Suppliers and packagers for generic pharmaceutical drug: ATAZANAVIR SULFATE; COBICISTAT

ATAZANAVIR SULFATE; COBICISTAT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bristol	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353	NDA	E.R. Squibb & Sons, L.L.C.	0003-3641-11	30 TABLET in 1 BOTTLE (0003-3641-11)	2015-01-29

Suppliers for the Pharmaceutical Drugs: Atazanavir Sulfate and Cobicistat

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for antiretroviral therapy (ART) drugs like atazanavir sulfate and cobicistat is characterized by a complex global supply chain involving multiple manufacturers, generic producers, and authorized distributors. These agents are pivotal in HIV treatment, with atazanavir sulfate serving as a protease inhibitor and cobicistat functioning as a pharmacokinetic enhancer. Understanding the key suppliers, their geographic distribution, manufacturing capabilities, and regulatory status is essential for stakeholders seeking reliable sources, whether for clinical procurement, distribution, or strategic partnerships.

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Atazanavir Sulfate Suppliers

1. Origin and Development

Atazanavir sulfate is a widely prescribed antiretroviral protease inhibitor first developed by Bristol-Myers Squibb (BMS). Its global demand necessitates a diverse supplier base, including original patent holders, authorized generic manufacturers, and various contract manufacturing organizations (CMOs).

2. Leading Manufacturers and Suppliers

• Bristol-Myers Squibb (BMS):
  As the originator, BMS holds the primary patent rights for atazanavir sulfate, overseeing initial production and global supply through its manufacturing facilities, primarily located in Puerto Rico, Ireland, and the United States (as of 2022). BMS's authorized distribution channels ensure supply chain integrity and quality assurance.

• Generic Manufacturers:
  Following patent expiration or licensing agreements, multiple generic companies have entered the market:

  • Mylan (now Viatris):
    Manufactured at facilities in India and the United States, Viatris is a prominent generic supplier of atazanavir sulfate. It has received approvals from major regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) (see [1]).

  • Hetero Drugs:
    Based in India, Hetero is recognized for producing affordable generics of antiretrovirals, including atazanavir sulfate, with WHO prequalification status enhancing their credibility for global procurement ([2]).

  • Sun Pharmaceutical Industries:
    Indian-based Sun Pharma manufactures atazanavir sulfate for various markets, leveraging its extensive API production capabilities.

  • Cadila Healthcare:
    Also based in India, Cadila produces generic formulations with approvals in multiple jurisdictions.

• Contract Manufacturing Organizations (CMOs):
  Several CMOs in India, China, and Eastern Europe provide large-scale production capacities for atazanavir sulfate, often under licensing agreements with originators or generic firms.

3. Regulatory & Market Access

Authorized generics from Indian and Chinese manufacturers are cost-effective options widely used in resource-limited settings. Many of these companies have obtained WHO prequalification or US FDA approval, facilitating procurement for international health agencies.

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Cobicistat Suppliers

1. Role and Development

Cobicistat, marketed under the tradename Tybost, was developed by Gilead Sciences as a pharmacokinetic enhancer to boost the efficacy of co-administered antiretrovirals, notably atazanavir and darunavir. Since its approval in 2015, supply chain management has involved Gilead's production facilities and licensed generic manufacturers.

2. Leading Suppliers

• Gilead Sciences:
  As the patent holder and sole original manufacturer, Gilead controls the production of cobicistat, primarily through facilities in the United States and Europe. Gilead’s global distribution network ensures consistent supply for branded formulations.

• Authorized Generic and Licensing Partners:
  In 2020, Gilead entered into licensing agreements to allow generic manufacturers to produce cobicistat in certain jurisdictions, expanding supply options:

  • MediCen (India):
    Licensed through Gilead, MediCen produces generic cobicistat for developing markets, obtaining necessary regulatory approvals, including WHO prequalification.

  • Hetero Drugs:
    Indian-based Hetero also manufactures cobicistat via licensing agreements, supporting access in low- and middle-income countries ([3]).

• Contract Manufacturing and Exporters:
  Multiple CMOs in India and China serve as production partners under Gilead's licensing framework, expanding manufacturing capacity worldwide.

3. Regulatory Status & Market Distribution

Gilead’s proprietary rights dominate the mainstream supply chain, but the advent of licensed generics has improved accessibility, particularly by reducing cost barriers in emerging markets. Their WHO prequalification facilitates procurement for global health initiatives like PEPFAR and the Global Fund.

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Global Supply Dynamics and Challenges

• Patent and Intellectual Property Rights:
  Patent expirations, licensing agreements, and patent litigations shape the supplier landscape. While the original patents control early supply, generic entry typically follows patent expiry or licensing.

• Regulatory Approvals & Quality Assurance:
  Suppliers must meet rigorous standards set by FDA, EMA, WHO, and local regulators to ensure drug quality, safety, and efficacy.

• Supply Chain Risks:
  Dependency on manufacturing hubs in India, China, and other emerging economies introduces risks related to geopolitical instability, regulatory changes, and manufacturing disruptions (e.g., COVID-19 pandemic effects).

• Pricing & Accessibility:
  Generic manufacturers play a vital role in reducing costs. However, disparities in regulatory recognition and patent enforcement continue to influence supply channels and pricing strategies worldwide.

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Key Considerations for Stakeholders

• Procurement Strategies:
  Public health agencies and private buyers should prioritize suppliers with robust regulatory approvals and WHO prequalification to ensure quality.

• Licensing Opportunities:
  Engaging with licensed generic manufacturers can improve supply security and cost-efficiency for countries with limited patent rights or licensing agreements.

• Monitoring Regulatory Status:
  Continuous review of approvals and patent statuses is necessary to adapt procurement plans and mitigate supply shortages.

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Conclusion

The supply chain for atazanavir sulfate and cobicistat reflects a convergence of original patent-holders, authorized generics, and licensed manufacturers across diverse geopolitical regions. Typically, Indian pharmaceutical companies dominate generic production, leveraging local manufacturing expertise and global distribution networks. Gilead’s licensing agreements have expanded the supply base for cobicistat, facilitating broader access.

For stakeholders in healthcare procurement and strategic planning, staying updated on regulatory approvals, patent statuses, and manufacturing capacities is crucial for ensuring uninterrupted, high-quality supply of these pivotal antiretroviral agents.

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Key Takeaways

• The original patent holders, notably Bristol-Myers Squibb (atazanavir) and Gilead Sciences (cobicistat), currently dominate the supply chain, with licensed generics expanding access.
• Indian pharmaceutical companies such as Mylan, Hetero, Sun Pharma, and Cadila are primary producers of generic atazanavir sulfate; licensed manufacturers like MediCen and Hetero supply generic cobicistat.
• Regulatory approvals (FDA, EMA, WHO prequalification) are crucial indicators for procurement reliability and quality.
• Patent expirations and licensing agreements influence global supply dynamics and competitive pricing.
• Diversified manufacturing sources, especially in India and China, are essential for meeting global demand and mitigating supply risks.

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References

[1] FDA Drug Approvals and Label Information. U.S. Food and Drug Administration, 2022.
[2] WHO Prequalification of Medicines Program. World Health Organization, 2022.
[3] Gilead Sciences Licensing Agreements. Gilead corporate disclosures, 2022.