SIKLOS
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
No verified direct-reference Final ANDA or unrestricted TrueDS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. ANDA 075734 was approved in 2000, seventeen years before SIKLOS NDA 208843. Matching hydroxyurea and 1000 mg does not establish a SIKLOS reference. No direct-reference Final ANDA is established. Historical regulatory exclusivity records have been recovered and scope-reviewed; absence in the current snapshot is not treated as absence of history. The FDA 2025 S-005 action is Tentative Approval, not a Final-approved indication expansion; XROMI protection affecting that pending expansion is not this product's full-scope anchor.
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 | 2017-12-21 | 2020-12-21 | Original pediatric sickle-cell anemia indication, patients aged 2 years and older; it does not cover the adult population added in 2021. | N | N | — | NP:2020-12-21 + ODE-177:2024-12-21
Full coverage date: —
Adult patients added by the 2021 Final approval | Source |
| ODE-177 | 2017-12-21 | 2024-12-21 | Original pediatric sickle-cell anemia indication, patients aged 2 years and older; it does not cover the adult population added in 2021. | N | N | — | NP:2020-12-21 + ODE-177:2024-12-21
Full coverage date: —
Adult patients added by the 2021 Final approval | Source |
2026-10-11 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 075734 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2000-08-29 | — | BARR LABORATORIES INC | 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 |
|---|---|---|---|---|---|---|
| 075734 / 001 | BARR LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2000-08-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (3)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Original pediatric sickle-cell anemia indication, patients aged 2 years and older; it does not cover the adult population added in 2021. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Original pediatric sickle-cell anemia indication, patients aged 2 years and older; it does not cover the adult population added in 2021. | Source |
| REGULATORY_STATUS | 2017-12-21 | DECISION_BASIS | No verified direct-reference Final ANDA or unrestricted TrueDS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. ANDA 075734 was approved in 2000, seventeen years before SIKLOS NDA 208843. Matching hydroxyurea and 1000 mg does not establish a SIKLOS reference. No direct-reference Final ANDA is established. Historical regulatory exclusivity records have been recovered and scope-reviewed; absence in the current snapshot is not treated as absence of history. The FDA 2025 S-005 action is Tentative Approval, not a Final-approved indication expansion; XROMI protection affecting that pending expansion is not this product's full-scope anchor. | 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.