trintellix Drug Patent Profile

When do Trintellix patents expire, and what generic alternatives are available?

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
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013		RX	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	204447-003	Sep 30, 2013
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	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
Hungary	S1400012
Taiwan	I443091
South Korea	100783346
Slovenia	2219647
Hong Kong	1134483
Croatia	P20120173
Montenegro	P6508

Supplementary Protection Certificates for trintellix

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1436271	2014/022	Ireland		PRODUCT NAME: VORTIOXETINE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/891 20131220
1436271	122014000049	Germany		PRODUCT NAME: VORTIOXETIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SAEUREADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/891 20131218
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	C 2014 023	Romania		PRODUCT NAME: VORTIOXETINA SAU O SARE DE ADITIE ACIDA A ACESTEIAACCEPTABILA FARMACEUTIC1-[2-(2,4-DIMETILFENILSULFANIL)FENIL]PIPERAZINA; NATIONAL AUTHORISATION NUMBER: EU/1/13/891; DATE OF NATIONAL AUTHORISATION: 20131218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/891; DATE OF FIRST AUTHORISATION IN EEA: 20131218
1436271	C20140012 00108	Estonia		PRODUCT NAME: VORTIOKSETIIN;REG NO/DATE: K(2013)9715 LOPLIK 20.12.2013
1436271	CR 2014 00030	Denmark		PRODUCT NAME: VORTIOXETIN ELLER FARMACEUTISK ACCEPTABLE SYREADDITIONSSALTE DERAF, HERUNDER VORTIOXETINHYDROBROMID; REG. NO/DATE: EU/1/13/891 20131218
1436271	C300652	Netherlands		PRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218

Market Dynamics and Financial Trajectory for Trintellix

Last updated: July 27, 2025

Introduction

Trintellix (vortioxetine), marketed by Lundbeck and Takeda Pharmaceuticals, represents a significant entrant in the antidepressant landscape. Approved by the U.S. Food and Drug Administration (FDA) in 2013, Trintellix is prescribed primarily for Major Depressive Disorder (MDD). This analysis delineates the market forces influencing Trintellix’s commercial trajectory, the competitive environment, regulatory considerations, and financial prospects shaping its future.

Market Overview and Therapeutic Landscape

Depression Treatment Market

The global depression treatment market has been expanding steadily, driven by rising prevalence rates, increased awareness, and evolving treatment paradigms. The World Health Organization (WHO) estimates over 280 million people globally suffer from depression, representing a substantial patient base [1]. The antidepressant segment accounts for a significant share of this market, with varying drug classes including Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), atypical antidepressants, and novel agents like Trintellix.

Positioning of Trintellix

Unlike traditional antidepressants, Trintellix offers a unique mechanism of action—combining serotonin reuptake inhibition with multimodal activity on serotonergic receptors—potentially contributing to its efficacy and tolerability profile [2]. Its indication for MDD and data supporting cognitive benefits have positioned it as a differentiated product in an increasingly crowded market.

Market Dynamics Influencing Trintellix

Competitive Landscape

Trintellix faces considerable competition from established drugs such as escitalopram, sertraline, and SNRIs like venlafaxine and duloxetine. The market also comprises generic versions of many first-line antidepressants, exerting downward pressure on prices. Notably, the patent expiration wave, particularly for older SSRIs and SNRIs, has led to generic proliferation, challenging branded products like Trintellix.

However, Trintellix's patent exclusivity for certain formulations provides a temporary market advantage, with patent expiry potentially looming within the next few years—possibly around 2025-2026 [3].

Pricing and Reimbursement Dynamics

Pricing strategies significantly impact Trintellix’s market share. Studies indicate that cost considerations influence prescriber preferences, especially when the efficacy differences are marginal across antidepressants. Reimbursement policies, formulary inclusion, and insurance coverage also shape patient access. For instance, in the U.S., Trintellix’s placement on formularies with favorable tier status enhances its utilization, although competition from generics reduces its relative pricing power.

Regulatory and Patent Strategies

Lundbeck and Takeda have pursued various patent protections surrounding formulations, delivery methods, and potential new indications to extend exclusivity. These legal strategies mitigate the risk of early generic entry, allowing additional revenue streams. However, patent challenges and patent cliffs remain critical uncertainties.

