Product profile · United States
NUPLAZID
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Official FDA evidence establishes Final ANDA approval for this exact reference product, dosage form and strength. Own 10 mg tablet Final ANDA 214502 confirmed independently. The FDA first-generic table has a brand-link caption inconsistency; the 10 mg tablet row, ANDA product record and CGT reference NDA 207318 resolve identity.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7659285 | 2026-08-24 | U U-1844 | N | Y | DS_EQUIVALENT | — | — | — |
| 7659285 | 2026-08-24 | U U-1844 | N | Y | DS_EQUIVALENT Independent claim 1 covers pimavanserin treatment of Parkinson disease psychosis without a formulation or CYP3A4 restriction. This is the entire current approved indication for both exact NUPLAZID products; no alternative approved indication supports a skinny-label carve-out. | — | — | — |
| 7732615 | 2028-06-03 | DS/DP — | N | N | CRYSTALLINE_TARTRATE | — | — | — |
| 7732615 | 2028-06-03 | DS/DP — | N | N | CRYSTALLINE_TARTRATE Independent claims restrict crystalline pimavanserin tartrate forms and form content or diffraction characteristics; the official DS flag does not remove these limitations. | — | — | — |
| 7732615 | 2028-12-03 | — — | — | — | — | — | 2028-12-03 | — |
| 7732615 | 2028-12-03 | PED — | N | N | CRYSTALLINE_TARTRATE Independent claims restrict crystalline pimavanserin tartrate forms and form content or diffraction characteristics; the official DS flag does not remove these limitations. PED row inherits its parent classification; the listed date is not extended again. | — | — | — |
| 7601740 | 2030-04-29 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 7601740 | 2030-04-29 | DS/DP — | Y | Y | TRUE_DS Independent claim 22 claims the pimavanserin structure or a pharmaceutically acceptable salt; claim 1 also covers its pharmaceutical composition without a crystal or process restriction. | — | — | — |
| 7601740 | 2030-10-29 | — — | — | — | — | — | 2030-10-29 | — |
| 7601740 | 2030-10-29 | PED — | Y | Y | TRUE_DS Independent claim 22 claims the pimavanserin structure or a pharmaceutically acceptable salt; claim 1 also covers its pharmaceutical composition without a crystal or process restriction. PED row inherits its parent classification; the listed date is not extended again. | — | — | — |
| 10517860 | 2037-03-23 | U U-1974 | N | N | CONCOMITANT_DRUG_RESTRICTED_USE | — | — | — |
| 10517860 | 2037-03-23 | U U-1974 | N | N | CONCOMITANT_DRUG_RESTRICTED_USE Independent claims restrict pimavanserin 10 mg treatment to concurrent specified strong CYP3A4 inhibitors. | — | — | — |
| 10953000 | 2037-03-23 | U U-1974 | N | N | CONCOMITANT_DRUG_DOSE_REDUCTION | — | — | — |
| 10953000 | 2037-03-23 | U U-1974 | N | N | CONCOMITANT_DRUG_DOSE_REDUCTION Independent claims require reduction from pimavanserin 34 mg to 10 mg with concurrent specified strong CYP3A4 inhibitors. | — | — | — |
| 10517860 | 2037-09-23 | — — | — | — | — | — | 2037-09-23 | — |
| 10517860 | 2037-09-23 | PED — | N | N | CONCOMITANT_DRUG_RESTRICTED_USE Independent claims restrict pimavanserin 10 mg treatment to concurrent specified strong CYP3A4 inhibitors. PED row inherits its parent classification; the listed date is not extended again. | — | — | — |
| 10953000 | 2037-09-23 | — — | — | — | — | — | 2037-09-23 | — |
| 10953000 | 2037-09-23 | PED — | N | N | CONCOMITANT_DRUG_DOSE_REDUCTION Independent claims require reduction from pimavanserin 34 mg to 10 mg with concurrent specified strong CYP3A4 inhibitors. PED row inherits its parent classification; the listed date is not extended again. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| M-14 | 2026-04-27 | 2029-04-27 | Additional clinical trial information in the pediatric-use subsection; no new pediatric indication was approved. | N | N | — | M-14 + PED
Full coverage date: —
| Source |
| M-14 | 2026-04-27 | 2029-04-27 | Additional clinical trial information in the pediatric-use subsection; no new pediatric indication was approved. | N | N | — | M-14 + PED
Full coverage date: —
| Source |
| PED | — | 2029-10-27 | Six-month pediatric extension attaches to the underlying right and does not independently expand its substantive scope. | N | N | — | M-14 + PED
Full coverage date: —
| Source |
| PED | — | 2029-10-27 | Six-month pediatric extension attaches to the underlying right and does not independently expand its substantive scope. | N | N | — | M-14 + PED
Full coverage date: —
| Source |
2026-10-11 · 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 |
