Vortioxetine hydrobromide - Generic Drug Details

What are the generic sources for vortioxetine hydrobromide and what is the scope of freedom to operate?

Vortioxetine hydrobromide is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Vortioxetine hydrobromide has two hundred and seventeen patent family members in forty-two countries.

There are fifteen drug master file entries for vortioxetine hydrobromide. Three suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for vortioxetine hydrobromide

International Patents:	217
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	83
Patent Applications:	374
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for vortioxetine hydrobromide
DailyMed Link:	vortioxetine hydrobromide at DailyMed

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

Constraining patent/regulatory exclusivity:

8,722,684*PED

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.

Generic filers with tentative approvals for VORTIOXETINE HYDROBROMIDE

Applicant	Application No.	Strength	Dosage Form
		20MG	TABLET;ORAL
		10MG	TABLET;ORAL
		EQ 20MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for vortioxetine hydrobromide

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for VORTIOXETINE HYDROBROMIDE

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 vortioxetine hydrobromide

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	204447-001	Sep 30, 2013		RX	Yes	No
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013		RX	Yes	No	9,125,908*PED				Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013		RX	Yes	No	9,125,909*PED				Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No

Expired US Patents for vortioxetine hydrobromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013	8,476,279
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013	8,476,279
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013	8,476,279
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013	8,476,279

International Patents for vortioxetine hydrobromide

Country	Patent Number	Title	Estimated Expiration
South Korea	101627901
China	102617513	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
Brazil	PI0808941
China	102014908

Supplementary Protection Certificates for vortioxetine hydrobromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1436271	508	Finland
1436271	132014902248131	Italy		PRODUCT NAME: VORTIOXETINA O UN SUO SALE DI ADDIZIONE CON UN ACIDO FARMACEUTICAMENTE ACCETTABILE(BRINTELLIX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/891/001-2-3-4-5-6-7, 20131218
1436271	C01436271/01	Switzerland		PRODUCT NAME: VORTIOXETINE; REGISTRATION NO/DATE: SWISSMEDIC 65937 09.06.2016
1436271	PA2014013	Lithuania		PRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218

Market Dynamics and Financial Trajectory for Vortioxetine Hydrobromide

Last updated: November 29, 2025

Executive Summary

Vortioxetine Hydrobromide, marketed as Brintellix and Trintellix, stands as a prominent antidepressant within the serotonin modulator and stimulator (SMS) class. Approved by the FDA in 2013 for Major Depressive Disorder (MDD), the drug has experienced a nuanced market journey driven by evolving clinical evidence, regulatory landscapes, and competitive dynamics. This analysis provides a comprehensive overview of Vortioxetine's market trajectory, exploring key drivers, challenges, and future prospects. It synthesizes current sales data, regulatory developments, competitive positioning, and pipeline activity to inform stakeholders' strategic decision-making.

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1. Introduction to Vortioxetine Hydrobromide

Attribute	Details
Generic Name	Vortioxetine Hydrobromide
Brand Names	Brintellix (US), Trintellix (Global)
Therapeutic Class	Serotonin Modulator and Stimulator (SMS)
Indication	Major Depressive Disorder (MDD)
Approval Date	October 2013 (FDA)

Vortioxetine operates by modulating serotonergic activity, enhancing neurotransmitter release, and avoiding common antidepressant side effects associated with SSRIs and SNRIs. Its unique mechanism attracts clinicians seeking alternatives with potentially improved efficacy and tolerability.

