Spevigo
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: CANDIDATE. Reference year: 2035. Anchor type: DRUG_SUBSTANCE. Patent anchor: 2035-09-22. Exclusivity anchor: 2034-09-01. Anchor date: 2035-09-22. 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 |
|---|---|---|---|---|---|---|---|---|
| US9023995 | 2035-09-22 | — — | 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 | 2022-09-01 | 2029-09-01 | Treatment of generalized pustular psoriasis (GPP) flares in adults | — | — | — | — | Source |
| ODE | 2024-03-18 | 2031-03-18 | treatment of generalized pustular psoriasis (GPP) flares in pediatric patients 12 years of age and older and weighing at least 40 kg, and treatment of GPP in adults and pediatric patients 12 years of age and older and weighing at least 40 kg who are not experiencing a flare | — | — | — | — | Source |
| Orphan Exclusivity Exp. Date | — | 2031-03-18 | — | — | — | — | Source | |
| RPE | 2022-09-01 | 2034-09-01 | 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 (4)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2035-09-22 | ANCHOR_REFERENCE | Product scope reviewed; reference date only; current official term verification pending | Source |
| REGULATORY_EXCLUSIVITY | 2029-09-01 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2031-03-18 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2034-09-01 | 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.