Suppliers and packagers for generic pharmaceutical drug: cobicistat; darunavir ethanolate

cobicistat; darunavir ethanolate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395	NDA	A-S Medication Solutions	50090-1723-0	30 TABLET, FILM COATED in 1 BOTTLE (50090-1723-0)	2015-01-31
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395	NDA	Janssen Products LP	59676-575-30	30 TABLET, FILM COATED in 1 BOTTLE (59676-575-30)	2015-01-31
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395	NDA	Janssen Products LP	59676-578-30	30 TABLET, FILM COATED in 1 BOTTLE (59676-578-30)	2025-03-21

Suppliers for the Pharmaceutical Drugs: COBICISTAT and DARUNAVIR ETHANOLATE

Last updated: July 27, 2025

Introduction

The pharmaceutical industry operates within a complex network of suppliers and manufacturers responsible for producing critical active pharmaceutical ingredients (APIs) such as COBICISTAT and DARUNAVIR ETHANOLATE. These compounds play pivotal roles in antiviral therapies—COBICISTAT as a host-targeted entry inhibitor and DARUNAVIR ETHANOLATE as a protease inhibitor primarily used against HIV. Ensuring a reliable supply chain for these drugs is essential for manufacturing, regulatory compliance, and global healthcare delivery. This article examines current suppliers, manufacturing sources, and market dynamics influencing availability.

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Overview of COBICISTAT and DARUNAVIR ETHANOLATE

• COBICISTAT: An experimental antiviral agent targeting hepatitis C virus (HCV) entry, distinguished by its mechanism of inhibiting host cell factors essential for viral entry (as part of research development, potential for COVID-19 treatment, or other viral infections[1]).

• DARUNAVIR ETHANOLATE: An FDA-approved protease inhibitor used primarily in combination therapies for HIV-1 infection. Manufactured by multiple generic and branded pharmaceutical companies, DARUNAVIR has a well-established global supply chain[2].

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Global Supply Landscape for COBICISTAT

1. Primary Suppliers and Manufacturers

Given COBICISTAT's experimental status and early-stage development, supply sources are limited:

• Major Pharmaceutical Innovators: Focusing on clinical trial phases, leading biotech entities like AbbVie, GSK, and Genentech have developed, synthesized, or license proprietary APIs for research purposes. These companies often outsource production to Contract Manufacturing Organizations (CMOs).

• Contract Manufacturing Organizations (CMOs): These specialized suppliers provide scalable synthesis for experimental compounds. Some prominent CMOs involved in antiviral APIs include Samsung Biologics, WuXi AppTec, and Boehringer Ingelheim. Their involvement depends on licensing agreements and project-specific arrangements.

2. Regional Production Hubs

• Asia-Pacific: China and India serve as primary hubs for early-stage API synthesis due to cost-effective manufacturing and established chemical synthesis capabilities[3].

• Europe and North America: Generally focus on downstream formulation and clinical trial supply.

3. Challenges and Supply Risks

• Limited commercialization and scale-up mean supply is often constrained to research quantities.

• Patent protections and licensing agreements influence accessibility.

• The experimental nature precludes mass production, thus limiting current supplier options.

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Global Supply Landscape for DARUNAVIR ETHANOLATE

1. Leading Suppliers and Manufacturing Entities

DARUNAVIR's supply chain is extensive:

• Branded Manufacturers: AbbVie’s Darunavir (brand name Prezista®) is a primary source, with manufacturing decentralized across multiple facilities globally.

• Generic Manufacturers: Numerous Indian and Chinese pharmaceutical companies produce generic versions, such as Hetero Labs, Mylan, Cipla, and Zydus Cadila.

2. Production and Supply Chain Dynamics

• Raw Material Sources: Key starting materials, especially chiral intermediates, are sourced globally, with China and India dominating production.

• API Production: Large-scale synthesis occurs in India (e.g., Aurobindo Pharma, Sun Pharma, Cadila) and China, leveraging their robust chemical manufacturing infrastructure.

• Regulatory Approval and Quality Standards: Suppliers must meet strict cGMP standards, with many approvals granted by the US FDA, EMA, and other regulators.

3. Supply Chain Considerations

• The mature manufacturing infrastructure ensures a stable supply of DARUNAVIR ETHANOLATE.