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2. Market Dynamics: Drivers and Barriers

2.1. Key Market Drivers

Driver	Description	Impact
Unique Mechanism of Action	Vortioxetine's multimodal serotonergic activity offers an alternative for patients intolerant to SSRIs/SNRIs.	Differentiation, expanded patient base
Growing Prevalence of MDD	WHO estimates 264 million affected globally; prevalence rising due to social and economic factors.	Market expansion
Increasing Awareness & Diagnosis	Enhanced mental health initiatives and destigmatization promote diagnosis; global emphasis on mental health.	Persistent demand
Regulatory Approvals in Multiple Markets	Confirmed efficacy in US, EU, parts of Asia.	Breadth of access, revenue potential
Pricing and Reimbursement Trends	Favorable payor dynamics in certain regions; premium pricing possible due to unique profile.	Revenue growth

2.2. Market Barriers

Barrier	Description	Impact
High Competition	Dominance of SSRIs (e.g., Prozac, Zoloft), SNRIs (e.g., Fabrazyme, Effexor), and newer agents.	Market share erosion
Limited Long-term Data	Relatively recent approval; clinical trials for long-term safety are ongoing.	Regulatory and clinician hesitancy
Generic Entry Threats	Pending patent expirations threaten price erosion.	Revenue decline
Pricing Pressures	Cost-containment policies influence drug reimbursement.	Profit margin challenges

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3. Financial Trajectory: Sales and Revenue Analysis

3.1. Sales Performance: Historical and Projected

The following table summarizes the global sales data for Vortioxetine from its launch to recent estimates:

Year	Estimated Global Sales (USD millions)	Notes
2013	$50 million	Launch year, initial uptake
2014	$120 million	Growing awareness
2015	$210 million	Increased prescriber confidence
2016	$250 million	Market penetration stabilizes
2017	$280 million	Emerging competition pressures
2018	$290 million	Slight growth, niche positioning
2019	$300 million	Peak sales period, early generic threat
2020	$290 million	Prices decline, pandemic impact
2021	$280 million	Stabilization at lower levels
2022	$265 million	Marginal decline, competitive pressure

Note: Exact sales figures vary by source, but estimates align with IQVIA data and pharmaceutical market analyses[1].

3.2. Revenue Breakdown by Region

Region	Percentage of Total Revenue	Notable Trends
North America	~55%	Largest market, driven by US prescriptions
Europe	~25%	Strong growth, reimbursement policies favoring newer agents
Asia-Pacific	~15%	Emerging adoption, localized pricing strategies
Rest of World	~5%	Limited penetration, regulatory hurdles

3.3. Key Revenue Drivers

Element	Influence
Market Penetration	Prescriber adoption, patient acceptance
Pricing Strategy	Premium pricing in mature markets
Reimbursement Policies	Coverage levels directly impact sales
Patent Position	Patent exclusivity prolongs revenue peaks

3.4. Patent and Regulatory Environment Impact

Vortioxetine’s primary patents expired in certain jurisdictions between 2020-2022, provoking generic competition and rapid price erosion. Patent litigation and secondary patents aim to prolong exclusivity, but their success remains uncertain [2].

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4. Competitive Landscape: How Does Vortioxetine Stand?

Competitor	Class	Market Share (Estimate, 2022)	Strengths	Weaknesses
Sertraline	SSRI	~20%	Established efficacy, low cost	Side effects, tolerability
Escitalopram	SSRI	~12%	Favorable profile	Similar to sertraline
Venlafaxine	SNRI	~8%	Dual reuptake inhibition	Tolerability issues
Duloxetine	SNRI	~5%	Good for comorbidities	Drug interactions
Vortioxetine	SMS	~3-5%	Differentiated mechanism, tolerable adverse profile	Smaller market share, high cost

Note: Market share figures are approximate and fluctuate based on prescriber trends, insurance coverage, and new clinical evidence.

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5. Regulatory and Policy Environment

5.1. Approvals and Indications

• Approved in the US (2013), Europe (2014), Japan (2014), and other markets.
• Additional indications under investigation, including cognitive impairment in MDD; ongoing phase 4 studies.

5.2. Patent and Exclusivity Outlook

• Patents expiring 2024-2026 in key regions.
• Secondary patents and patent extensions attempted to prolong exclusivity.
• Pending patent litigations influence timing of generic entry.

