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 sixteen 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:	216
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:	137
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
		10MG	TABLET;ORAL
		20MG	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	204447-004	Sep 30, 2013		RX	Yes	Yes	7,144,884*PED				Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No	9,125,909*PED				Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013		RX	Yes	No
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No	9,125,910*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	204447-003	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	204447-002	Sep 30, 2013	8,476,279

International Patents for vortioxetine hydrobromide

Country	Patent Number	Title	Estimated Expiration
Australia	2002333220
Japan	3955614
Brazil	PI0713425	composto, composição farmacêutica, método para tratar uma doença, uso de um composto, e processos para a preparação de um composto, e para a fabricação de um composto
Israel	200956	1-[2-(2,4-דימתילפנילסולפניל)-פניל]פיפרזין לטיפול בכאב (1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine for use in the treatment of pain)
Ukraine	97392	1-[2-(2,4-ДИМЕТИЛФЕНИЛСУЛЬФАНИЛ)ФЕНИЛ]ПИПЕРАЗИН КАК СОЕДИНЕНИЕ С КОМБИНИРОВАННОЙ АКТИВНОСТЬЮ В ОТНОШЕНИИ ОБРАТНОГО ЗАХВАТА СЕРОТОНИНА, 5-НТ3 И 5-НТ1A ДЛЯ ЛЕЧЕНИЯ БОЛИ;1-[2-(2,4-ДИМЕТИЛФЕНІЛСУЛЬФАНІЛ)ФЕНІЛ]ПІПЕРАЗИН ЯК СПОЛУКА З КОМБІНОВАНОЮ АКТИВНІСТЮ СТОСОВНО ЗВОРОТНОГО ЗАХОПЛЕННЯ СЕРОТОНІНУ, 5-HT3 ТА 5-HT1A ДЛЯ ЛІКУВАННЯ БОЛЮ (1-[2-(2,4-DIMETHYLPHENYLSULFANYL)-PHENYL]PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HT3 AND 5-HT1A ACTIVITY FOR THE TREATMENT OF PAIN)

Supplementary Protection Certificates for vortioxetine hydrobromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1436271	122014000049	Germany		PRODUCT NAME: VORTIOXETIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SAEUREADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271	CR 2014 00030	Denmark		PRODUCT NAME: VORTIOXETIN ELLER FARMACEUTISK ACCEPTABLE SYREADDITIONSSALTE DERAF, HERUNDER VORTIOXETINHYDROBROMID; REG. NO/DATE: EU/1/13/891 20131218
1436271	508	Finland
1436271	300652	Netherlands		PRODUCT NAME: VORTIOXETINE OF EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
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

Market Dynamics and Financial Trajectory of Vortioxetine Hydrobromide

Introduction to Vortioxetine Hydrobromide

Vortioxetine hydrobromide, marketed under the trademark Brintellix®, is an atypical antidepressant known for its unique multimodal mechanism of action. It acts as a serotonin modulator and stimulator, influencing different serotonin receptors, making it effective in treating both mood-related and cognitive symptoms of depression[2][4].

Market Size and Growth Projections

The vortioxetine hydrobromide market has been experiencing significant growth and is projected to continue this trend. As of 2023, the market size was valued at USD 915.8 million and is expected to reach USD 1.85 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 10.60% from 2024 to 2031[3][4].

Segmentation and Geographic Distribution

The market is segmented based on type (5mg, 10mg, 20mg) and application (antidepressants, anxiolytics), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). North America and Europe currently dominate the market, but emerging economies, particularly in the Asia-Pacific region, are expected to contribute significantly to the market's growth as mental health services expand[1][4].

Drivers of Market Growth

Several factors are driving the growth of the vortioxetine hydrobromide market:

Increasing Demand for Mental Health Treatments

The rising prevalence of depression and other mental health disorders, coupled with growing awareness and reduced stigma around mental health issues, are driving the demand for effective treatments like vortioxetine hydrobromide[4].

Government Support and Public Awareness

Government initiatives and public awareness campaigns aimed at improving mental health care access have boosted the use of medications like vortioxetine hydrobromide. Financial support for mental health facilities and research has also played a crucial role[4].

Advancements in Drug Formulation

Improvements in drug formulation have enhanced the bioavailability and stability of vortioxetine hydrobromide, making it more effective in managing depression symptoms. These advancements have contributed to the drug's growing popularity[4].

