Product profile · United States

TRINTELLIX

· Patent Litigation & Settlement History ↓

IngredientVORTIOXETINE HYDROBROMIDE

Application typeNDA

Application204447

Product003

Dosage formTABLET

RouteORAL

StrengthEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval date2013-09-30

Marketing statusDISCONTINUED

Status event—

ApplicantTAKEDA PHARMS USA

Product source

Current GenericRadar decision

Year2017

SelectionDISQUALIFIED

ReviewFINAL

Anchor typeFDA_DISCONTINUATION

Anchor date—

Patent anchor2026-12-17

Exclusivity anchor2018-09-30

Protection date2032-09-21

First Final ANDA—

Status event—

FDA DISC action month 2017-03; never marketed; Final exact ANDA link not identified; not certified generic absence.

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	—	—	—	—	—	—
7144884	2026-12-17	— —	—	—	—	—	2026-12-17	—
7144884	2026-12-17	ORANGE_BOOK U-1439	Y	N	TRUE_DS English description not available.	—	2026-12-17	—
11458134	2027-06-15	DP/U U-3463	—	—	—	—	—	—
8969355	2027-06-15	U U-1668	—	—	—	—	—	—
9125908	2027-06-15	U U-2309	—	—	—	—	—	—
9125909	2027-06-15	U U-2309	—	—	—	—	—	—
9125910	2027-06-15	U U-2309	—	—	—	—	—	—
9227946	2027-06-15	U U-1668	—	—	—	—	—	—
9861630	2027-06-15	U U-1668	—	—	—	—	—	—
11458134	2027-12-15	— —	—	—	—	—	2027-12-15	—
11458134	2027-12-15	ORANGE_BOOK U-3463	N	N	DP English description not available.	—	2027-12-15	—
8969355	2027-12-15	— —	—	—	—	—	2027-12-15	—
8969355	2027-12-15	ORANGE_BOOK U-1668	N	N	U English description not available.	—	2027-12-15	—
9125908	2027-12-15	— —	—	—	—	—	2027-12-15	—
9125908	2027-12-15	ORANGE_BOOK U-2309	N	N	U English description not available.	—	2027-12-15	—
9125909	2027-12-15	— —	—	—	—	—	2027-12-15	—
9125909	2027-12-15	ORANGE_BOOK U-2309	N	N	U English description not available.	—	2027-12-15	—
9125910	2027-12-15	— —	—	—	—	—	2027-12-15	—
9125910	2027-12-15	ORANGE_BOOK U-2309	N	N	U English description not available.	—	2027-12-15	—
9227946	2027-12-15	— —	—	—	—	—	2027-12-15	—
9227946	2027-12-15	ORANGE_BOOK U-1668	N	N	U English description not available.	—	2027-12-15	—
9861630	2027-12-15	— —	—	—	—	—	2027-12-15	—
9861630	2027-12-15	ORANGE_BOOK U-1668	N	N	U English description not available.	—	2027-12-15	—
8722684	2031-06-30	DS/DP —	—	—	—	—	—	—
8722684	2031-12-30	— —	—	—	—	—	2031-12-30	—
8722684	2031-12-30	ORANGE_BOOK —	N	N	DP English description not available.	—	2031-12-30	—
9278096	2032-03-21	U U-2436	—	—	—	—	—	—
9278096	2032-09-21	— —	—	—	—	—	2032-09-21	—
9278096	2032-09-21	ORANGE_BOOK U-2436	N	N	U English description not available.	—	2032-09-21	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
NCE	2013-09-30	2018-09-30	English description not available.	Y	Y	—		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	—		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	—		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	—		Source
M-232	—	2026-08-23		—	—	—	—	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	—		Source
PED	—	2027-02-23		—	—	—	—	Source
PED	2026-08-23	2027-02-23	English description not available.	N	N	—		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 (17)

Type	Date	Role	Basis	Source
PATENT	2026-12-17	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2027-12-15	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2027-12-15	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2027-12-15	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2027-12-15	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2027-12-15	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2027-12-15	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2027-12-15	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2031-12-30	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2032-09-21	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_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	—	HISTORICAL_CONTEXT	INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	UPDATE TO THE PRESCRIBING INFORMATION FOR VORTIOXETINE ON TREATMENT-EMERGENT SEXUAL DYSFUNCTION COMPARING VORTIOXETINE AND SSRIS	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_STATUS	—	TERMINAL_STATUS	FDA DISC action month 2017-03; never marketed; Final exact ANDA link not identified; not certified generic absence.	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.