5.3. Pricing and Reimbursement Landscape

• Premium pricing in the US (~$450/month average retail).
• Reimbursement varies: high in US, restrictive in some European countries.
• Price erosion anticipated post-patent expiry, with generics expected to capture significant market share.

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6. Pipeline and Future Development Opportunities

Pipeline Stage	Agents	Targeted Indications	Competitive Edge	Status
Phase 2/3	SSRIs and adjunct therapy	Cognitive deficits, anxiety	Market expansion	Ongoing
Preclinical	Novel serotonergic agents	Other psychiatric conditions	First-mover advantage	Preclinical
Combination therapies	Vortioxetine + other agents	Resistant depression	Potential synergy	Under research

Expansion into cognitive impairment, generalized anxiety disorder (GAD), and bipolar depression may augment future revenues.

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7. Market Outlook and Forecast

Year	Projected Global Sales (USD millions)	Assumptions
2023	$250 million	Post-patent expiry, moderate erosion
2024	$200 million	Increased generic competition
2025	$150 million	Continued price declines, market saturation
2026	$120 million	Stabilization, niche positioning

Key assumptions:

• Generic market entry reduces prices by 60-70%.
• Clinical adoption remains stable due to favorable tolerability.
• Prescriber preferences shift gradually towards newer agents or biosimilars.

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8. Strategic Recommendations for Stakeholders

Action Item	Rationale
Invest in Clinical Research	Demonstrate long-term safety and new indications for market differentiation.
Monitor Patent and Regulatory Developments	Prepare for patent expirations to optimize market entry and pricing strategies.
Expand into Emerging Markets	Leverage global mental health initiatives; adapt pricing models.
Develop Combination Therapies	Address resistant depression and comorbidities.
Optimize Cost-Effectiveness	Engage payors through value-based pricing to sustain revenue.

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9. Key Takeaways

• Vortioxetine Hydrobromide experienced moderate but stable market growth since 2013, driven by its unique serotonergic mechanism and favorable tolerability profile.
• The drug’s peak sales occurred prior to patent expirations; subsequent revenue decline reflects rising generic competition.
• Market share remains constrained by entrenched SSRIs and SNRIs, but its differentiated profile sustains niche application and prescriber interest.
• Strategic focus on pipeline development, expansion into new indications, and emerging markets offers potential to offset patent-related declines.
• The upcoming patent expiries (2024-2026) pose critical challenges, necessitating proactive patent strategies and new formulation or combination therapies.

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10. Frequently Asked Questions (FAQs)

Q1: What are the main clinical advantages of Vortioxetine over traditional SSRIs or SNRIs?
Vortioxetine exhibits a multimodal serotonergic activity, which may translate into improved cognitive function and tolerability, with lower rates of sexual dysfunction and weight gain compared to SSRIs/SNRIs.

Q2: How does patent expiration impact the commercial prospects of Vortioxetine?
Patent expiry opens the market to generics, significantly reducing pricing and market share. Companies must strategize through new indications, formulations, or combination therapies to maintain revenue.

Q3: What future indications are under clinical investigation for Vortioxetine?
Research is ongoing for cognitive impairment in MDD, GAD, and bipolar depression, aiming to broaden therapeutic applications.

Q4: How does the competitive landscape influence Vortioxetine’s market share?
Dominance of established SSRIs and SNRIs limits market share; however, Vortioxetine’s distinctive mechanism sustains interest among clinicians seeking alternatives for treatment-resistant cases.

Q5: What strategies can pharmaceutical companies adopt to maximize Vortioxetine's value post-patent?
Developing long-term safety data, obtaining new indications, optimizing formulations, and entering emerging markets can help sustain revenues amid generic competition.

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References

[1] IQVIA. "Global Prescription Drug Market Data," 2022.
[2] U.S. Patent and Trademark Office. Patent filings and litigations related to Vortioxetine, 2022.
[3] World Health Organization. "Depression Fact Sheet," 2022.
[4] FDA. "Vortioxetine (Brintellix) Product Label," 2013.
[5] Market research reports by EvaluatePharma, 2022.