Product profile · United States
TRINTELLIX
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Rights after the canonical full-scope anchor require DEEP_REVIEW.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7144884 | 2026-06-17 | DS/DP/U U-1439 | Y | Y | TRUE_DS | — | — | — |
| 7144884 | 2026-06-17 | DS/DP/U U-1439 | Y | Y | TRUE_DS Compound genus and independent claim 5 explicitly include vortioxetine by chemical name; no form or indication limit. | — | — | — |
| 7144884 | 2026-12-17 | — — | Y | Y | TRUE_DS | — | 2026-12-17 | — |
| 7144884 | 2026-12-17 | PED — | Y | Y | TRUE_DS Compound genus and independent claim 5 explicitly include vortioxetine by chemical name; no form or indication limit. | — | — | — |
| 11458134 | 2027-06-15 | DP/U U-3463 | N | N | CRYSTAL_FORMULATION | — | — | — |
| 11458134 | 2027-06-15 | DP/U U-3463 | N | N | CRYSTAL_FORMULATION Vortioxetine HBr crystal XRPD and named excipients; use claims depend on that composition. | — | — | — |
| 8969355 | 2027-06-15 | U U-1668 | N | N | CRYSTAL_USE | — | — | — |
| 8969355 | 2027-06-15 | U U-1668 | N | N | CRYSTAL_USE Vortioxetine disease-treatment claims require specified crystalline HBr XRPD or crystal-pattern forms. | — | — | — |
| 9125908 | 2027-06-15 | U U-2309 | N | N | LIMITED_USE | — | — | — |
| 9125908 | 2027-06-15 | U U-2309 | N | N | LIMITED_USE Vortioxetine cognitive-impairment treatment in depressed patients, with crystalline form and dose constraints; not all MDD patients. | — | — | — |
| 9125909 | 2027-06-15 | U U-2309 | N | N | LIMITED_CRYSTAL_USE | — | — | — |
| 9125909 | 2027-06-15 | U U-2309 | N | N | LIMITED_CRYSTAL_USE Cognitive-impairment treatment in depressed patients using crystalline vortioxetine; not unrestricted all-MDD protection. | — | — | — |
| 9125910 | 2027-06-15 | U U-2309 | N | N | LIMITED_USE | — | — | — |
| 9125910 | 2027-06-15 | U U-2309 | N | N | LIMITED_USE Vortioxetine cognitive-impairment treatment in depressed patients; not all MDD patients despite absence of crystal restriction. | — | — | — |
| 9227946 | 2027-06-15 | U U-1668 | N | N | CRYSTAL_USE | — | — | — |
| 9227946 | 2027-06-15 | U U-1668 | N | N | CRYSTAL_USE Vortioxetine treatment requires crystalline HBr salt defined by specified XRPD reflections. | — | — | — |
| 9861630 | 2027-06-15 | U U-1668 | N | N | CRYSTAL_RESTRICTED_USE | — | — | — |
| 9861630 | 2027-06-15 | U U-1668 | N | N | CRYSTAL_RESTRICTED_USE MDD treatment claims require listed crystalline vortioxetine hydrobromide forms, solvates or mixtures; unrestricted indication wording does not remove material-form limitations. | — | — | — |
| 11458134 | 2027-12-15 | — — | N | N | CRYSTAL_FORMULATION | — | 2027-12-15 | — |
| 11458134 | 2027-12-15 | PED — | N | N | CRYSTAL_FORMULATION Vortioxetine HBr crystal XRPD and named excipients; use claims depend on that composition. | — | — | — |
| 8969355 | 2027-12-15 | — — | N | N | CRYSTAL_USE | — | 2027-12-15 | — |
| 8969355 | 2027-12-15 | PED — | N | N | CRYSTAL_USE Vortioxetine disease-treatment claims require specified crystalline HBr XRPD or crystal-pattern forms. | — | — | — |
| 9125908 | 2027-12-15 | — — | N | N | LIMITED_USE | — | 2027-12-15 | — |
| 9125908 | 2027-12-15 | PED — | N | N | LIMITED_USE Vortioxetine cognitive-impairment treatment in depressed patients, with crystalline form and dose constraints; not all MDD patients. | — | — | — |
| 9125909 | 2027-12-15 | — — | N | N | LIMITED_CRYSTAL_USE | — | 2027-12-15 | — |
| 9125909 | 2027-12-15 | PED — | N | N | LIMITED_CRYSTAL_USE Cognitive-impairment treatment in depressed patients using crystalline vortioxetine; not unrestricted all-MDD protection. | — | — | — |
| 9125910 | 2027-12-15 | — — | N | N | LIMITED_USE | — | 2027-12-15 | — |
| 9125910 | 2027-12-15 | PED — | N | N | LIMITED_USE Vortioxetine cognitive-impairment treatment in depressed patients; not all MDD patients despite absence of crystal restriction. | — | — | — |
