Suppliers and packagers for generic pharmaceutical drug: DOLUTEGRAVIR SODIUM; LAMIVUDINE

DOLUTEGRAVIR SODIUM; LAMIVUDINE

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	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994	NDA	ViiV Healthcare Company	49702-246-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-246-13)	2019-04-08
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994	NDA	ViiV Healthcare Company	49702-246-33	1 BLISTER PACK in 1 CARTON (49702-246-33) / 30 TABLET, FILM COATED in 1 BLISTER PACK	2019-04-08
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994	NDA	ViiV Healthcare Company	49702-246-62	1 BLISTER PACK in 1 CARTON (49702-246-62) / 14 TABLET, FILM COATED in 1 BLISTER PACK	2019-04-08

Suppliers for the Pharmaceutical Drugs: Dolutegravir Sodium and Lamivudine

Last updated: July 29, 2025

Introduction

Dolutegravir sodium and lamivudine are critical antiretroviral agents used extensively in the management of HIV/AIDS. Their global demand has driven a complex supply chain involving numerous manufacturers spanning multiple continents. This analysis provides a comprehensive overview of the key suppliers for these drugs, highlighting their manufacturing capacities, geographic distribution, regulatory status, and market influence. Understanding these suppliers' landscape is essential for stakeholders involved in procurement, licensing, and strategic planning within the pharmaceutical sector.

Overview of Dolutegravir Sodium and Lamivudine

Dolutegravir sodium (DTG) is an integrase strand transfer inhibitor (INSTI), known for its high potency, favorable tolerability, and low resistance barrier [1]. Lamivudine, a nucleoside reverse transcriptase inhibitor (NRTI), is widely used in combination therapy due to its efficacy and safety profile [2]. Both drugs are often co-formulated to produce fixed-dose combinations (FDCs), simplifying treatment regimens.

Major Global Suppliers

1. Mylan (Viatris)

• Geographic Footprint: Mylan, now part of Viatris, operates manufacturing facilities across India, the Philippines, and the U.S. [3].
• Product Portfolio: One of the leading generic manufacturers for both dolutegravir and lamivudine, supplying to global markets, including emerging economies and developed regions.
• Market Share and Capabilities: Mylan’s advanced manufacturing facilities meet stringent WHO prequalification and USFDA standards, enabling large-scale production of active pharmaceutical ingredients (APIs) and finished formulations.

2. Hetero Labs

• Location: India
• Strengths: Hetero is a major producer of APIs and dosage forms for HIV and other viral diseases.
• Regulatory Status: Their facilities have achieved WHO prequalification, facilitating procurement by global health agencies [4].

3. Sun Pharmaceutical Industries

• Manufacturing Sites: Multiple facilities in India
• Market Role: Supplies generic versions of lamivudine and is involved in API production for dolutegravir. They benefit from scale and robust R&D capabilities.

4. Zydus Cadila

• Location: India
• Contributions: Supplies both APIs and fixed-dose combinations, with a focus on affordability and accessibility in developing countries.

5. Cipla

• Geographic Reach: India, South Africa, and other emerging markets
• Specialization: Known for pioneering affordable HIV therapies, Cipla produces both lamivudine and dolutegravir APIs and formulations [5].

6. Apotex

• Base: Canada, with significant manufacturing presence in India
• Market Impact: Supplies generic versions globally, including the U.S. and Europe.

7. Viatris (formerly Mylan and Pfizer assets)

• Scope: As a consolidated entity, Viatris provides substantial API and FDC supplies for HIV treatment, including dolutegravir-based medications.

8. Global Health Initiatives and Contract Manufacturers

Agencies like the WHO’s Prequalification Program and the Medicines Patent Pool (MPP) facilitate access to quality-assured generics, often working with multiple contract manufacturers and smaller producers to expand supply [6].

Manufacturing Capacity and Quality Considerations

The supply chain's resilience hinges on manufacturing capacity, compliance with Good Manufacturing Practices (GMP), and regulatory approvals. Indian firms dominate API production, benefiting from a competitive cost structure and global demand. Certifications from WHO prequalification and USFDA approval significantly influence a supplier’s market access and credibility. The COVID-19 pandemic underscored the importance of diversified sourcing, prompting many manufacturers to scale up API production and establish local manufacturing hubs in Africa and Asia.

