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· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2033. Anchor type: DS_EQUIVALENT. Patent anchor: 2033-01-11. Exclusivity anchor: 2028-01-21. Anchor date: 2033-01-11. Patent tail: yes. Exclusivity tail: no. Review status: FINAL_CHECKING. 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 |
|---|---|---|---|---|---|---|---|---|
| 10195168 | 2033-01-11 | DP — | — | — | — | — | — | — |
| 10675258 | 2033-01-11 | U U-2938 | — | — | — | — | — | — |
| 11554102 | 2033-01-11 | DP — | — | — | — | — | — | — |
| 8591922 | 2033-01-11 | DP — | — | — | — | — | — | — |
| 8901173 | 2033-01-11 | DP — | — | — | — | — | — | — |
| 9132107 | 2033-01-11 | DP — | — | — | — | — | — | — |
| 10213400 | 2033-03-15 | U U-2499 | — | — | — | — | — | — |
| 10864181 | 2033-03-15 | U U-3017 | — | — | — | — | — | — |
| 11253494 | 2033-03-15 | U U-3324 | — | — | — | — | — | — |
| 11253494 | 2033-03-15 | U U-3323 | — | — | — | — | — | — |
| 11986446 | 2033-03-15 | U U-3017 | — | — | — | — | — | — |
| 11986446 | 2033-03-15 | U U-3324 | — | — | — | — | — | — |
| 8772306 | 2033-03-15 | U U-1532 | — | — | — | — | — | — |
| 8772306 | 2033-03-15 | U U-3198 | — | — | — | — | — | — |
| 9050302 | 2033-03-15 | U U-1532 | — | — | — | — | — | — |
| 9486426 | 2033-03-15 | U U-1532 | — | — | — | — | — | — |
| 10213400 | 2033-09-15 | — — | — | — | — | — | 2033-09-15 | — |
| 10864181 | 2033-09-15 | — — | — | — | — | — | 2033-09-15 | — |
| 11253494 | 2033-09-15 | — — | — | — | — | — | 2033-09-15 | — |
| 8772306 | 2033-09-15 | — — | — | — | — | — | 2033-09-15 | — |
| 9050302 | 2033-09-15 | — — | — | — | — | — | 2033-09-15 | — |
| 9486426 | 2033-09-15 | — — | — | — | — | — | 2033-09-15 | — |
| 11426373 | 2037-09-19 | U U-3432 | — | — | — | — | — | — |
| 12138233 | 2041-02-22 | U U-4044 | — | — | — | — | — | — |
| 12582622 | 2041-02-22 | U U-4044 | — | — | — | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| ODE-361 | — | 2027-07-21 | — | — | — | — | Source | |
| PED | — | 2028-01-21 | — | — | — | — | Source | |
| ODE-369 | — | 2028-08-12 | — | — | — | — | 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. | ||||||
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.
| Event date | Party | Event | Licensed entry | Evidence | Source |
|---|---|---|---|---|---|
| 2026-03-01 | Granules | SETTLEMENT | Not disclosed | REVIEW | — |
| Entry date not publicly specified | |||||