GIVLAARI
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US10119143 c20; givosiran strands/modifications/L96 compared. US11028392 same date.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10131907 | 2028-08-24 | DS/DP/U U-2672 | Y | N | TRUE_DS | B1C03P8 issued-claim review2026-10-15: TRUE_DS | — | — | — |
| 10131907 | 2028-08-24 | ORANGE_BOOK U-2672 | Y | N | TRUE_DS English description not available. | — | — | — |
| 8828956 | 2028-12-04 | DS/DP/U U-2672 | Y | N | TRUE_DS | B1C03P8 issued-claim review2026-10-15: TRUE_DS | — | — | — |
| 8828956 | 2028-12-04 | ORANGE_BOOK U-2672 | Y | N | TRUE_DS English description not available. | — | — | — |
| 8106022 | 2029-12-12 | DS/DP/U U-2672 | Y | N | TRUE_DS | B1C03P8 issued-claim review2026-10-15: TRUE_DS | — | — | — |
| 8106022 | 2029-12-12 | ORANGE_BOOK U-2672 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10125364 | 2033-03-15 | DS/DP/U U-2672 | Y | N | TRUE_DS | B1C03P8 issued-claim review2026-10-15: TRUE_DS | — | — | — |
| 10125364 | 2033-03-15 | ORANGE_BOOK U-2672 | Y | N | TRUE_DS English description not available. | — | — | — |
| 9631193 | 2033-03-15 | U U-2672 | N | Y | U | B1C03P8 issued-claim review2026-10-15: U | — | — | — |
| 9631193 | 2033-03-15 | ORANGE_BOOK U-2672 | N | Y | U English description not available. | — | — | — |
| 9133461 | 2033-11-20 | DS/DP/U U-2672 | Y | N | TRUE_DS | B1C03P8 issued-claim review2026-10-15: TRUE_DS | — | — | — |
| 9133461 | 2033-11-20 | ORANGE_BOOK U-2672 | Y | N | TRUE_DS English description not available. | — | — | — |
| 10119143 | 2034-10-03 | DS/DP/U U-2672 | Y | N | TRUE_DS | B1C03P8 issued-claim review2026-10-15: TRUE_DS | — | — | — |
| 10119143 | 2034-10-03 | ORANGE_BOOK U-2672 | Y | N | TRUE_DS English description not available. | — | — | — |
| 11028392 | 2034-10-03 | DS/DP/U U-2672 | Y | N | TRUE_DS | B1C03P8 issued-claim review2026-10-15: TRUE_DS | — | — | — |
| 11028392 | 2034-10-03 | ORANGE_BOOK U-2672 | Y | N | TRUE_DS English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2019-11-20 | 2024-11-20 | English description not available. | Y | Y | 2024-11-20 | ODE-273
Full coverage date: 2024-11-20
| Source |
| ODE-273 | 2019-11-20 | 2026-11-20 | English description not available. | Y | Y | 2026-11-20 | — | Source |
| ODE-273 | 2019-11-20 | 2026-11-20 | English description not available. | Y | Y | 2026-11-20 | ODE-273
Full coverage date: 2026-11-20
| Source |
2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · 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 | US10119143 c20; givosiran strands/modifications/L96 compared. US11028392 same date. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2034 | CANDIDATE | FINAL | 2034-10-03 | 2026-10-17 20:32:21 |
| N | 2034 | CANDIDATE | FINAL | 2034-10-03 | 2026-10-15 03:06:32 |
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.