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 three 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

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.

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	204447-004	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	204447-001	Sep 30, 2013		RX	Yes	No					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	204447-003	Sep 30, 2013
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013

International Patents for vortioxetine hydrobromide

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008113359
Iceland	2732
Spain	2379200
Denmark	2044043

Supplementary Protection Certificates for vortioxetine hydrobromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1436271	PA2014013	Lithuania		PRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271	C20140012 00108	Estonia		PRODUCT NAME: VORTIOKSETIIN;REG NO/DATE: K(2013)9715 LOPLIK 20.12.2013
1436271	C300652	Netherlands		PRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
1436271	1490023-7	Sweden		PRODUCT NAME: VORTIOXETINE ELLER ETT FARMACEUTISKT GODTAGBART SYRAADDITIONSSALT DAERAV; REG. NO/DATE: EU/1/13/891 20131218

Market Dynamics and Financial Trajectory for Vortioxetine Hydrobromide

Last updated: March 4, 2026

What is the current market status of vortioxetine hydrobromide?

Vortioxetine hydrobromide, marketed as Brintellix and Trintellix, is an antidepressant approved for treating major depressive disorder (MDD). Since its FDA approval in 2013, the drug has established a presence primarily within North American and European markets.

Market Penetration and Adoption

• Global sales reached approximately $842 million in 2022, with the U.S. constituting nearly 65% of this figure.
• The drug's market share in the antidepressant category was estimated at 2.8% in 2022, ranked behind SSRIs and SNRIs.
• The European market accounts for about 25%, driven by regulatory approval in key countries such as the UK, Germany, and France.

Competitive Landscape

• Vortioxetine faces competition from established antidepressants: SSRIs (e.g., sertraline, fluoxetine), SNRIs (e.g., venlafaxine), and newer agents like esketamine.
• Its differentiated mechanism—multiple receptor activity—posits it as a treatment for patients with inadequate response to SSRIs/SNRIs.
• Market penetration remains limited by prescriber familiarity and positioning as a second-line therapy.

What are the key market drivers and constraints?

Drivers

• Rising prevalence of MDD: The WHO estimates over 280 million global cases.
• Need for novel treatments: Vortioxetine's cognitive benefits position it favorably for patients with residual symptoms.
• Expanding indications: Emerging research suggests potential for bipolar disorder and generalized anxiety disorder.

Constraints

• Pricing pressures: Brintellix's premium pricing (~$430/month in the U.S.) limits adoption.
• Generic competition: Patent expiry in 2027 could lead to generics, pressuring margins.
• Prescriber inertia: Existing familiarity with SSRIs/SNRIs diminishes immediate uptake.

How does the pipeline impact future revenue projections?

Several late-stage candidates aim to capitalize on vortioxetine's mechanism or position it in wider neuropsychiatric treatment. These include:

• Generic versions in 2027, likely reducing price substantially.
• Combination therapies for complex depression cases.
• Investigational drugs targeting cognitive deficits may extend overall market size.

What are the financial forecasts?

Revenue projections

• Analysts estimate global sales will reach approximately $1.2 billion by 2026, driven by increasing awareness and expanded indications.
• Post-patent expiry, sales could decline 30-50%, pending generic entry.

R&D and regulatory costs

• Development costs for marketing authorization in new indications range from $50 million to $100 million.
• No major ongoing late-stage trials as of 2023,; future pipeline investments remain speculative.

Market exit strategies

• Licensing deals with generic manufacturers are anticipated post-2027 patent expiry.
• Potential for mergers or acquisition by larger pharma firms aiming to expand psychiatric portfolio.

What are the key risks and opportunities?

Risks

• Market share erosion post-generic entry.
• Lower-than-expected adoption due to prescriber bias or insurance coverage issues.
• Regulatory delays in expanding approved indications.

Opportunities

• Development of formulations with improved side effect profiles.
• Combination regimens for resistant depression cases.
• Expansion into emerging markets with rising mental health awareness.

Key Takeaways

• Vortioxetine hydrobromide's sales peaked at $842 million in 2022, with growth expected to stabilize or decline post-2027 due to patent expiration.
• The drug's market faces competitive, pricing, and prescriber familiarity challenges but benefits from its unique mechanism and emerging indications.
• Future revenue relies on patent protection, pipeline expansion, and market penetration strategies amidst increasing competition and pricing pressures.

FAQs

1. When will vortioxetine hydrobromide face generic competition?
Patent expiry is scheduled for 2027, after which generics are expected to enter markets, significantly reducing price premiums.

2. What are the primary markets for vortioxetine?
North America and Europe dominate, representing roughly 90% of global sales, with emerging markets gradually adopting newer antidepressants.

3. How does vortioxetine compare to SSRIs in efficacy?
Clinical studies indicate similar efficacy to SSRIs in treating depression but with potential cognitive benefits and a different side effect profile.

4. Are there ongoing clinical trials for new indications?
As of 2023, no significant late-stage trials are ongoing, though exploratory studies suggest possible uses in cognitive impairment and bipolar disorder.

5. What strategies could sustain vortioxetine's market share post-patent expiry?
Strategies include line extension, combination therapies, cost reductions, and expanding indications to broader patient populations.

References

1. IQVIA Pharmaceuticals. (2023). Market Analysis Report: Antidepressants.
2. World Health Organization. (2022). Depression Fact Sheet.
3. U.S. Food and Drug Administration. (2013). Approval Letter for Vortioxetine.
4. EvaluatePharma. (2022). Market Forecast: Antidepressants.
5. IMS Health. (2022). Global Prescription Trends.