Regulatory and Patent Landscape

While many suppliers operate under voluntary licensing agreements with patent holders or participate in patent pools to enable generic manufacturing, patent protection status varies globally. The Patent Status of dolutegravir and lamivudine has often been challenged or negotiated to improve access in low- and middle-income countries [7]. Binding agreements, national regulations, and TRIPS flexibilities influence the supplier landscape and availability.

Emerging Suppliers and Market Dynamics

Increasing focus on biosimilars or newer antiretroviral agents may impact market shares of established suppliers over the next decade. However, the entrenched presence of Indian generic manufacturers ensures continued supply of affordable, high-quality dolutegravir sodium and lamivudine. The expansion of manufacturing capacity and ongoing negotiations for licensing foster a more competitive and resilient supply environment.

Market Participants in Different Regions

• Africa: Reliance on Indian generic manufacturers like Mylan, Cipla, and Hetero, supported by global health programs.
• Asia: Predominantly Indian companies, with emerging Chinese firms gradually entering.
• North America/Europe: Larger pharmaceutical companies such as Viatris (formerly Mylan) and Apotex dominate, primarily supplying highly regulated markets.
• Latin America: Local licensing partnerships facilitate broader access; suppliers like Zydus also play a role.

Supply Chain Challenges and Opportunities

Price fluctuations, regulatory delays, and geopolitical factors can disrupt supply. Conversely, initiatives like the MPP and WHO prequalification programs enable rapid scaling and quality assurance. Building strategic stockpiles, encouraging local API manufacturing, and fostering licensing agreements are vital strategies for sustainable supply.

Conclusion

The territory of suppliers for dolutegravir sodium and lamivudine remains concentrated yet diverse, predominantly anchored by Indian generic manufacturers with global reach. Continuous investments in manufacturing capacity, adherence to regulatory standards, and strategic partnerships underpin the resilience of this supply chain. The increasing participation of organizations like the Medicines Patent Pool enhances market competition, ensuring sustained access to these essential HIV medications.

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Key Takeaways

• Indian pharmaceutical companies such as Mylan, Hetero, Cipla, and Zydus dominate the API and formulation supply chain for dolutegravir sodium and lamivudine, supported by regulatory prequalification and licensing.
• Global health initiatives and patent pools underpin access, facilitating manufacturing and distribution in low-income regions.
• Supply chain resilience depends on diversified manufacturing, quality compliance, and strategic licensing agreements.
• Market dynamics are influenced by patent statuses, regulatory environments, and evolving treatment guidelines, requiring continuous monitoring.
• Enhancing local API manufacturing capacities and fostering international cooperation will be critical for future supply stability.

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FAQs

1. Who are the leading global suppliers of dolutegravir sodium and lamivudine?

The primary suppliers include Indian pharmaceutical giants such as Mylan (Viatris), Hetero Labs, Cipla, Zydus Cadila, and Sun Pharmaceutical Industries, supported by companies like Apotex and regional manufacturing organizations globally.

2. What regulatory certifications are essential for these suppliers?

WHO Prequalification and USFDA approval are critical for international procurement, especially for drugs supplied to global health agencies and low-resource settings.

3. How do patent protections affect the supply of these drugs?

Patent protections can limit generic manufacturing; however, licensing agreements, patent pools, and TRIPS flexibilities enable generic production and market access in many regions.

4. Are there regional differences in suppliers for these drugs?

Yes, Indian companies supply a substantial portion globally, with North American and European markets dominated by companies like Viatris and Apotex, supported by local licensing and manufacturing.

5. What initiatives are improving the supply chain's resilience?

Programs like the WHO Prequalification, the Medicines Patent Pool, and voluntary licensing agreements, combined with expanding local API manufacturing capacities, enhance supply stability and affordability.

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References

[1] WHO. (2022). Global HIV/AIDS statistics.

[2] U.S. Food & Drug Administration. (2021). HIV Drugs Overview.

[3] Viatris Corporate Reports. (2023). Annual Manufacturing and Supply Chain Overview.

[4] Hetero Group. (2022). WHO Prequalification Achievements.

[5] Cipla Annual Report. (2023). Product Portfolio and Market Data.

[6] Medicines Patent Pool. (2022). Annual Report on Licensing and Access.

[7] World Intellectual Property Organization. (2022). Patent Landscape for Antiretroviral Drugs.