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. 34 mg capsule Final ANDA 214925 confirmed by the FDA first-generic table. An older linked tentative-approval PDF does not override the later official Final approval record.
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. | — | — | — |
| 10449185 | 2038-08-27 | DP — | N | N | CAPSULE_FORMULATION | — | — | — |
| 10449185 | 2038-08-27 | DP — | N | N | CAPSULE_FORMULATION Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. | — | — | — |
| 10646480 | 2038-08-27 | DP — | N | N | CAPSULE_FORMULATION | — | — | — |
| 10646480 | 2038-08-27 | DP — | N | N | CAPSULE_FORMULATION Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. | — | — | — |
| 10849891 | 2038-08-27 | DP/U U-1974 | N | N | CAPSULE_FORMULATION | — | — | — |
| 10849891 | 2038-08-27 | DP/U U-1974 | N | N | CAPSULE_FORMULATION Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. | — | — | — |
| 11452721 | 2038-08-27 | DP — | N | N | CAPSULE_FORMULATION | — | — | — |
| 11452721 | 2038-08-27 | DP — | N | N | CAPSULE_FORMULATION Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. | — | — | — |
| 10449185 | 2039-02-27 | — — | — | — | — | — | 2039-02-27 | — |
| 10449185 | 2039-02-27 | PED — | N | N | CAPSULE_FORMULATION Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. PED row inherits its parent classification; the listed date is not extended again. | — | — | — |
| 10646480 | 2039-02-27 | — — | — | — | — | — | 2039-02-27 | — |
| 10646480 | 2039-02-27 | PED — | N | N | CAPSULE_FORMULATION Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. PED row inherits its parent classification; the listed date is not extended again. | — | — | — |
| 10849891 | 2039-02-27 | — — | — | — | — | — | 2039-02-27 | — |
| 10849891 | 2039-02-27 | PED — | N | N | CAPSULE_FORMULATION Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. PED row inherits its parent classification; the listed date is not extended again. | — | — | — |
| 11452721 | 2039-02-27 | — — | — | — | — | — | 2039-02-27 | — |
| 11452721 | 2039-02-27 | PED — | N | N | CAPSULE_FORMULATION Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. 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 |
|---|---|---|---|---|---|---|---|
| 214493 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-01-16 | — | ZYDUS WORLDWIDE DMCC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214925 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-01-16 | — | MSN LABORATORIES PRIVATE LTD | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 214925 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-01-16 | — | MSN LABORATORIES PRIVATE LTD | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 214925 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2024-01-16 | — | MSN LABORATORIES PRIVATE LTD | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 214925 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2024-01-16 | — | MSN LABORATORIES PRIVATE LTD | 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 5 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 |
|---|---|---|---|---|---|---|
| 214493 / 001 | ZYDUS WORLDWIDE DMCC | FINAL_APPROVAL · FINAL_APPROVED | 2024-01-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 214925 / 001 | MSN LABORATORIES PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2024-01-16 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 214925 / 001 | MSN LABORATORIES PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2024-01-16 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 214925 / 001 | MSN LABORATORIES PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVAL | 2024-01-16 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 214925 / 001 | MSN LABORATORIES PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVAL | 2024-01-16 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
Decision evidence (17)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| GENERIC_APPROVAL | 2024-01-16 | DISQUALIFYING_FINAL_GENERIC | Exact Final ANDA214925/001 -> NDA210793/001 | 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 | 2038-08-27 | FTO_TAIL | Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. | Source |
| PATENT | 2038-08-27 | FTO_TAIL | Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. | Source |
| PATENT | 2038-08-27 | FTO_TAIL | Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. | Source |
| PATENT | 2038-08-27 | FTO_TAIL | Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. | Source |
| PATENT | 2039-02-27 | FTO_TAIL | Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. PED row inherits its parent classification; the listed date is not extended again. | Source |
| PATENT | 2039-02-27 | FTO_TAIL | Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. PED row inherits its parent classification; the listed date is not extended again. | Source |
| PATENT | 2039-02-27 | FTO_TAIL | Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. PED row inherits its parent classification; the listed date is not extended again. | Source |
| PATENT | 2039-02-27 | FTO_TAIL | Independent claims restrict 34 mg pimavanserin capsules to shell size, granulated tartrate density and/or particle size and specified excipients. They do not protect the molecule without those restrictions. 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. 34 mg capsule Final ANDA 214925 confirmed by the FDA first-generic table. An older linked tentative-approval PDF does not override the later official Final approval record. | 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.