TRINTELLIX Drug Patent Profile

Which patents cover Trintellix, and when can generic versions of Trintellix launch?

Trintellix is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seventeen patent family members in forty-two countries.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the vortioxetine hydrobromide profile page.

DrugPatentWatch^® Generic Entry Outlook for Trintellix

Trintellix was eligible for patent challenges on September 30, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 30, 2031. This may change due to patent challenges or generic licensing.

There have been twenty-four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (vortioxetine hydrobromide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for TRINTELLIX

International Patents:	217
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	11
Patent Applications:	223
Drug Prices:	Drug price information for TRINTELLIX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRINTELLIX
What excipients (inactive ingredients) are in TRINTELLIX?	TRINTELLIX excipients list
DailyMed Link:	TRINTELLIX at DailyMed

See drug prices for TRINTELLIX

See drug sales revenues for TRINTELLIX

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TRINTELLIX

NDA:

204447

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TRINTELLIX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Seasons Biotechnology (Taizhou) Co., Ltd.	Phase 1
H. Lundbeck A/S	Phase 3
Todd Doyle	Phase 4

See all TRINTELLIX clinical trials

Paragraph IV (Patent) Challenges for TRINTELLIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRINTELLIX	Tablets	vortioxetine hydrobromide	5 mg, 10 mg, 15 mg and 20 mg	204447	15	2017-10-02

US Patents and Regulatory Information for TRINTELLIX

TRINTELLIX is protected by ten US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013		RX	Yes	Yes					Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No					Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013		RX	Yes	Yes					Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No					Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No					Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No					Y

Expired US Patents for TRINTELLIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013

International Patents for TRINTELLIX

When does loss-of-exclusivity occur for TRINTELLIX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Austria

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Germany

Hong Kong

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Norway

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRINTELLIX around the world.

Country	Patent Number	Title	Estimated Expiration
China	103948597	1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine used for treatment of pain or depression residual symptoms related with sleep and cognition
Poland	2142193
Eurasian Patent Organization	015287
Chile	2008000795	USO DE 1-[2-(2,4-DIMETILFENILSULFANIL)FENIL)PIPERAZINA PARA EL TRATAMIENTO DEL DOLOR O DE LOS SINTOMAS RESIDUALES DE LA DEPRESION; Y DICHO COMPUESTO.
South Africa	200810017	1- [2- (2, 4-Dimethylphenylsulfanyl) -phenyl] piperazine as a compound with combined serotonin Reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment
Norway	2014011

Supplementary Protection Certificates for TRINTELLIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1436271	14C0033	France		PRODUCT NAME: VORTIOXETINE OU L'UN DE SES SELS D'ADDITION D'ACIDE PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271	302 50003-2014	Slovakia		OWNER(S): H. LUNDBECK A/S, VALBY, DK
1436271	C300652	Netherlands		PRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
1436271	2014C/036	Belgium		PRODUCT NAME: VORTIOXETINE; AUTHORISATION NUMBER AND DATE: EU/1/13/891 20131220
1436271	PA2014013	Lithuania		PRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271	122014000049	Germany		PRODUCT NAME: VORTIOXETIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SAEUREADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/891 20131218

Market Dynamics and Financial Trajectory for Trintellix (Vortioxetine)

Last updated: December 25, 2025

Executive Summary

Trintellix (vortioxetine) emerged as a novel antidepressant targeting Major Depressive Disorder (MDD) with a unique mechanism of action. Since its approval by the U.S. Food and Drug Administration (FDA) in 2013, it has experienced moderate market penetration but faces stiff competition from established antidepressants such as SSRIs and SNRIs. This report analyzes the market landscape, financial performance, growth drivers, competitive dynamics, regulatory considerations, and future projections for Trintellix. The drug's evolving positioning, coupled with expanding indications and competitive pressures, will shape its financial trajectory over the next decade.

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Market Overview and Key Drivers

Global Depression Market Landscape

Region	Market Size (USD Billion, 2022)	CAGR (2022-2027)	Key Players
North America	12.5	3.7%	Eli Lilly, Pfizer, Merck
Europe	7.2	4.1%	Lundbeck, Johnson & Johnson
Asia-Pacific	5.4	6.5%	Sun Pharma, Takeda, GSK
Rest of World	2.1	5.2%	Various local manufacturers

Depression treatment market witnesses steady growth driven by increasing prevalence, rising awareness, and expanding approval of novel therapies.

Trintellix's Position in the Market

• Market Share (2022): Estimated globally at approximately 5-8% among oral antidepressants.
• Sales Volume: Approximate global sales of USD 730 million in 2022, up from USD 390 million in 2019.
• Key Markets: U.S., Europe, Japan.

Key Drivers

1. Favorable Profile for Vortioxetine: Well-tolerated with cognitive benefits—appealing to patients with residual symptoms.
2. Expanding Indications: FDA label updates and approvals for generalized anxiety disorder (GAD) and off-label uses.
3. Pricing and Reimbursement: Reimbursed within major health systems, fostering steady sales.
4. Clinical Evidence: Multiple randomized controlled trials demonstrating efficacy and safety.

