CTEXLI
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
ODE-523 covers the sole approved indication, adult CTX, and expires 2032-02-21, later than NP expiry 2028-02-21. ANDA091019 references Chenix/gallstones and is not direct CTEXLI generic evidence. Evidence limits: complete historical patent/exclusivity collection remains incomplete.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| No patent facts are recorded for this product. | ||||||||
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | — | 2028-02-21 | — | — | — | — | Source | |
| NP | 2025-02-21 | 2028-02-21 | NDA219488/product001; sole approved indication: adult cerebrotendinous xanthomatosis. | Y | Y | 2032-02-21 | NP + ODE-523
Full coverage date: 2032-02-21
| Source |
| ODE-523 | — | 2032-02-21 | — | — | — | — | Source | |
| ODE-523 | 2025-02-21 | 2032-02-21 | NDA219488/product001; sole approved indication: adult cerebrotendinous xanthomatosis. | Y | Y | 2032-02-21 | NP + ODE-523
Full coverage date: 2032-02-21
| Source |
2026-10-10 · CURRENT_SNAPSHOT_RECORDS · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 091019 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2009-10-22 | — | LGM PHARMA SOLUTIONS LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | 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 |
|---|---|---|---|---|---|---|
| 091019 / 001 | LGM PHARMA SOLUTIONS LLC | FINAL_APPROVAL · FINAL_APPROVED | 2009-10-22 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (2)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| REGULATORY_EXCLUSIVITY | 2032-02-21 | CANONICAL_ANCHOR | ODE independently covers sole approved adult CTX indication. NP overlaps until2028-02-21; meaningful full coverage2032-02-21. | Source |
| REGULATORY_EXCLUSIVITY | 2032-02-21 | OVERLAPPING_PROTECTION | ODE independently covers sole approved adult CTX indication. NP overlaps until2028-02-21; meaningful full coverage2032-02-21. | 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.