Product profile · United States
CAPLYTA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2033. Anchor type: PATENT. Patent anchor: 2033-08-19. Exclusivity anchor: 2024-12-20. Anchor date: 2033-08-19. Patent tail: yes. Exclusivity tail: no. Review status: FINAL. 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 |
|---|---|---|---|---|---|---|---|---|
| 10464938 | 2028-03-12 | DP — | N | Y | U English description not available. | — | — | — |
| 10464938 | 2028-03-12 | ORANGE_BOOK — | N | Y | U English description not available. | — | — | — |
| 9199995 | 2029-03-12 | U U-2713 | N | N | U English description not available. | — | — | — |
| 9199995 | 2029-03-12 | U U-4343 | N | N | U English description not available. | — | — | — |
| 9199995 | 2029-03-12 | ORANGE_BOOK U-2713;U-4343 | N | N | U English description not available. | — | — | — |
| RE48825 | 2029-03-12 | DS — | N | N | DP English description not available. | — | — | — |
| RE48825 | 2029-03-12 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 10117867 | 2029-05-27 | U U-3271 | N | N | U English description not available. | — | — | — |
| 10117867 | 2029-05-27 | ORANGE_BOOK U-3271 | N | N | U English description not available. | — | — | — |
| 9168258 | 2029-05-27 | DP — | N | N | DP English description not available. | — | — | — |
| 9168258 | 2029-05-27 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 9616061 | 2029-05-27 | DP — | N | N | DP English description not available. | — | — | — |
| 9616061 | 2029-05-27 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| 8648077 | 2029-12-01 | DS/DP — | N | N | DP English description not available. | — | — | — |
| 8648077 | 2029-12-01 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
| RE48839 | 2033-08-19 | U U-3271 | N | Y | U English description not available. | — | — | — |
| RE48839 | 2033-08-19 | U U-4344 | N | Y | U English description not available. | — | — | — |
| RE48839 | 2033-08-19 | U U-814 | N | Y | U English description not available. | — | — | — |
| RE48839 | 2033-08-19 | ORANGE_BOOK U-3271;U-4344;U-814 | N | Y | U English description not available. | — | — | — |
| 11026951 | 2034-12-03 | U U-3364 | N | N | U English description not available. | — | — | — |
| 11026951 | 2034-12-03 | ORANGE_BOOK U-3364 | N | N | U English description not available. | — | — | — |
| 9956227 | 2034-12-03 | U U-2714 | N | N | U English description not available. | — | — | — |
| 9956227 | 2034-12-03 | ORANGE_BOOK U-2714 | N | N | U English description not available. | — | — | — |
| 12409176 | 2039-03-15 | U U-4261 | N | N | U English description not available. | — | — | — |
| 12409176 | 2039-03-15 | ORANGE_BOOK U-4261 | N | N | U English description not available. | — | — | — |
| 10695345 | 2039-08-30 | DP/U U-814 | N | N | DP English description not available. | — | — | — |
| 10695345 | 2039-08-30 | ORANGE_BOOK U-814 | N | N | DP English description not available. | — | — | — |
| 11052084 | 2039-08-30 | DP/U U-3362 | N | N | DP English description not available. | — | — | — |
| 11052084 | 2039-08-30 | DP/U U-3363 | N | N | DP English description not available. | — | — | — |
| 11052084 | 2039-08-30 | DP/U U-4341 | N | N | DP English description not available. | — | — | — |
| 11052084 | 2039-08-30 | ORANGE_BOOK U-3362;U-3363;U-4341 | N | N | DP English description not available. | — | — | — |
| 11690842 | 2039-08-30 | DP/U U-3362 | N | N | DP English description not available. | — | — | — |
| 11690842 | 2039-08-30 | DP/U U-4341 | N | N | DP English description not available. | — | — | — |
| 11690842 | 2039-08-30 | DP/U U-3363 | N | N | DP English description not available. | — | — | — |
| 11690842 | 2039-08-30 | ORANGE_BOOK U-3362;U-3363;U-4341 | N | N | DP English description not available. | — | — | — |
| 11806348 | 2039-08-30 | DP/U U-3363 | N | N | U English description not available. | — | — | — |
| 11806348 | 2039-08-30 | DP/U U-3362 | N | N | U English description not available. | — | — | — |
| 11806348 | 2039-08-30 | DP/U U-4341 | N | N | U English description not available. | — | — | — |
| 11806348 | 2039-08-30 | ORANGE_BOOK U-3362;U-3363;U-4341 | N | N | U English description not available. | — | — | — |
| 11980617 | 2039-10-27 | U U-3940 | N | N | U English description not available. | — | — | — |
| 11980617 | 2039-10-27 | U U-4342 | N | N | U English description not available. | — | — | — |
| 11980617 | 2039-10-27 | ORANGE_BOOK U-3940;U-4342 | N | N | U English description not available. | — | — | — |
| 11753419 | 2040-12-10 | DP — | N | N | OTHER English description not available. | — | — | — |
| 11753419 | 2040-12-10 | ORANGE_BOOK — | N | N | OTHER English description not available. | — | — | — |
| 12122792 | 2040-12-10 | DP/U U-4340 | N | N | DP English description not available. | — | — | — |
| 12122792 | 2040-12-10 | DP/U U-4020 | N | N | DP English description not available. | — | — | — |
| 12122792 | 2040-12-10 | DP/U U-4019 | N | N | DP English description not available. | — | — | — |
| 12122792 | 2040-12-10 | ORANGE_BOOK U-4019;U-4020;U-4340 | N | N | DP English description not available. | — | — | — |
| 12410195 | 2040-12-10 | DP — | N | N | DP English description not available. | — | — | — |
| 12410195 | 2040-12-10 | ORANGE_BOOK — | N | N | DP English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2019-12-20 | 2024-12-20 | English description not available. | Y | Y | 2024-12-20 | NCE
Full coverage date: 2024-12-20
| Source |
| I-904 | 2025-11-05 | 2028-11-05 | English description not available. | N | N | — | — | Source |
| I-904 | 2025-11-05 | 2028-11-05 | English description not available. | N | N | — | NCE
Full coverage date: —
| Source |
| M-319 | 2026-04-24 | 2029-04-24 | English description not available. | N | N | — | — | Source |
| M-319 | 2026-04-24 | 2029-04-24 | English description not available. | N | N | — | NCE
Full coverage date: —
| 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 (23)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2028-03-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2029-03-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2029-03-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2029-05-27 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2029-05-27 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2029-05-27 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2029-12-01 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-08-19 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2034-12-03 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-12-03 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-03-15 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-08-30 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-08-30 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-08-30 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-08-30 | FTO_TAIL | English description not available. | Source |
| PATENT | 2039-10-27 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-12-10 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-12-10 | FTO_TAIL | English description not available. | Source |
| PATENT | 2040-12-10 | FTO_TAIL | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | 2033-08-19 | CANONICAL_DECISION | English description not available. | Source |
Independent legal-event information
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.