Evkeeza
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: CANDIDATE. Reference year: 2035. Anchor type: DRUG_SUBSTANCE. Patent anchor: 2035-02-11. Exclusivity anchor: 2033-02-11. Anchor date: 2035-02-11. Patent tail: no. Exclusivity tail: not established. 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 |
|---|---|---|---|---|---|---|---|---|
| US9018356 | 2035-02-11 | — — | Y | N | TRUE_DS {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"TRUE_DS","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"} | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| ODE | 2021-02-11 | 2028-02-11 | adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH) | — | — | — | — | Source |
| ODE | 2023-03-21 | 2030-03-21 | as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of pediatric patients, aged 5 years to less than 12 years, with homozygous familial hypercholesterolemia (HoFH) | — | — | — | — | Source |
| Orphan Exclusivity Exp. Date | — | 2030-03-21 | — | — | — | — | Source | |
| ODE | 2025-09-25 | 2032-09-25 | as an adjunct to diet and exercise and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies to reduce LDL-C in pediatric patients, aged 1 year to less than 5 years, with homozygous familial hypercholesterolemia (HoFH) | — | — | — | — | Source |
| RPE | 2021-02-11 | 2033-02-11 | Full-product 12-year operational assumption; not FDA determination | Y | Y | — | — | 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. | ||||||
Decision evidence (5)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2035-02-11 | ANCHOR_REFERENCE | Product scope reviewed; reference date only; current official term verification pending | Source |
| REGULATORY_EXCLUSIVITY | 2028-02-11 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2030-03-21 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2032-09-25 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2033-02-11 | SCOPE_HISTORY | First approval + 12 years; operational assumption, not FDA determination | 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.