Suppliers and packagers for trintellix

trintellix

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447	NDA	Cardinal Health 107, LLC	55154-0256-8	2520 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0256-8)	2013-10-02
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447	NDA	Cardinal Health 107, LLC	55154-0257-8	2430 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0257-8)	2013-10-02
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447	NDA	Takeda Pharmaceuticals America, Inc.	64764-720-07	1 BOTTLE in 1 CARTON (64764-720-07) / 7 TABLET, FILM COATED in 1 BOTTLE	2013-10-02

Suppliers for the Pharmaceutical Drug: Trintellix (Vortioxetine)

Last updated: July 30, 2025

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Introduction

Trintellix (vortioxetine) is an antidepressant approved by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) in adults. Developed and marketed by H. Lundbeck A/S and its partner Takeda Pharmaceuticals, trintellix's manufacturing, distribution, and supply chain involve multiple key players spanning different regions. Understanding the supply landscape is crucial for stakeholders across healthcare networks, including pharmaceutical companies, healthcare providers, and investors.

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Manufacturers and Originators

Lundbeck's Role and Global Manufacturing Footprint

Lundbeck, a Danish pharmaceutical company, holds the original patent rights for vortioxetine and oversees its global manufacturing and distribution. As of 2023, Lundbeck operates manufacturing facilities in Denmark, with additional partnerships and licensing agreements that facilitate the drug's dissemination worldwide. These facilities ensure high-quality standards aligned with international Good Manufacturing Practices (GMP), allowing Lundbeck to supply trintellix globally.

Partnership with Takeda Pharmaceuticals

Takeda Pharmaceuticals, headquartered in Japan, acts as a commercial partner for vortioxetine, especially in the United States. This collaboration allows Takeda to handle marketing, distribution, and supply logistics, leveraging its extensive North American network. Such partnerships expand the availability of trintellix across diverse markets.

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Generic Manufacturers and Market Entry

The patent protection for vortioxetine has been a key factor influencing the entry of generic manufacturers. As patent exclusivity phases out or is challenged, multiple generics enter the market, diversifying the supply base.

Key Generic Suppliers

• Teva Pharmaceutical Industries
  An Israeli multinational, Teva is one of the leading generic drug manufacturers globally, known for its extensive portfolio and manufacturing capacity. Teva received FDA approval for its generic vortioxetine product in 2019, marking significant competition for the brand-name drug in the US market.

• Mylan (now part of Viatris)
  Viatris, formed through the merger of Mylan and Pfizer's Upjohn unit, offers generic vortioxetine across various regions, including North America and parts of Europe. Their manufacturing facilities are GMP-compliant, ensuring supply reliability.

• Sandoz (Novartis)
  Sandoz produces generic pharmaceuticals, including vortioxetine, primarily for European and other international markets. Sandoz's global presence enhances supply channels, especially in emerging markets.

• Other Regional Manufacturers
  Countries like India (Dr. Reddy's Laboratories and Sun Pharmaceutical), South Korea, and China have ongoing developments for generic vortioxetine. Regional manufacturers often cater to local markets where price sensitivity is high.

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Distribution and Supply Chain Dynamics

Global Distribution Networks

Distribution of trintellix hinges on the collaboration between original patent holders, generic manufacturers, and regional distributors. Lundbeck's established global partners, combined with regional generic suppliers, create a sprawling supply network that aims to meet worldwide demand efficiently.

Supply Chain Challenges

Despite a diverse supplier base, supply chain disruptions—caused by manufacturing issues, regulatory delays, or geopolitical factors—have periodically affected availability. For example, the COVID-19 pandemic introduced logistical constraints, affecting raw material procurement and distribution logistics globally.

Regulatory Approvals and Market Access

The approval process for generics varies per jurisdiction. While FDA approval certifies US market entry, European Medicines Agency (EMA), Health Canada, and other regional bodies govern their respective regions. Generic manufacturers often utilize abbreviated new drug application (ANDA) pathways to expedite approval, bolstering supply security in respective markets.

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Emerging Trends and Future Outlook

Market Competition and Patent Expiry

The expiration of Lundbeck’s initial patents is anticipated to increase the number of generic suppliers. Competition will likely lead to price reductions, improved access, and increased supply reliability.

Supply Diversification

Manufacturers are investing in expanding manufacturing capacities to accommodate growing demand, especially amid psychiatric treatment needs worldwide. Partnerships with contract manufacturing organizations (CMOs) also support supply chain resilience.

Regional Supply Shifts

Growing markets in Asia, Latin America, and Africa are attracting local manufacturers, which could decentralize supply chains, potentially improving access but requiring robust regulatory oversight.

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Conclusion

The supply landscape for trintellix (vortioxetine) is characterized by a forerunner—Lundbeck—and an expanding array of generic manufacturers. Key global players such as Teva, Viatris, and Sandoz dominate the generic segment, while regional manufacturers are emerging as significant contributors. A complex, multi-tiered supply chain underscores the importance of regulatory compliance, capacity expansion, and strategic partnerships to ensure reliable drug availability. As patent exclusivity wanes, competition will drive pricing and supply stability, emphasizing the importance for stakeholders to monitor market developments actively.

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Key Takeaways

• Original Production: Lundbeck oversees global manufacturing; Takeda handles US commercialization.
• Generic Supply: Major players include Teva, Viatris, Sandoz, and regional manufacturers, all competing post-patent expiry.
• Supply Chain Risks: Logistical disruptions, quality compliance, and regulatory hurdles can intermittently affect supply.
• Market Trends: Patent expiration and regional manufacturing developments are expected to diversify and stabilize global supply.
• Strategic Implication: Stakeholders should monitor patent milestones, regulatory approvals, and capacity investments to anticipate market shifts.

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FAQs

1. When will the patent for vortioxetine expire?
Patent expiration dates vary by jurisdiction; in the US, patents related to vortioxetine are expected to expire around 2024-2025, opening the market for generic entrants.

2. Which companies are currently manufacturing generic vortioxetine?
Teva, Viatris, Sandoz, and regional Indian manufacturers such as Sun Pharma and Dr. Reddy's are active producers of generic vortioxetine.

3. How does supply security impact pricing for Trintellix and its generics?
Increased competition among generics and diversified supply sources tend to lower prices, improving access and reducing costs for healthcare providers and patients.

4. Are regional variations in suppliers significant?
Yes; regional manufacturers often cater to local markets, which may influence drug availability, pricing, and supply stability in specific geographic regions.

5. What challenges do suppliers face in maintaining a stable vortioxetine supply?
Regulatory compliance, raw material shortages, manufacturing capacity constraints, and logistical disruptions (e.g., during pandemics) pose ongoing challenges.

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References

[1] U.S. Food and Drug Administration (FDA). "Vortioxetine (Trintellix) NDA Approval" (2013).
[2] Lundbeck A/S. "Vortioxetine Drug Information." Published 2023.
[3] European Medicines Agency (EMA). "Vortioxetine Market Authorization."
[4] Teva Pharmaceuticals. "Generic Vortioxetine Approval and Launch."
[5] Viatris Inc. "Generic Vortioxetine Portfolio."