Physician and Patient Preferences

Clinician prescribing behaviors pivot on perceived efficacy, tolerability, and patient adherence. Trintellix’s favorable side effect profile (e.g., reduced sexual dysfunction) compared to some SSRIs and SNRIs may foster its adoption, particularly among treatment-resistant populations. Patient demand for medications with improved tolerability sustains its market presence.

Financial Trajectory and Revenue Analysis

Historical Revenue Performance

Since its launch, Trintellix’s revenues have exhibited steady growth, although growth rates have plateaued in recent years due to increasing generic competition and market saturation. In 2021, Lundbeck reported global revenues from Trintellix approximating $240 million, reflecting mature commercialization dynamics [4].

Forecasting Future Revenue Potential

The financial outlook hinges on several factors:

• Patent Protection and Exclusivity: The expiration timeline will dictate revenue trajectory. An imminent patent cliff could precipitate significant revenue declines unless offset by new formulations or indications.
• Market Penetration & Uptake: Expansion into emerging markets offers growth avenues, particularly if healthcare infrastructure improves and prescribing patterns evolve.
• Pipeline Developments: Ongoing research might lead to new indications, such as generalized anxiety disorder or cognitive impairment, diversifying revenue sources.
• Pricing Strategies: Maintaining premium pricing depends on demonstrating superior efficacy/tolerability, influencing margins and profitability.

Impact of Generic Entry

The entry of generic vortioxetine—expected as early as 2025—would substantially reduce Trintellix’s price point, compressing margins and limiting revenue potential unless offset by volumetric expansion or sustained brand loyalty. The duration of market exclusivity will critically determine financial sustainability.

Investment and Acquisition Outlook

The pharmaceutical industry’s consolidation trends —including licensing, partnerships, or potential acquisition—could influence Trintellix’s financial trajectory. Strategic alliances for expanded marketing and distribution are likely to enhance revenue prospects.

Regulatory Environment

Regulatory bodies in the U.S., EU, and emerging markets directly impact market access strategies. FDA’s evolving guidelines on patent protection, biosimilar regulation, and post-marketing commitments shape the competitive landscape. Clarity and stability in regulation foster investor confidence and enable strategic planning.

Conclusion

Trintellix’s market dynamics are characterized by a mature competitive landscape, patent protections, and evolving treatment preferences favoring tolerability and efficacy. While current revenues reflect a stable base, impending patent expirations threaten future financial stability unless countered by pipeline advances or market expansion. Stakeholders must strategically navigate patent management, formulary positioning, and market diversification to optimize the drug’s financial trajectory.

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Key Takeaways

• Market positioning of Trintellix relies on its unique pharmacology and tolerability; however, competition from generics remains a significant challenge.
• Patent expirations within the next few years are expected to exert downward pressure on revenue unless new formulations or indications emerge.
• Pricing strategies and formulary access are critical for sustaining profitability amid increasing generic competition.
• Emerging markets and pipeline development offer growth potential, contingent on regulatory approvals and market penetration strategies.
• Industry consolidation and licensing could bolster Trintellix’s financial prospects through strategic partnerships and expanded indications.

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FAQs

1. When is Trintellix expected to face generic competition?
Patent exclusivity for vortioxetine is anticipated to expire around 2025-2026, opening the door for generic formulations and significant revenue reduction [3].

2. How does Trintellix compare to other antidepressants in efficacy?
Clinical trials suggest comparable efficacy to SSRIs and SNRIs, with some evidence indicating improved cognitive function and tolerability, potentially influencing clinician choice [2].

3. What strategies can Lundbeck and Takeda deploy to sustain revenues post-patent expiration?
Developing new indications, optimizing formulations, enhancing patient adherence programs, and expanding into emerging markets are key strategies.

4. How has the COVID-19 pandemic affected Trintellix’s market performance?
The pandemic disrupted healthcare delivery and outpatient prescriptions temporarily, but remote consultations and increased mental health awareness have sustained demand for antidepressants, including Trintellix.

5. What are the prospects for Trintellix in non-MDD indications?
Ongoing research explores uses in generalized anxiety disorder, cognitive impairment, and other psychiatric conditions, which could diversify revenue streams if successful.

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References

1. WHO. Depression. World Health Organization; 2022.
2. Stahl SA. "Stahl’s Essential Psychopharmacology," 4th Edition. Cambridge University Press; 2014.
3. Lundbeck. Patent and Exclusivity Data. Lundbeck Annual Report 2022.
4. Lundbeck. Financial Reports, 2021.