XURIDEN
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
QUALIFYING_ANCHOR_WITH_LATER_RIGHTS; canonical 2022 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US6258795 | 2023-07-10 | DP — | N | N | DP Issued claim1 excludes acetyl substituents through its C5-C22 fatty-acid limitation; formulaI substance claim2 requires an additional N-acyl substituent. The 2002-06-11 USPTO certificate corrects claim9 dependency from claim1 to claim10. Tri-O-acetyl uridine therefore appears in a pharmaceutical-composition claim requiring carrier and specified oral dosage form, not an unrestricted uridine-triacetate compound claim. XURIDEN oral granules/suspension are assessed as formulation protection; no TRUE_DS or DS-equivalent anchor adopted. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2015-09-04 | 2020-09-04 | FULL_ACTIVE_MOIETY_SCOPE; Both NCE and ODE-98 qualify; choose the later ODE date2022-09-04. Hereditary orotic aciduria is the sole approved disease. Later administration/label changes do not add another disease. | Y | Y | 2020-09-04 | Source | |
| ODE-98 | 2015-09-04 | 2022-09-04 | FULL_EXACT_PRODUCT_APPROVED_SCOPE; Both NCE and ODE-98 qualify; choose the later ODE date2022-09-04. Hereditary orotic aciduria is the sole approved disease. Later administration/label changes do not add another disease. | Y | Y | 2022-09-04 | Source |
2026-10-12 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_2011_2026_REVIEWED
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 (4)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2023-07-10 | FTO_TAIL | Issued claim1 excludes acetyl substituents through its C5-C22 fatty-acid limitation; formulaI substance claim2 requires an additional N-acyl substituent. The 2002-06-11 USPTO certificate corrects claim9 dependency from claim1 to claim10. Tri-O-acetyl uridine therefore appears in a pharmaceutical-composition claim requiring carrier and specified oral dosage form, not an unrestricted uridine-triacetate compound claim. XURIDEN oral granules/suspension are assessed as formulation protection; no TRUE_DS or DS-equivalent anchor adopted. | Source |
| REGULATORY_EXCLUSIVITY | 2020-09-04 | SCOPE_CONTEXT | FULL_ACTIVE_MOIETY_SCOPE; Both NCE and ODE-98 qualify; choose the later ODE date2022-09-04. Hereditary orotic aciduria is the sole approved disease. Later administration/label changes do not add another disease. | Source |
| REGULATORY_EXCLUSIVITY | 2022-09-04 | CANONICAL_ANCHOR | FULL_EXACT_PRODUCT_APPROVED_SCOPE; Both NCE and ODE-98 qualify; choose the later ODE date2022-09-04. Hereditary orotic aciduria is the sole approved disease. Later administration/label changes do not add another disease. | Source |
| REGULATORY_STATUS | 2022-09-04 | DECISION_BASIS | QUALIFYING_ANCHOR_WITH_LATER_RIGHTS; canonical 2022 DEEP_REVIEW; QUALIFYING_ANCHOR_WITH_LATER_RIGHTS. | 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.