LUTATHERA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: EXISTING_GENERIC. Reference year: 2026. Anchor type: EXISTING_GENERIC. Patent anchor: not recorded. Exclusivity anchor: 2025-07-26. Anchor date: 2026-09-21. Patent tail: not established. Exclusivity tail: not established. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10596276 | 2038-07-25 | DP — | — | — | — | — | — | — |
| 10596278 | 2038-07-25 | DP — | — | — | — | — | — | — |
| 11904027 | 2038-07-25 | DP — | — | — | — | — | — | — |
| 12144873 | 2038-07-25 | U U-4036 | — | — | — | — | — | — |
| 12151003 | 2038-07-25 | DP/U U-4036 | — | — | — | — | — | — |
| 12161732 | 2038-07-25 | DP/U U-4036 | — | — | — | — | — | — |
| 12168063 | 2038-07-25 | DP/U U-4036 | — | — | — | — | — | — |
| 12415003 | 2038-07-25 | U U-4036 | — | — | — | — | — | — |
| 12491272 | 2038-07-25 | U U-4036 | — | — | — | — | — | — |
| 10596276 | 2039-01-25 | — — | — | — | — | — | 2039-01-25 | — |
| 10596278 | 2039-01-25 | — — | — | — | — | — | 2039-01-25 | — |
| 11904027 | 2039-01-25 | — — | — | — | — | — | 2039-01-25 | — |
| 12144873 | 2039-01-25 | — — | — | — | — | — | 2039-01-25 | — |
| 12151003 | 2039-01-25 | — — | — | — | — | — | 2039-01-25 | — |
| 12161732 | 2039-01-25 | — — | — | — | — | — | 2039-01-25 | — |
| 12168063 | 2039-01-25 | — — | — | — | — | — | 2039-01-25 | — |
| 12415003 | 2039-01-25 | — — | — | — | — | — | 2039-01-25 | — |
| 12491272 | 2039-01-25 | — — | — | — | — | — | 2039-01-25 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NPP | — | 2027-04-23 | — | — | — | — | Source | |
| PED | — | 2027-10-23 | — | — | — | — | Source | |
| ODE-479 | — | 2031-04-23 | — | — | — | — | Source | |
| PED | — | 2031-10-23 | — | — | — | — | 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 |
|---|---|---|---|---|---|---|---|
| 217060 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | LANTHEUS MEDICAL | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 217060 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2026-09-21 | — | LANTHEUS MEDICAL | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
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 1 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 |
|---|---|---|---|---|---|---|
| 217060 / 001 | LANTHEUS MEDICAL | FINAL_APPROVAL · FINAL_APPROVED | 2026-09-21 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
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.