Partnerships and Collaborations

Pharmaceutical companies are forming partnerships with research institutions and mental health organizations to advance research and distribution of vortioxetine hydrobromide. These collaborations have facilitated clinical trials and expanded access to the drug[4].

Market Opportunities

Emerging Markets

Emerging economies in Asia-Pacific and Latin America are investing heavily in healthcare advancements, creating substantial opportunities for the growth of the vortioxetine hydrobromide market. As healthcare infrastructure improves in these regions, access to mental health treatments is becoming more widespread[4].

Digital Health Platforms

The rise of digital health platforms has expanded the reach of mental health services, providing more individuals with access to resources and treatments like vortioxetine hydrobromide. This trend is further boosting the market’s potential[4].

Challenges and Restraints

While the market is poised for significant growth, there are several challenges and restraints to consider:

Competition from Other Antidepressants

The antidepressant market is highly competitive, with various drugs available. Vortioxetine hydrobromide must differentiate itself through its unique therapeutic benefits and safety profile to maintain market share[4].

Regulatory Hurdles

Pharmaceutical companies must navigate stringent regulatory requirements to ensure the quality and safety of vortioxetine hydrobromide. Compliance with international standards, such as those set by the ICH guidelines, is crucial[5].

Financial Trajectory

The financial trajectory of the vortioxetine hydrobromide market is promising, with significant growth anticipated over the next few years. Here are some key financial highlights:

• Market Size: The market was valued at USD 915.8 million in 2023 and is projected to reach USD 1.85 billion by 2031[3].
• CAGR: The market is expected to grow at a CAGR of 10.60% from 2024 to 2031[3].
• Investment Opportunities: The rising demand for effective depression treatments and the unique therapeutic benefits of vortioxetine hydrobromide make it a significant investment opportunity for pharmaceutical companies and venture capitalists[4].

Stability and Formulation

The stability and formulation of vortioxetine hydrobromide are critical factors in its market success. The drug is available in various crystalline forms, each with its own characteristics. For instance, the delta crystalline form has high solubility in water, making it more suitable for pharmaceutical formulations. The stability data indicate that the active substance is sufficiently stable under various storage conditions, justifying the proposed retest period[2][5].

Key Takeaways

• The vortioxetine hydrobromide market is expected to grow significantly, driven by increasing demand for mental health treatments and advancements in drug formulation.
• Emerging markets in Asia-Pacific and Latin America offer substantial growth opportunities.
• Government support and public awareness campaigns are boosting the market.
• The drug's unique therapeutic benefits and safety profile are key differentiators in a competitive market.
• Investment in mental health research and partnerships with research institutions are crucial for market growth.

Frequently Asked Questions (FAQs)

Q: What is the primary mechanism of action of vortioxetine hydrobromide? A: Vortioxetine hydrobromide acts as a serotonin modulator and stimulator, influencing different serotonin receptors, including SERT-inhibitor, 5-HT 3 antagonist, and partial 5-HT 1A agonist actions[2].

Q: What are the key drivers of the vortioxetine hydrobromide market growth? A: The key drivers include increasing demand for mental health treatments, government support and public awareness, advancements in drug formulation, and partnerships with research institutions[4].

Q: Which regions are expected to contribute significantly to the market's growth? A: Emerging economies in Asia-Pacific and Latin America are expected to contribute significantly to the market's growth as mental health services expand in these regions[4].

Q: What are the different crystalline forms of vortioxetine hydrobromide, and which is most suitable for pharmaceutical formulations? A: The drug is available in various crystalline forms, including the delta form, which has high solubility in water and is more suitable for pharmaceutical formulations[2].

Q: What is the projected CAGR of the vortioxetine hydrobromide market from 2024 to 2031? A: The market is expected to grow at a CAGR of 10.60% from 2024 to 2031[3].

Sources Cited

1. Market Research Intellect - Global Vortioxetine Hydrobromide Tablets Market Size, Scope And Forecast 2021-2031.
2. Patents Google - Crystalline form of vortioxetine hydrobromide as antidepressant drug.
3. Verified Market Research - Vortioxetine Market Size, Scope, Trends, Growth And Forecast.
4. Market Research Intellect - Shaping the Future of Depression Treatment: The Surge in Vortioxetine Hydrobromide Market Demand.
5. European Medicines Agency - Brintellix, INN-vortioxetine - Public Assessment Report.