Suppliers and packagers for generic pharmaceutical drug: cabotegravir sodium

cabotegravir sodium

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887	NDA	ViiV Healthcare Company	49702-248-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-248-13)	2021-01-21

Last updated: July 27, 2025

ppliers for the Pharmaceutical Drug: CABOTEGRAVIR SODIUM

Introduction
Cabotegravir sodium is a vital component in the landscape of modern antiretroviral therapy (ART), particularly for HIV treatment and prevention. As a potent integrase inhibitor, it forms the backbone of long-acting injectable regimens, offering improved adherence and patient outcomes. The global supply chain for cabotegravir sodium involves various pharmaceutical manufacturers, licensure arrangements, and regulatory approvals. This article examines the key suppliers, manufacturing landscape, and strategic considerations influencing cabotegravir sodium's availability.

Market Overview
Cabotegravir sodium's prominence surged with the development of long-acting formulations approved by leading health authorities. Gilead Sciences, Inc., was among the first to advance this compound through clinical trials and seek regulatory approval, positioning itself as a primary producer and supplier globally. Besides Gilead, other biopharmaceutical entities have entered the market via licensing agreements and contract manufacturing arrangements to meet rising demand.

Leading Suppliers and Manufacturers

1. Gilead Sciences, Inc.
Gilead holds the original patent rights and has been a dominant force in the supply of cabotegravir sodium. The company's proprietary formulations include injectable long-acting cabotegravir, marketed under the brand name Apretude (for HIV prevention) and Cabenuva (as part of two-drug regimens for HIV treatment). Gilead's integrated manufacturing facilities in the U.S. and internationally ensure proprietary control over active pharmaceutical ingredient (API) production. Its robust distribution channels and strategic alliances solidify its position as a leading supplier.

2. Patent and Licensing Agreements
Gilead has engaged in licensing partnerships with generic manufacturers to expand global access, especially in low- and middle-income countries (LMICs). Such agreements often involve technology transfer, facilitating local API production. Noteworthy licensees include major players in India and China, where local manufacturing can meet regional demands.

3. Contract Manufacturing Organizations (CMOs)
Beyond Gilead, CMOs like Jiangsu Hengrui Medicine and Sinocare have expressed capacities to produce cabotegravir sodium under licensing or contract arrangements. Although not all are currently approved for commercial sale, they are part of strategic supply chain contingency planning.

4. Regional and Emerging Suppliers
Emerging suppliers in Africa, India, and Southeast Asia are gradually developing the capability to produce cabotegravir sodium API. These local manufacturers, supported by international donors and public health agencies, aim to enhance supply security and reduce costs.

Regulatory and Quality Considerations
Suppliers must meet stringent quality standards mandated by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO). Gilead's APIs conform to these standards, ensuring safety, efficacy, and supply reliability. Licensed generic manufacturers are subject to these same regulatory stipulations, enhancing global supply stability.

Supply Chain Challenges
Despite the increasing number of suppliers, challenges persist including:

• Regulatory approvals: Navigating complex registration requirements across jurisdictions.
• Manufacturing scalability: Scaling API production to meet rising demand without compromising quality.
• Intellectual Property (IP) landscape: Patent protections can limit the entry of generics, although licensing agreements mitigate this in certain markets.
• Raw material sourcing: Securing high-quality raw materials amid global supply disruptions.

Future Outlook and Strategic Implications

Diversification of Suppliers
To mitigate risks, pharmaceutical companies and governments are fostering diversification of suppliers. Partnerships with emerging manufacturers leverage technology transfer and incentivize local API production, aligning with global health initiatives like the WHO’s Prequalification Program.

Generic Market Dynamics
The expiration of certain patents and licensing agreements opens pathways for generic manufacturers to enter the market, driving down prices and increasing global access. International organizations advocate for streamlined approval processes for generics to ensure timely availability.

Investment in Manufacturing Capacity
Increased investment in GMP-compliant manufacturing facilities in LMICs is pivotal. This approach reduces reliance on a few dominant players and boosts resilience against regional disruptions, exemplified by initiatives like the Clinton Health Access Initiative (CHAI).

Strategic Considerations for Stakeholders

• Pharmaceutical companies: Prioritize establishing diversified supplier networks and securing licensing agreements in key regions.
• Regulatory authorities: Facilitate accelerated approvals for quality-assured generics to expand access.
• Public health agencies: Support capacity-building initiatives in low-income regions, ensuring local API production.

Key Takeaways

• Gilead Sciences remains the primary supplier of cabotegravir sodium, leveraging proprietary manufacturing and extensive distribution channels.
• Licensing agreements with generic manufacturers are expanding the global supply base, especially in LMICs, mitigating supply risks and enhancing affordability.
• Contract manufacturing organizations play a critical role in supplementing supply but face regulatory and scaling challenges.
• Emerging regional suppliers are poised to increase global supply resilience, supported by international health initiatives.
• Diversification of suppliers, technology transfer, and regulatory streamlining are essential to meet the global demand for cabotegravir sodium.

FAQs

1. Who are the main global suppliers of cabotegravir sodium?
Gilead Sciences is the primary supplier worldwide, with licensed agreements with generic manufacturers in various regions. Several contract manufacturing organizations contribute to supply, primarily in Asia and Africa.

2. Are there generic versions of cabotegravir sodium available?
Yes, licensed generics are available in certain markets, especially where patent protections have expired or licensing agreements permit local manufacturing. These generics are subject to regulatory approval to ensure quality and safety.

3. What are the challenges in sourcing cabotegravir sodium API?
Challenges include regulatory hurdles, raw material procurement, manufacturing scaling, quality assurance, and IP restrictions. Supply disruptions can also arise from geopolitical tensions and global supply chain issues.

4. How is the demand for cabotegravir sodium expected to evolve?
Demand is expected to rise due to increased adoption of long-acting injectable HIV therapies, global initiatives to expand access, and potential new indications. This growth underscores the need for diversified and resilient supply chains.

5. What role do international organizations play in ensuring supply?
Organizations like WHO and UNICEF support licensing agreements, facilitate technology transfer, and assist in capacity-building to expand regional production. These efforts aim to enhance access and affordability worldwide.

Conclusion
The supply landscape for cabotegravir sodium is dynamic, characterized by dominant patent-holders, expanding licensed generic manufacturing, and emerging regional producers. Strategic partnerships, regulatory frameworks, and investments in manufacturing capacity are crucial to ensuring a stable, affordable supply that meets the increasing global demand for innovative HIV therapies.

Sources
[1] Gilead Sciences, Inc. – Product Information and Licensing Agreements
[2] World Health Organization (WHO) Prequalification Program Reports
[3] U.S. Food and Drug Administration (FDA) Public Records
[4] Clinton Health Access Initiative (CHAI) Reports on API Production
[5] Pharmaceutical Industry Market Analyses, 2022-2023