|---|---|---|---|---|---|---|---|
| 214502 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-01-16 | — | ZYDUS WORLDWIDE DMCC | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 214502 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-01-16 | — | ZYDUS WORLDWIDE DMCC | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 214502 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2024-01-16 | — | ZYDUS WORLDWIDE DMCC | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 214502 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2024-01-16 | — | ZYDUS WORLDWIDE DMCC | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | 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 4 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 |
|---|---|---|---|---|---|---|
| 214502 / 001 | ZYDUS WORLDWIDE DMCC | FINAL_APPROVAL · FINAL_APPROVED | 2024-01-16 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 214502 / 001 | ZYDUS WORLDWIDE DMCC | FINAL_APPROVAL · FINAL_APPROVED | 2024-01-16 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 214502 / 001 | ZYDUS WORLDWIDE DMCC | FINAL_APPROVAL · FINAL_APPROVAL | 2024-01-16 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 214502 / 001 | ZYDUS WORLDWIDE DMCC | FINAL_APPROVAL · FINAL_APPROVAL | 2024-01-16 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
Decision evidence (13)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| GENERIC_APPROVAL | 2024-01-16 | DISQUALIFYING_FINAL_GENERIC | Exact Final ANDA214502/001 -> NDA207318/002 | Source |
| PATENT | 2026-08-24 | LISTING_CONTEXT | Independent claim 1 covers pimavanserin treatment of Parkinson disease psychosis without a formulation or CYP3A4 restriction. This is the entire current approved indication for both exact NUPLAZID products; no alternative approved indication supports a skinny-label carve-out. | Source |
| PATENT | 2028-06-03 | LISTING_CONTEXT | Independent claims restrict crystalline pimavanserin tartrate forms and form content or diffraction characteristics; the official DS flag does not remove these limitations. | Source |
| PATENT | 2028-12-03 | LISTING_CONTEXT | Independent claims restrict crystalline pimavanserin tartrate forms and form content or diffraction characteristics; the official DS flag does not remove these limitations. PED row inherits its parent classification; the listed date is not extended again. | Source |
| PATENT | 2030-04-29 | LISTING_CONTEXT | Independent claim 22 claims the pimavanserin structure or a pharmaceutically acceptable salt; claim 1 also covers its pharmaceutical composition without a crystal or process restriction. | Source |
| PATENT | 2030-10-29 | CANONICAL_ANCHOR | Independent claim 22 claims the pimavanserin structure or a pharmaceutically acceptable salt; claim 1 also covers its pharmaceutical composition without a crystal or process restriction. PED row inherits its parent classification; the listed date is not extended again. | Source |
| PATENT | 2037-03-23 | FTO_TAIL | Independent claims restrict pimavanserin 10 mg treatment to concurrent specified strong CYP3A4 inhibitors. | Source |
| PATENT | 2037-03-23 | FTO_TAIL | Independent claims require reduction from pimavanserin 34 mg to 10 mg with concurrent specified strong CYP3A4 inhibitors. | Source |
| PATENT | 2037-09-23 | FTO_TAIL | Independent claims restrict pimavanserin 10 mg treatment to concurrent specified strong CYP3A4 inhibitors. PED row inherits its parent classification; the listed date is not extended again. | Source |
| PATENT | 2037-09-23 | FTO_TAIL | Independent claims require reduction from pimavanserin 34 mg to 10 mg with concurrent specified strong CYP3A4 inhibitors. PED row inherits its parent classification; the listed date is not extended again. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Six-month pediatric extension attaches to the underlying right and does not independently expand its substantive scope. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Additional clinical trial information in the pediatric-use subsection; no new pediatric indication was approved. | Source |
| REGULATORY_STATUS | 2024-01-16 | DECISION_BASIS | Official FDA evidence establishes Final ANDA approval for this exact reference product, dosage form and strength. Own 10 mg tablet Final ANDA 214502 confirmed independently. The FDA first-generic table has a brand-link caption inconsistency; the 10 mg tablet row, ANDA product record and CGT reference NDA 207318 resolve identity. | 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.