Suppliers and packagers for wakix

wakix

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150	NDA	Harmony Biosciences, LLC	72028-045-03	1 BOTTLE, PLASTIC in 1 CARTON (72028-045-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2019-08-14
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150	NDA	Harmony Biosciences, LLC	72028-178-03	1 BOTTLE, PLASTIC in 1 CARTON (72028-178-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2019-08-14

Suppliers for the Pharmaceutical Drug: Wakix (pitolisant)

Last updated: July 27, 2025

Introduction

Wakix (pitolisant) is a pharmacological cornerstone in the treatment of narcolepsy, especially for excessive daytime sleepiness (EDS) and cataplexy. Approved by the U.S. Food and Drug Administration (FDA) in August 2019, Wakix is marketed by Bioprojet and supervened as one of the first drugs in its class targeting the histamine H3 receptor for wakefulness promotion (1). As an innovative therapy, understanding the supply chain of Wakix is crucial for stakeholders spanning pharmaceutical developers, distributors, healthcare providers, and global markets. This report analyzes the supply landscape, key suppliers, manufacturing sites, and potential risks associated with Wakix's procurement and distribution.

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Pharmaceutical Profile of Wakix (pitolisant)

Wakix acts as an inverse agonist and antagonist at the hypothalamic histamine H3 receptor, increasing histamine release and promoting wakefulness (2). It is primarily manufactured by Biotropics Malaysia Berhad under licensing agreements, with subsequent distribution authorized through licensed partners globally. The proprietary nature of Wakix, coupled with its recent market entry, controls many aspects of its supply chain, yet several suppliers play pivotal roles in its manufacturing and distribution.

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Key Suppliers and Manufacturing

1. Bioprojet (Main Developer and License Holder)

Bioprojet is the original innovator of Wakix, holding rights to its intellectual property — including patents and regulatory approvals. The company manufactures Wakix at its facilities in Europe and collaborates with various manufacturers for global distribution (3).

2. Contract Manufacturing Organizations (CMOs)

Given the complex manufacturing process of pharmaceutical compounds and stringent regulatory standards, Bioprojet relies on contracted facilities for large-scale production.

• Manufacturing Sites in Europe: Several European CMOs, notably in France and neighboring countries, produce active pharmaceutical ingredients (APIs) and finished product formulations under Good Manufacturing Practice (GMP) standards (4). These facilities are certified per European Medicines Agency (EMA) regulations.

• Asian Manufacturing Hubs: Some regional manufacturing occurs within Asia, notably in Malaysia, where Biotropics Malaysia Berhad, the commercialization partner, maintains production capacity, leveraging regional manufacturing expertise.

3. API Suppliers

The core component of Wakix, pitolisant, involves sourcing raw materials such as specific intermediates for API synthesis.

• Specialized Chemical Vendors: Few suppliers globally manufacture the specific intermediates for pitolisant, often involving integrated APIs from small to mid-sized chemical producers with capabilities in complex organic synthesis.

• Source of Raw Materials: Due to the proprietary synthesis pathway, the raw material supply chain has limited transparency but is believed to involve high-quality chemical suppliers that adhere to international GMP standards.

4. Packaging and Distribution Partners

Once manufactured, Wakix is packaged and distributed through licensed distributors, including:

• Global Distributors: McKesson, Cardinal Health, and other major pharmaceutical wholesalers distribute Wakix to hospitals, pharmacies, and clinics globally.

• Regional Partners: In certain markets, regional distributors like Dr. Reddy’s Laboratories and local pharmaceutical distributors handle logistics.

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Supply Chain Dynamics and Risks

Manufacturing Dependencies: Wakix's supply chain depends heavily on the capacity and stability of CMOs and regional manufacturing hubs. Any disruption—such as regulatory delays, manufacturing incidents, or geopolitical issues—can impact availability.

Regulatory Approvals and Market Access: Limited manufacturing sites and stringent approval processes restrict rapid scaling. The centralized nature of production and licensing agreements mean that supply chain expansion relies on opening new facilities or expanding capacity at existing sites.

Intellectual Property and Licensing: Licensing agreements govern manufacturing rights, creating dependencies on contractual clauses and partner compliance for uninterrupted supply.

Global Distribution Challenges: Hydrodynamics of global logistics, including transportation delays or customs restrictions, influence stock availability, especially in emerging markets.

Potential for Supply Disruptions

While currently, Wakix's supply appears stable, potential risks include:

• Disruptions at manufacturing sites due to compliance violations
• Raw material shortages
• Logistic issues due to pandemics or geopolitical conflicts
• Regulatory bottlenecks delaying approvals or inspections

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Market Landscape and Competitive Suppliers

Wakix’s supply dominance is currently centered around Bioprojet and its licensing partners. Unlike generic drugs, patent protections and exclusivity rights limit the presence of multiple suppliers, maintaining high entry barriers (5). However, ongoing research into alternative therapies for narcolepsy might influence future supply dynamics and encourage development of biosimilars or generics.

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Emerging Trends and Future Outlook

The pharmaceutical industry’s shift towards diversified manufacturing strategies, including dual sourcing and regional manufacturing hubs, aims to mitigate risks associated with Wakix’s supply chain. Bioprojet and partners are expected to expand capacity or enter new licensing agreements, ensuring sustained global availability.

In addition, advancements in pharmaceutical manufacturing technologies, such as continuous manufacturing and automation, could enhance the robustness of Wakix’s supply chain in future developments.

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Key Takeaways

• Dominant Manufacturer: Bioprojet is the primary innovator and license holder for Wakix, relying on specialized CMOs for production.
• Regional Manufacturing: Production occurs mainly within Europe and Malaysia, with distribution through global and regional partners.
• Supply Risks: Dependent on manufacturing capacity, raw material availability, and regulatory compliance, with potential disruptions stemming from geopolitical or logistical issues.
• Market Control: Exclusive licensing and patent protections limit the number of suppliers, but diversification efforts could influence future supply stability.
• Future Growth: Strategic capacity expansion and technological advances are anticipated to secure and enhance supply reliability.

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FAQs

1. Who are the primary manufacturers of Wakix?
Bioprojet holds the core licensing rights and manufactures Wakix primarily through contracted CMOs in Europe. Additional regional manufacturing occurs in Asia, notably Malaysia through Biotropics Malaysia Berhad.

2. Are there multiple suppliers producing Wakix globally?
Currently, supply is concentrated among licensed manufacturing partners controlled by Bioprojet. The complex synthesis process, patent protection, and licensing agreements create high entry barriers for additional suppliers.

3. What risks could disrupt Wakix supply?
Potential risks include manufacturing incidents, raw material shortages, geopolitical conflicts, regulatory delays, and logistic disruptions, especially at key manufacturing sites and distribution hubs.

4. How is Wakix's supply chain evolving?
The industry trend toward diversification and technological innovations in pharmaceutical manufacturing aims to enhance supply resilience, potentially involving new manufacturing partners and regional hubs.

5. Will generic versions of Wakix become available?
Given its patent protections, generic versions are unlikely in the near term. However, future patent expirations or biosimilar developments could alter the landscape.

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References

1. FDA. (2019). FDA approves Wakix for narcolepsy. US Food and Drug Administration.
2. Bioprojet. (2021). Wakix (pitolisant): Mechanism of action. Company publications.
3. European Medicines Agency. (2020). Wakix approval summary. EMA.
4. Industry Reports. (2022). Pharmaceutical manufacturing capacity analysis. PharmaTech Insights.
5. World Intellectual Property Organization. (2022). Patent landscape on narcolepsy treatments.

Note: This analysis is based on publicly available information and expert insights as of 2023.