Vortioxetine Hydrobromide

Treats major depressive disorder (MDD). Sold as Trintellix. Every FDA application for this active ingredient: 1 branded and 3 generic.

As of Nov 15, 2026, FDA lists 4 applications for Vortioxetine Hydrobromide (sold as Trintellix), first approved Sep 30, 2013, with 6 new uses approved and 0 published complete response letters.

First approved: Sep 30, 2013
Applications: 4
New uses approved: 6
Complete response letters: 0
Medicare spending, 2025: $396M
First approved in the EU: Dec 18, 2013
First approved in Japan: Sep 20, 2019

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Trintellix	Part D	$396M	+1%	97,054

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

TRINTELLIX 10 MG TABLET: $17.20 per unitBrand · +5% in a year
TRINTELLIX 20 MG TABLET: $17.20 per unitBrand · +5% in a year
TRINTELLIX 5 MG TABLET: $17.20 per unitBrand · +5% in a year

Approvals in the EU (EMA)

First approved in the EU 3 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Brintellix, new substanceH. Lundbeck A/S · Dec 18, 2013

Approvals in Japan (PMDA)

First approved in Japan 72 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Trintellix, new ingredientDrugs with a new active ingredient indicated for the treatment of depression. · Takeda Pharmaceutical Company Limited · Sep 20, 2019

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Compare the Efficacy and Safety of KH607 Tablets Versus Vortioxetine Hydrobromide Tablets in Adult Patients With Major Depressive DisorderMajor Depressive Disorder (MDD) · Chengdu Kanghong Pharmaceutical Group Co., Ltd.	Phase 3	Not yet recruiting	Aug 3, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 30, 2013	TrintellixNDA 204447 · New molecular entity	Takeda Pharms USA	20	Marketed
—	Vortioxetine HydrobromideANDA 211101	Msn Laboratories Private Ltd	0	Discontinued
—	Vortioxetine HydrobromideANDA 211130	Apotex Inc	0	Discontinued
—	Vortioxetine HydrobromideANDA 211146	Zydus Pharms	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA