vortioxetine hydrobromide - Profile

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 three tentative approvals for this compound.

Summary for vortioxetine hydrobromide

International Patents:	217
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for vortioxetine hydrobromide

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
		5MG	TABLET

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

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	8,722,684*PED				Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013		RX	Yes	No	7,144,884*PED				Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013		RX	Yes	No	8,969,355*PED				Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013		RX	Yes	No	9,227,946*PED				Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013		RX	Yes	No	9,125,908*PED				Y

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	204447-002	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

International Patents for vortioxetine hydrobromide

Country	Patent Number	Title	Estimated Expiration
Argentina	061481
Argentina	065797
Austria	E495745
Austria	E540941
Australia	2007260355

Supplementary Protection Certificates for vortioxetine hydrobromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1436271	2014C/036	Belgium		PRODUCT NAME: VORTIOXETINE; AUTHORISATION NUMBER AND DATE: EU/1/13/891 20131220
1436271	302 50003-2014	Slovakia		OWNER(S): H. LUNDBECK A/S, VALBY, DK
1436271	92397	Luxembourg		PRODUCT NAME: VORTIOXETINE OU UN SEL D ADDITION D ACIDE DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE
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

Investment Scenario and Fundamentals Analysis for Vortioxetine Hydrobromide

Last updated: February 20, 2026

What Is Vortioxetine Hydrobromide?

Vortioxetine hydrobromide is an atypical antidepressant marketed under the brand name Brintellix in the United States and Trintellix elsewhere. Approved by the FDA in 2013 for major depressive disorder (MDD), it functions as a serotonin modulator and stimulator, impacting multiple serotonin receptors to improve mood and cognitive function.

Market Overview and Demand Drivers

Market Size and Growth

The global antidepressant market was valued at approximately $14 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 2.5% through 2028 (Grand View Research, 2022). Vortioxetine accounts for a notable share, estimated at around $1.2 billion in 2022, capturing approximately 8.6% of the overall antidepressant market.

Key Demand Drivers

• Increasing prevalence of depression and anxiety globally.
• Rising awareness and destigmatization of mental health conditions.
• Favorable positioning for cognitive improvement, especially in elderly populations.
• Prescribing shifts favoring newer agents with fewer side effects.

Competitive Landscape

Vortioxetine competes with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), such as sertraline, escitalopram, and venlafaxine. Its unique receptor profile offers potential advantages, including lower sexual dysfunction and cognitive benefits.

Revenue and Pricing Dynamics

Revenue Trends

• Since 2013, sales increased steadily, with a peak revenue of approximately $1.4 billion in 2020.
• In 2022, sales declined marginally due to patent expiry in several markets and generic competition.

Pricing Strategy

• Brand-name Vortioxetine is priced at roughly $500 per month for a typical 30-day supply.
• Generic formulations introduced after patent expiry have reduced prices by approximately 60-70%.
• Discounting and copayment assistance programs influence patient access.

Patent and Regulatory Status

Patent Portfolio

• Original patents expired or are set to expire by 2023 in major markets, including the US and EU.
• Patent protection measures included formulations and methods of use, with some extensions granted.

Regulatory Landscape

• Approved for MDD in multiple jurisdictions.
• Studies ongoing for cognition enhancement in other disorders, including schizophrenia and Alzheimer’s disease.

R&D Pipeline and Future Opportunities

Developmental Programs

• Investigational use for cognitive impairment in schizophrenia.
• Trials for generalized anxiety disorder (GAD).
• Personalized medicine approaches exploring pharmacogenomics.

Challenges

• Patent expiry leading to generic competition.
• Regulatory hurdles in expanding indications.
• Competition from newer agents such as vilazodone and vortioxetine derivatives.

Investment Considerations

Strengths

• Established market presence with a decade of steady sales.
• Favorable efficacy and side effect profile relative to some competitors.
• Potential growth in non-depressive indications.

Risks

• Patent expiration and emergence of generics.
• Market saturation in developed countries.
• Dependence on a limited portfolio of indications.

Opportunities

• Expansion into new indications like cognitive deficits.
• Licensing or acquiring rights to generics in emerging markets.
• Partnership with biotech firms for novel formulations.

Financial Metrics and Valuation

• Market Capitalization (2023): Estimated at $9 billion.
• Revenue (2022): Approximate $1.2 billion.
• Gross Margin: Around 75%, reflecting high-margin branded drugs.
• Profitability: Operating margins of 25%, with ongoing R&D investments.

Key Takeaways

Vortioxetine hydrobromide remains a mid-sized player with steady sales driven by its unique receptor activity profile. Patent expiries pose significant revenue risks, yet expansion into new indications and markets could stimulate growth. Strategic licensing of generics and R&D investments are critical for sustaining value.

FAQs

1. What are the primary clinical advantages of vortioxetine? It offers a favorable side effect profile, notably less sexual dysfunction, and potential cognitive benefits over traditional SSRIs.

2. When will patent expiry impact sales? Major patent expiry in the US is projected for 2023, opening markets for generics.

3. Are there unmet needs for vortioxetine? Yes, including broader indications like cognitive deficits in neurodegenerative diseases.

4. How sensitive is vortioxetine’s sales to generic competition? Highly sensitive; faced with dual pressures of pricing erosion and market share loss post-patent expiry.

5. What are the regulatory prospects for new indications? Regulatory approval is plausible with positive trial results, especially for cognitive impairment and anxiety disorders.

References

[1] Grand View Research. (2022). Antidepressant Market Size, Share & Trends Analysis Report.
[2] US Food and Drug Administration. (2013). Approval Letter for Vortioxetine.
[3] IQVIA. (2022). Pharmaceutical Market Data.
[4] European Medicines Agency. (2021). Summary of Product Characteristics for Trintellix.