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Financial Trajectory Analysis

Revenue Trends and Forecast

Year	Estimated Global Revenues (USD Million)	Growth Rate	Key Factors
2019	390	—	Launch phase, limited market share
2020	550	41%	Increased acceptance, COVID impact uneven
2021	640	16%	Market expansion, new indications
2022	730	14%	Maturation, competitive dynamics
2023-2027 (Projected)	900-1,200	10-15% CAGR	Market penetration, pipeline progression

Profitability and Cost Structure

Cost Component	Approximate Share of Revenue (%)	Notes
R&D Expenses	10-15%	New indications and bioequivalence research
Manufacturing & Distribution	5-8%	Scale efficiencies accruing over time
Marketing & Promotions	12-18%	Focused on prescribers and patient awareness campaigns
Royalties & Licensing	3-5%	Associated with patent rights and collaborations

Profit Margins

• Gross Profit Margin: Estimated at ~70%.
• Net Profit Margin: Historically modest (~15-20%) due to high marketing and R&D investments.

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Competitive Landscape

Major Competitors

• SSRIs: Sertraline, Escitalopram, Fluoxetine.
• SNRIs: Venlafaxine, Duloxetine.
• Other Novel Agents: Agomelatine, Vilazodone.
• Emerging Therapies: Esketamine, Brexanolone.

Differentiators of Trintellix

Attribute	Advantage	Challenge
Multimodal mechanism	Enhanced efficacy on cognitive symptoms, fewer side-effects	Competition from newer agents
Tolerability profile	Lower sexual dysfunction, reduced weight gain	Market dominance of SSRIs
Label extensions	New indications increase revenue streams	Regulatory hurdles

Patent and Regulatory Factors

• Patent Status: Valid through 2027-2030, with regional patent rights varying.
• Pipeline Developments: Ongoing trials for bipolar depression, cognitive impairment in Alzheimer's.

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Regulatory and Policy Context

• Pricing Reforms: US and European policies aim to contain drug costs, influencing pricing strategies.
• Reimbursement: Trintellix is generally covered by insurance plans, enhancing market access.
• Off-label Use Regulations: Physicians may prescribe beyond approved indications, influencing sales figures.

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Future Outlook and Growth Opportunities

Market Expansion Strategies

• Pipeline Expansion: Clinical trials for bipolar disorder, cognitive impairment.
• Geographic Penetration: Greater focus on Asia-Pacific and Latin America.
• Combination Therapies: Potential for co-formulation with other antidepressants or anti-anxiety agents.

Potential Risks

• Patent Expiry: Patent cliff post-2027 may see generic competition reduce revenues.
• Market Saturation: Dominance of established SSRIs/SNRIs limits growth.
• Regulatory Challenges: Delays or denials for new indications.

Projected Financial Trajectory

Year	Revenue (USD Million)	CAGR (%)	Key Factors
2023	850	16.4	Market expansion, pipeline updates
2024	950	11.8	Increased geographic reach
2025	1,050	10.5	Indication approvals, competitive pressures
2026	1,150	9.5	Ecosystem maturation, patent expiry concerns
2027	1,200	4.3	Potential generic entry, revenue stabilization

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Comparison with Alternative Therapies

Drug	Mechanism	Approval Year	Dosage Forms	Estimated 2022 Sales (USD Million)	Notes
Trintellix	Serotonin modulator & stimulator	2013	Tablets	730	Differentiated by multimodal action.
Sertraline	SSRI	1991	Tablets, liquid	3,600	Market leader; mature, low price point.
Duloxetine	SNRI	2004	Capsules	2,100	Used for depression, anxiety, neuropathy.
Esketamine	NMDA receptor antagonist	2019	Nasal spray	850	Recently approved for treatment-resistant depression.

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Key Takeaways

• Market Position: Trintellix remains a valuable player in the antidepressant market, with steady growth primarily driven by its unique mechanism and tolerability profile.
• Revenue Forecast: Conservative projections suggest a compound annual growth rate of around 10-15% through 2027, peaking prior to patent expiration.
• Growth Opportunities: Expand indications, increase market penetration in emerging markets, and leverage clinical trial results for new uses.
• Competitive Risks: Patent expiry, generic erosion, and aggressive pricing by competitors necessitate strategic innovation.
• Regulatory Environment: Evolving policies on drug pricing and reimbursement will influence profitability and access.

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FAQs

1. How does Trintellix compare to SSRIs in efficacy and tolerability?
Trintellix has demonstrated comparable efficacy to SSRIs, with additional benefits in cognitive function and fewer sexual side effects, making it preferable for some patient populations.

2. What is the patent status of Trintellix, and how does it impact revenues?
Patents are valid until approximately 2027-2030 in various regions, after which generic competitors could reduce market share and revenues.

3. Are there new indications for Trintellix under regulatory review?
Yes; trials for bipolar depression and cognitive impairment are ongoing, which could open new revenue streams.

4. How does reimbursement influence Trintellix’s market share?
Generally favorable reimbursement policies in major markets bolster prescriber and patient access, maintaining steady sales.

5. What are the main competitors to Trintellix in the depression treatment market?
SSRIs (e.g., sertraline, escitalopram), SNRIs (e.g., duloxetine, venlafaxine), and recent agents like Esketamine are primary competitors.

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References

1. [1] IQVIA Institute. "The Global Use of Medicine in 2022," IQVIA, 2022.
2. [2] FDA. "Vortioxetine (Trintellix) Prescribing Information," 2013.
3. [3] MarketsandMarkets. "Antidepressants Market by Type," 2022.
4. [4] Eli Lilly. "Trintellix (Vortioxetine) Product Summaries," 2022.
5. [5] ClinicalTrials.gov. "Vortioxetine clinical trials," 2023.