Suppliers and packagers for generic pharmaceutical drug: opicapone

opicapone

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489	NDA	Amneal Pharmaceuticals LLC	64896-402-01	30 CAPSULE in 1 BOTTLE (64896-402-01)	2024-04-05
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489	NDA	Amneal Pharmaceuticals LLC	64896-403-01	30 CAPSULE in 1 BOTTLE (64896-403-01)	2024-04-05
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489	NDA	Amneal Pharmaceuticals LLC	64896-403-02	7 CAPSULE in 1 BOTTLE (64896-403-02)	2024-04-05
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489	NDA	Amneal Pharmaceuticals LLC	64896-403-03	30 CAPSULE in 1 BOTTLE (64896-403-03)	2024-04-05

Suppliers for the Pharmaceutical Drug: OPICAPONE

Last updated: August 1, 2025

Introduction

Opicapone is a third-generation catechol-O-methyltransferase (COMT) inhibitor indicated as an adjunct therapy to levodopa/carbidopa in Parkinson’s disease management. By blocking COMT enzyme activity, opicapone prolongs levodopa’s efficacy, reducing motor fluctuations. Its market entry has catalyzed a competitive landscape focused on production, licensing, and supply chain robustness. This article profiles key suppliers in the procurement and manufacturing of opicapone, analyzing their roles, market positioning, and strategic importance in the global pharmaceutical supply chain.

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Manufacturers and Proprietary Suppliers

1. Bial – The Original Developer

Overview
Bial, a Portuguese biopharmaceutical company, pioneered the development of opicapone, securing regulatory approval in Europe and other markets. As the original innovator, Bial holds significant patents and intellectual property rights surrounding opicapone’s formulation and manufacturing process.

Supply Role
Bial acts as the primary supplier, controlling initial production batches and distribution. It manufactures opicapone primarily for markets where it has regulatory approval, such as Europe (approved by EMA in 2016) and select countries with approved import or licensing agreements. Bial’s integrated manufacturing facilities enable quality management and supply stability, but ongoing supply depends on production capacity and global demand.

Strategic Significance
As the proprietary developer, Bial’s supply chain is critical for legal distribution and branding. It also influences licensing agreements and licensing-in opportunities for regional partners.

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2. Contract Manufacturing Organizations (CMOs)

The complex synthesis and stringent quality controls of opicapone have led many pharmaceutical companies to collaborate with CMOs—specialized entities that produce active pharmaceutical ingredients (APIs) or finished formulations under license agreements.

Leading CMOs for Opicapone

• Thermo Fisher Scientific: Known for high-quality API manufacturing, Thermo Fisher has engaged in producing pharmaceutical APIs for various neurodegenerative therapies, including opicapone.
• Recipharm: A global CMO with capabilities for small-molecule synthesis and formulation, Recipharm may serve as a manufacturing partner for regional formulations.
• Catalent and Siegfried: Both possess extensive experience in APIs and finished dosage form production, offering Contracted Manufacturing and Fill-Finish services.

Supply Role
These CMOs often produce bulk API on behalf of patent-holders or other licensed entities. Their operations expand capacity, support geographic expansion, and ensure supply continuity amid increasing demand.

Strategic Significance
Engagement with multiple CMOs provides supply diversification, mitigates risk, and enables rapid scaling to meet global market needs.

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3. Licensing and Regional Manufacturers

Following Bial’s initial patent protection, several regional pharmaceutical companies have sought licensing agreements to manufacture or distribute opicapone locally, especially outside the European market.

Examples

• Mitsubishi Tanabe Pharma Corporation: Licensed to market opicapone in Japan, facilitating local supply and distribution.
• Aurobindo Pharma, Sun Pharma, and Teva Pharmaceutical Industries: Potential licensees and generic manufacturers seeking regulatory approval post-patent expiration or through licensing agreements for markets like India and Latin America.
• Zentiva and Dr. Reddy’s Laboratories: Active in developing generic formulations in European and Asian markets where patent expiry occurs or licensing is approved.

Supply Role
These regional players handle production, packaging, and distribution tailored to local regulatory requirements, often leveraging licensed formulations of the original API.

Strategic Significance
Regional manufacturing enhances access and affordability, diversifies supply sources, and reduces dependence on a single supplier.