| 9227946 | 2027-12-15 | — — | N | N | CRYSTAL_USE | — | 2027-12-15 | — |
| 9227946 | 2027-12-15 | PED — | N | N | CRYSTAL_USE Vortioxetine treatment requires crystalline HBr salt defined by specified XRPD reflections. | — | — | — |
| 9861630 | 2027-12-15 | — — | N | N | CRYSTAL_RESTRICTED_USE | — | 2027-12-15 | — |
| 9861630 | 2027-12-15 | PED — | N | N | CRYSTAL_RESTRICTED_USE MDD treatment claims require listed crystalline vortioxetine hydrobromide forms, solvates or mixtures; unrestricted indication wording does not remove material-form limitations. | — | — | — |
| 8722684 | 2031-06-30 | DS/DP — | N | N | CRYSTAL | — | — | — |
| 8722684 | 2031-06-30 | DS/DP — | N | N | CRYSTAL Vortioxetine or salt restricted by crystalline XRPD patterns; independent HBr claim also crystal-limited. | — | — | — |
| 8722684 | 2031-12-30 | — — | N | N | CRYSTAL | — | 2031-12-30 | — |
| 8722684 | 2031-12-30 | PED — | N | N | CRYSTAL Vortioxetine or salt restricted by crystalline XRPD patterns; independent HBr claim also crystal-limited. | — | — | — |
| 9278096 | 2032-03-21 | U U-2436 | N | N | LIMITED_USE | — | — | — |
| 9278096 | 2032-03-21 | U U-2436 | N | N | LIMITED_USE Vortioxetine switches after prior antidepressant sexual or sleep adverse events; not all MDD patients. | — | — | — |
| 9278096 | 2032-09-21 | — — | N | N | LIMITED_USE | — | 2032-09-21 | — |
| 9278096 | 2032-09-21 | PED — | N | N | LIMITED_USE Vortioxetine switches after prior antidepressant sexual or sleep adverse events; not all MDD patients. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2013-09-30 | 2018-09-30 | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Y | Y | 2018-09-30 | M-187 + M-232 + PED
Full coverage date: 2018-09-30
| Source |
| M-227 | 2018-05-02 | 2021-05-02 | ADDITION TO THE CLINICAL STUDIES SECTION OF THE LABELING WITH THE SUBSECTION ENTITLED DIGIT SYMBOL SUBSTITUTION TEST IN MAJOR DEPRESSIVE DISORDER | N | N | — | M-187 + M-232 + PED
Full coverage date: —
| Source |
| M-234 | 2018-10-19 | 2021-10-19 | UPDATE TO THE PRESCRIBING INFORMATION FOR VORTIOXETINE ON TREATMENT-EMERGENT SEXUAL DYSFUNCTION COMPARING VORTIOXETINE AND SSRIS | N | N | — | M-187 + M-232 + PED
Full coverage date: —
| Source |
| M-267 | 2020-11-13 | 2023-11-13 | INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY LUAA21004-402 | N | N | — | M-187 + M-232 + PED
Full coverage date: —
| Source |
| M-187 | 2021-01-22 | 2024-01-22 | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING | N | N | — | M-187 + M-232 + PED
Full coverage date: —
| Source |
| M-232 | 2023-08-23 | 2026-08-23 | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES | N | N | — | M-187 + M-232 + PED
Full coverage date: —
| Source |
| M-232 | 2023-08-23 | 2026-08-23 | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES | N | N | — | M-187 + M-232 + PED
Full coverage date: —
| Source |
| PED | 2026-08-23 | 2027-02-23 | Six-month extension of M-232: INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES | N | N | — | M-187 + M-232 + PED
Full coverage date: —
| Source |
| PED | 2026-08-23 | 2027-02-23 | Six-month extension of M-232: INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES | N | N | — | M-187 + M-232 + PED
Full coverage date: —
| Source |
2026-10-11 · CURRENT_AND_HISTORICAL_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 |
|---|---|---|---|---|---|---|---|
| 211146 / 002 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | ZYDUS PHARMS | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | 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 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 (28)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2026-06-17 | LISTING_CONTEXT | Compound genus and independent claim 5 explicitly include vortioxetine by chemical name; no form or indication limit. | Source |
