date | Follow-up final approval | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|---|
| No tentative-approval records are linked to this product. | |||||||
Paragraph IV Challenges 0 records
Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.
| Application / product | Applicant | Event / status | Certification event date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No structured Paragraph IV certification events are linked in the available approval evidence. | ||||||
Final ANDA Approvals 0 records
Approval dates do not establish commercial launch. Product mapping is shown for each linked record.
| Application / product | Applicant | Event / status | Final approval date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No final-approval records are linked to this product. | ||||||
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| ANNUAL_DECISION_RECHECK | — | ANCHOR_AND_TAIL | US10436802 c1 anchor2035-09-11. US12013403 independent c3 does not require fourth60-70day dose; approximately15/29/183/302days whole-label scope not established. No DS promotion;2036-03-04 tail retained. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2035 | DEEP_REVIEW | FINAL | 2035-09-11 | 2026-10-17 20:32:21 |
| N | 2034 | DEEP_REVIEW | FINAL | 2034-01-09 | 2026-10-15 19:53:50 |
Litigation & Settlement History
Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.
No litigation or settlement record currently linked to this product.