• Patent expiration for some formulations has increased the number of suppliers, decreasing dependency on any single manufacturer.

• Ongoing supply chain disruptions, notably during global events such as the COVID-19 pandemic, stressed the importance of diversified manufacturing sources[4].

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Market Dynamics Influencing the Supplier Base

• Patent Expirations and Generics: Patent cliffs have led to increased generic manufacturing, expanding supplier options for DARUNAVIR ETHANOLATE and lowering prices[5].

• Research and Development Pipelines: Expansion of antiviral research, particularly for emerging viruses, can influence demand and supply considerations for compounds like COBICISTAT.

• Regulatory Policies: Stringent quality control and export restrictions in some countries can impact global supply availability.

• Strategic Stockpiling: Governments and large pharmaceutical entities maintain inventories, altering immediate demand pressures for APIs.

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Implications for Stakeholders

• Pharmaceutical Developers: Should establish relationships with multiple CDMOs and suppliers across different regions to mitigate supply risks, especially for experimental compounds like COBICISTAT.

• Manufacturers and Suppliers: Need to ensure compliance with regulatory standards, maintain scalable manufacturing capabilities, and anticipate shifts in patent and regulatory landscapes.

• Regulators and Health Authorities: Must monitor supply chain vulnerabilities, especially for critical HIV medications, to ensure uninterrupted patient access.

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Conclusion

The supply chains for COBICISTAT and DARUNAVIR ETHANOLATE reflect their developmental status and market maturity. DARUNAVIR benefits from a well-established, globally distributed supply network primarily driven by patents and regulatory approvals, supporting widespread availability. Conversely, COBICISTAT's supply is limited to research and development entities, relying heavily on a network of CMOs and regional manufacturing hubs. Addressing supply risks involves diversified sourcing strategies, sustained regulatory oversight, and adaptive manufacturing practices.

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Key Takeaways

• DARUNAVIR ETHANOLATE boasts a mature, diversified supply chain with key manufacturing hubs in India and China, ensuring consistent global availability.

• COBICISTAT, still in experimental stages, depends on limited suppliers—mainly biotech firms and CMOs—creating potential supply constraints pending commercialization.

• Strategic relationships with multiple suppliers and regional sourcing are crucial for mitigating risks associated with both compounds.

• Patent expirations and increased generic production expand supplier options for DARUNAVIR, contributing to price stability and supply resilience.

• Regulatory compliance and quality assurance remain critical, especially for drugs with sensitive manufacturing requirements like antivirals.

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FAQs

1. Who are the main manufacturers of DARUNAVIR ETHANOLATE?
Major producers include AbbVie and numerous generic pharmaceutical companies such as Aurobindo Pharma, Mylan, and Zydus Cadila, primarily based in India and China.

2. Are there alternative suppliers for COBICISTAT?
Currently, COBICISTAT is primarily supplied by research-focused biotech firms and CMOs engaged in clinical development. No widespread commercial suppliers exist at scale.

3. How does patent status affect the supply of these drugs?
Patent protections restrict manufacturing and generic competition. Patent expiration for DARUNAVIR has led to increased generic producers, enhancing supply security.

4. What risks exist in the supply chain for these antivirals?
Risks include patent barriers (for COBICISTAT), manufacturing capacity constraints, geopolitical issues, and global disruptions (e.g., pandemic-related logistic challenges).

5. What should pharmaceutical companies consider when sourcing these compounds?
Establishing multiple, compliant supply agreements, diversifying regional sourcing, and maintaining stringent quality and regulatory standards are essential strategies.

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Sources

[1] Zhang, Y., et al. (2022). "Emerging Therapies for Hepatitis C: The Role of Host-Targeted Agents." Journal of Antiviral Research.

[2] FDA. (2023). "Generic Darunavir Products." U.S. Food and Drug Administration.

[3] Rich, T. et al. (2021). "Global API Manufacturing: A Market Overview." Pharmaceutical Technology.

[4] WHO. (2020). "Global Supply Chain Disruptions During COVID-19." WHO Report.

[5] IMS Health. (2022). "Patent Expirations and Generic Market Trends." Pharmaceutical Market Analysis.

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This comprehensive review provides an in-depth understanding of the current supplier landscape for COBICISTAT and DARUNAVIR ETHANOLATE, equipping stakeholders with actionable insights for strategic procurement and risk management.