| PATENT | 2026-12-17 | CANONICAL_ANCHOR | Compound genus and independent claim 5 explicitly include vortioxetine by chemical name; no form or indication limit. | Source |
| PATENT | 2027-06-15 | FTO_TAIL | Vortioxetine HBr crystal XRPD and named excipients; use claims depend on that composition. | Source |
| PATENT | 2027-06-15 | FTO_TAIL | Vortioxetine disease-treatment claims require specified crystalline HBr XRPD or crystal-pattern forms. | Source |
| PATENT | 2027-06-15 | FTO_TAIL | Vortioxetine cognitive-impairment treatment in depressed patients, with crystalline form and dose constraints; not all MDD patients. | Source |
| PATENT | 2027-06-15 | FTO_TAIL | MDD treatment claims require listed crystalline vortioxetine hydrobromide forms, solvates or mixtures; unrestricted indication wording does not remove material-form limitations. | Source |
| PATENT | 2027-06-15 | FTO_TAIL | Vortioxetine cognitive-impairment treatment in depressed patients; not all MDD patients despite absence of crystal restriction. | Source |
| PATENT | 2027-06-15 | FTO_TAIL | Cognitive-impairment treatment in depressed patients using crystalline vortioxetine; not unrestricted all-MDD protection. | Source |
| PATENT | 2027-06-15 | FTO_TAIL | Vortioxetine treatment requires crystalline HBr salt defined by specified XRPD reflections. | Source |
| PATENT | 2027-12-15 | FTO_TAIL | Cognitive-impairment treatment in depressed patients using crystalline vortioxetine; not unrestricted all-MDD protection. | Source |
| PATENT | 2027-12-15 | FTO_TAIL | Vortioxetine treatment requires crystalline HBr salt defined by specified XRPD reflections. | Source |
| PATENT | 2027-12-15 | FTO_TAIL | Vortioxetine cognitive-impairment treatment in depressed patients, with crystalline form and dose constraints; not all MDD patients. | Source |
| PATENT | 2027-12-15 | FTO_TAIL | Vortioxetine disease-treatment claims require specified crystalline HBr XRPD or crystal-pattern forms. | Source |
| PATENT | 2027-12-15 | FTO_TAIL | MDD treatment claims require listed crystalline vortioxetine hydrobromide forms, solvates or mixtures; unrestricted indication wording does not remove material-form limitations. | Source |
| PATENT | 2027-12-15 | FTO_TAIL | Vortioxetine cognitive-impairment treatment in depressed patients; not all MDD patients despite absence of crystal restriction. | Source |
| PATENT | 2027-12-15 | FTO_TAIL | Vortioxetine HBr crystal XRPD and named excipients; use claims depend on that composition. | Source |
| PATENT | 2031-06-30 | FTO_TAIL | Vortioxetine or salt restricted by crystalline XRPD patterns; independent HBr claim also crystal-limited. | Source |
| PATENT | 2031-12-30 | FTO_TAIL | Vortioxetine or salt restricted by crystalline XRPD patterns; independent HBr claim also crystal-limited. | Source |
| PATENT | 2032-03-21 | FTO_TAIL | Vortioxetine switches after prior antidepressant sexual or sleep adverse events; not all MDD patients. | Source |
| PATENT | 2032-09-21 | FTO_TAIL | Vortioxetine switches after prior antidepressant sexual or sleep adverse events; not all MDD patients. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | ADDITION TO THE CLINICAL STUDIES SECTION OF THE LABELING WITH THE SUBSECTION ENTITLED DIGIT SYMBOL SUBSTITUTION TEST IN MAJOR DEPRESSIVE DISORDER | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY LUAA21004-402 | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Six-month extension of M-232: INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | UPDATE TO THE PRESCRIBING INFORMATION FOR VORTIOXETINE ON TREATMENT-EMERGENT SEXUAL DYSFUNCTION COMPARING VORTIOXETINE AND SSRIS | Source |
| REGULATORY_EXCLUSIVITY | 2018-09-30 | CANONICAL_ANCHOR | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Source |
| REGULATORY_STATUS | 2026-12-17 | DECISION_BASIS | Rights after the canonical full-scope anchor require DEEP_REVIEW. | 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.