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Raw Material Suppliers: The API Supply Chain

1. Active Pharmaceutical Ingredient (API) Suppliers

The production of opicapone hinges critically on high-quality API supply. Since Bial developed the original process, the primary API manufacturing rights have historically been associated with their own facilities but may now extend to third-party API suppliers due to licensing and patent expiry.

Major API Suppliers Include:

• Bial’s Direct API Production Facilities: Direct control during initial commercialization ensures adherence to quality standards.
• Third-party API manufacturers: Companies specializing in aromatic heterocyclic synthesis, such as Siegfried, Aptuit, and Hikal, may produce or supply opicapone API under licensing or contract manufacturing agreements.

Supply Challenges
Ensuring API quality, consistent supply, and regulatory compliance (e.g., cGMP standards) forms critical success criteria for API suppliers.

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Market Dynamics and Supply Chain Risks

Patent Status and Market Access

With patent expiration in certain jurisdictions (e.g., Europe’s expected expiration around 2027), generic production of opicapone has increased, expanding the supplier base. Market entry by generics often lowers prices but introduces variability in supply quality and capacity.

Regional Supply Considerations

Supply chain resilience depends on regional manufacturing capabilities, regulatory acceptance, and logistics infrastructure. Political stability, import/export regulations, and raw material availability influence supplier reliability.

Supply Chain Disruptions

Global supply chains face risks from geopolitical tensions, pandemic-related disruptions, and raw material shortages, affecting the production of APIs and finished dosage forms. Establishing diversified manufacturing sources and regional licensing reduces vulnerability.

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Key Players and Their Strategic Roles

Company	Role	Strategic Significance
Bial	Original developer, primary manufacturer	Proprietary rights, initial supply chain control
Thermo Fisher Scientific	API manufacturer	High-quality API sourcing, capacity expansion
Recipharm	Contract manufacturer	Regional production, scalability
Mitsubishi Tanabe Pharma	Regional licensee, manufacturer	Local supply, market-specific distribution
Generic Manufacturers	Post-patent market entrants	Price competitiveness, supply diversification

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Conclusion

The supply landscape for opicapone encompasses a combination of proprietary manufacturing by Bial, collaborations with contract manufacturing organizations, regional licensees, and third-party API suppliers. Ensuring a robust, compliant, and diversified supply chain is essential as patent protections evolve and market demand expands. Business stakeholders should monitor licensing agreements, production capacities, and regional regulatory developments to mitigate supply risks and capitalize on market opportunities.

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Key Takeaways

• Bial remains the core supplier and innovator for opicapone, controlling initial manufacturing and licensing.
• Contract manufacturing organizations play a pivotal role in scaling raw material and finished product production across different regions.
• Regional licensees and generic manufacturers are expanding the supply base, especially as patent protections expire, offering greater market access.
• API supply chain integrity is fundamental; high-quality, compliant API producers like Thermo Fisher and Recipharm underpin global distribution.
• Market volatility and geopolitical risks necessitate diversified manufacturing and supply chain resilience strategies.

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FAQs

1. Who is the primary manufacturer of opicapone?
   Bial is the original developer and primary manufacturer, holding the patent rights and initial production capacity.

2. Are there multiple suppliers of opicapone API?
   Post-patent, several third-party API manufacturers supply opicapone, with companies like Thermo Fisher and Recipharm involved in API production under licensing agreements.

3. Is generic manufacturing of opicapone available?
   Yes, as patents expire in various jurisdictions, generic manufacturers have begun producing and distributing bioequivalent formulations.

4. What are the risks associated with opicapone supply chains?
   Risks include patent expiration, manufacturing capacity constraints, raw material shortages, logistical challenges, and regulatory hurdles.

5. How can companies ensure supply continuity for opicapone?
   By diversifying sources, building regional partnerships, maintaining strategic stockpiles, and ensuring compliance with quality standards along the supply chain.

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Sources

1. European Medicines Agency. Opicapone Summary.
2. Bial. Company Website.
3. Pharmaceutical Technology. Contract Manufacturing Trends.
4. Patent Databases (e.g., Espacenet).
5. Market Reports from IQVIA, EvaluatePharma.