TRINTELLIX Drug Patent Profile

Which patents cover Trintellix, and when can generic versions of Trintellix launch?

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 sixteen 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. Two 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:	216
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	11
Patent Applications:	79
Drug Prices:	Drug price information for TRINTELLIX
Drug Sales Revenues:	Drug sales revenues 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 three 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	204447-004	Sep 30, 2013		RX	Yes	Yes					Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013		RX	Yes	Yes

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	204447-003	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 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
Eurasian Patent Organization	201070598	ТЕРАПЕВТИЧЕСКОЕ ПРИМЕНЕНИЕ СОЕДИНЕНИЙ, ОБЛАДАЮЩИХ КОМБИНИРОВАННОЙ АКТИВНОСТЬЮ В ОТНОШЕНИИ SERT, 5-HTИ 5-HT
Malaysia	150647	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
Portugal	2044043
Portugal	2431039
Japan	2007051149	PHENYLPIPERAZINE DERIVATIVE AS SEROTONIN REUPTAKE INHIBITOR

Supplementary Protection Certificates for TRINTELLIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C01436271/01	Switzerland		PRODUCT NAME: VORTIOXETINE; REGISTRATION NO/DATE: SWISSMEDIC 65937 09.06.2016
1436271	2014C/036	Belgium		PRODUCT NAME: VORTIOXETINE; AUTHORISATION NUMBER AND DATE: EU/1/13/891 20131220
1436271	C300652	Netherlands		PRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
1436271	PA2014013	Lithuania		PRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218

TRINTELLIX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Trintellix (Vortioxetine)

Introduction to Trintellix

Trintellix, also known as vortioxetine, is a medication approved for the treatment of Major Depressive Disorder (MDD). It is marketed by Lundbeck and Takeda Pharmaceuticals and has been a significant player in the antidepressant market.

Market Drivers

The market for Trintellix is driven by several key factors:

Heightened Mental Health Awareness

Increased awareness and reduced stigma around mental health have led to more individuals seeking treatment for depressive symptoms, driving the demand for Trintellix[1].

Personalized Treatment Approaches

The trend towards personalized medicine has contributed to the growth of Trintellix, as healthcare providers tailor treatment plans to meet the specific needs of patients[1].

Expansion of Telemedicine

The growth of telemedicine and online mental health services has made it easier for individuals to access Trintellix prescriptions and consultations, especially in remote or underserved areas[1].

Improved Healthcare Policies and Insurance Coverage

Evolving healthcare policies and insurance reforms have improved access to mental health services and medications, including Trintellix, making it more affordable and accessible[1].

Market Performance

Revenue Growth

Trintellix has shown significant revenue growth. In the first quarter of 2024, revenue from Trintellix reached DKK 1,168 million, representing an 11% growth in constant exchange rates (CER) compared to the same period in 2023[2].

Geographical Performance

The largest markets for Trintellix include the U.S., Canada, Spain, Italy, and France. In Europe, particularly, Trintellix has seen strong performance, contributing to the overall growth of Lundbeck's strategic brands[2][5].

Financial Trajectory

Revenue and Sales

Trintellix has been a top-selling drug in the MDD market, with sales of $904 million in 2019. Despite facing competition and generic erosion, it continues to contribute significantly to Lundbeck's revenue. For instance, in the first half of 2024, Trintellix revenue grew by 11% CER[2][4].

Operating Expenses and Profitability

Lundbeck's financial reports indicate that the company has seen an increase in operating expenses, but this has been offset by strong revenue growth. The EBIT (profit from operations) for Lundbeck increased by 9% in the first quarter of 2024, with Trintellix contributing to this growth. The EBITDA margin for Lundbeck was 33.0%, reflecting the profitability of its strategic brands, including Trintellix[2][5].

Adjusted EBITDA and Net Profit

Adjusted EBITDA for Lundbeck increased to DKK 3,365 million in the first half of 2024, with Trintellix being a key contributor. The net profit for Lundbeck also saw a significant increase, reaching DKK 1,006 million in the first quarter of 2024, up 14% from the previous year[2][5].

Challenges and Future Outlook

Generic Erosion

One of the significant challenges facing Trintellix is the impending patent expiry, which will lead to the entry of cheaper generics into the market. This is expected to result in sales erosion for Trintellix and other strategic brands of Lundbeck[4].

Market Competition

The MDD market is highly competitive, with other drugs like Rexulti and emerging pipeline products such as aticaprant from Johnson & Johnson. Aticaprant, with its novel mechanism of action focusing on anhedonia, is expected to see strong uptake and could pose a competitive threat to Trintellix[4].

Regulatory and Economic Considerations

Regulatory Procedures and Approvals

Setting up a Trintellix manufacturing plant involves navigating complex regulatory procedures and obtaining necessary approvals. This includes compliance with various certifications and financial assistance requirements[1].

Project Economics

The economic viability of a Trintellix manufacturing plant is analyzed through detailed project economics, including capital investments, operating expenses, income projections, and financial analysis such as ROI and NPV. These analyses are crucial for understanding the feasibility and profitability of such a project[1].

Pros and Cons of Trintellix

Pros

• Trintellix can be prescribed in an outpatient setting.
• It is often reimbursed by insurance providers, making it more affordable.
• It has been found to have similar adverse event profiles compared to other antidepressants, except at higher dosages[3].

Cons

• Trintellix poses risks such as increased suicidal thoughts in users under 25, serotonin syndrome, and bleeding issues.
• It can cause psychological dependence and physical withdrawals.
• Use during pregnancy can result in newborn withdrawals[3].

Key Takeaways

• Trintellix is driven by increased mental health awareness, personalized treatment approaches, and expanded telemedicine services.
• The drug has shown significant revenue growth, particularly in key markets like the U.S. and Europe.
• Despite facing challenges such as generic erosion and market competition, Trintellix remains a profitable asset for Lundbeck.
• Regulatory and economic considerations are crucial for the setup and operation of a Trintellix manufacturing plant.

FAQs

Q: What is Trintellix used for? A: Trintellix (vortioxetine) is used for the treatment of Major Depressive Disorder (MDD).

Q: What are the key drivers of the Trintellix market? A: The market is driven by heightened mental health awareness, personalized treatment approaches, expanded telemedicine services, and improved healthcare policies.

Q: How has Trintellix performed financially? A: Trintellix has shown significant revenue growth, with an 11% increase in CER in the first quarter of 2024 compared to the same period in 2023.

Q: What are the potential risks associated with Trintellix? A: Risks include increased suicidal thoughts in users under 25, serotonin syndrome, bleeding issues, and psychological dependence.

Q: What challenges does Trintellix face in the future? A: Trintellix faces challenges such as generic erosion and competition from emerging pipeline products.

Citations

1. IMARC Group, "Vortioxetine (Trintellix) Manufacturing Plant Project Report 2024: Industry Trends, Plant Setup, Machinery, Raw Materials, Investment Opportunities, Cost and Revenue"
2. Lundbeck, "Q1 2024 Corporate Release Final"
3. Alternative to Meds, "Pros and Cons of Using Trintellix to Treat Severe Depression"
4. Clinical Trials Arena, "Major depressive disorder market to reach $9.6bn across 8MM by 2029"
5. Lundbeck, "Q2 2024 Final"