COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455	NDA	Janssen Products LP	59676-800-30	30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30)	2018-07-17
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455	NDA	Janssen Products LP	59676-800-99	30 TABLET, FILM COATED in 1 BOTTLE (59676-800-99)	2018-07-17
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The pharmaceuticals cobicistat, darunavir, emtricitabine, and tenofovir alafenamide fumarate (TAF) are critical components in antiretroviral therapy (ART) for managing HIV/AIDS. Securing reliable suppliers is essential for pharmaceutical companies, healthcare providers, and global health initiatives to ensure drug availability, affordability, and quality. This analysis provides an overview of key suppliers for these drugs, highlighting manufacturing capacities, geographic distribution, and market dynamics.

Cobicistat Suppliers

Cobicistat acts as a pharmacokinetic enhancer, boosting the efficacy of other antiretroviral agents by inhibiting CYP3A enzymes. It is primarily marketed as Tybost by Gilead Sciences.

Gilead Sciences: The original and most prominent supplier, Gilead manufactures cobicistat in-house, ensuring high-quality standards aligned with regulatory requirements (FDA, EMA). Gilead maintains global manufacturing facilities, including in the United States and Ireland.
Contract Manufacturing Organizations (CMOs): Several CMOs such as CME (China-based), Fujifilm Diosynth Biotechnologies, and Novartis have capacity for cobicistat production under licensing agreements, expanding supply sources.
Emerging suppliers: Due to patent expiry and increased demand, generic manufacturers in India (e.g., Hetero Drugs, Mylan, Cipla) have developed cobicistat APIs following process approval, potentially broadening supply in the near future, albeit pending regulatory approvals.

Darunavir Suppliers

Darunavir, marketed as Prezista by Janssen Pharmaceuticals, is a protease inhibitor crucial for treating HIV.

Janssen Pharmaceuticals: As the originator, Janssen controls major manufacturing facilities globally, including in Belgium, Puerto Rico, and India.
Generic manufacturers: Post patent expiry in various jurisdictions, Indian companies such as Cipla, Lupin, Aurobindo Pharma, and Hetero Drugs have scaled up production of darunavir APIs and finished products.
Contract manufacturers: CMOs like Sidley Holdings, Mundipharma, and Fujifilm facilitate capacity expansion, especially in Asia and Europe.
Market dynamics: Growing demand from developing countries has incentivized numerous generics firms to establish GMP-compliant production, contributing to price competitiveness.

Emtricitabine Suppliers

Emtricitabine (FTC), marketed as Emtriva, plays a pivotal role in combination ART regimens.

Gilead Sciences: As the original developer, Gilead supplies the bulk of the global market from manufacturing plants in the US, Singapore, and China.
Key generic producers: Indian pharmaceutical companies such as Cipla, Lupin, Aurobindo, and Hetero have established robust supply chains post-patent expiration, producing APIs and formulations.
Manufacturing capacity: These firms have invested heavily in GMP certification and process optimization, supporting global supply especially in low- and middle-income countries (LMICs).
Supply chain considerations: Geopolitical factors, patent litigations, and regulatory approvals influence the distribution and availability of generics.

Tenofovir Alafenamide Fumarate (TAF) Suppliers

TAF is a newer prodrug of tenofovir, notable for its improved safety profile over tenofovir disoproxil fumarate (TDF). It is marketed under brand names like Vemlidy (Gilead) and integrated in multiple fixed-dose combinations.

Gilead Sciences: As the innovator, Gilead is the primary manufacturer of TAF with manufacturing sites in the US and Ireland, adhering to strict quality standards.
Generic manufacturers: Since patent expiry in key markets (e.g., India, Africa), firms such as Cipla, Aurobindo, Hetero, and Mylan have developed TAF APIs and formulations.
API production: The synthesis of TAF is complex, requiring advanced chemical processes, limiting the number of qualified suppliers. However, Asian API manufacturers have made significant advances, securing a supply chain.
Regional suppliers: China-based companies like Shanghai HoPhar and Yunnan Baiyao have emerged as potential TAF API suppliers, though regulatory approval varies.

Market and Supply Chain Considerations

Patent Expirations and Impact on Suppliers

The expiration of patents for many of these drugs, notably emtricitabine and TAF, has led to increased generic manufacturing, diversifying the supplier base and reducing costs.
Conversely, drugs still under patent protection, such as cobicistat and darunavir (in certain jurisdictions), limit supply to originators or authorized generics.

Geographic Concentration and Risks

Reliance on Asian manufacturers, especially India and China, constitutes a significant portion of the supply chain, presenting risks related to geopolitical stability, regulatory harmonization, and capacity constraints.
Efforts to diversify supply sources include partnerships with CMOs in Europe, North America, and Africa.

Quality Assurance and Regulatory Compliance

Suppliers must meet stringent Good Manufacturing Practice (GMP) standards. Regulatory authorities, including the FDA and EMA, conduct audits to ensure compliance.
The proliferation of generics has increased concerns over quality, prompting ongoing surveillance and post-market monitoring.

Emerging Trends and Strategic Considerations

Scaling of generic API production: As global demand for ART rises, particularly in LMICs, manufacturing capacity is expanding, with focus on cost-effective, high-quality APIs.
Supply chain resilience: Companies are adopting multiple sourcing strategies, maintaining buffer stocks, and investing in local manufacturing to mitigate geopolitical risks.
Innovation and biosimilar development: Research into novel prodrugs and biosimilars may alter supplier dynamics over the next decade.

Key Takeaways

Market dominance: Gilead Sciences remains the primary supplier for cobicistat and TAF, maintaining control over manufacturing quality and regulatory compliance.
Generics expansion: Indian pharmaceutical companies are the main producers of APIs for darunavir and emtricitabine, with growing capabilities in TAF synthesis post-patent expiry.
Supply chain diversification: To mitigate risks, stakeholders are forging new partnerships with CMOs and regional manufacturers, especially in Asia and Africa.
Regulatory oversight: Ensuring supplier quality remains critical; suppliers must adhere to rigorous GMP standards to sustain global supply chains.
Pricing and accessibility: Increased competition from generics has contributed to downward pressure on prices, enhancing access in LMICs and facilitating global HIV/AIDS management.

FAQs

1. Who are the main suppliers of cobicistat globally?
Gilead Sciences is the principal supplier, manufacturing cobicistat in-house. Several CMOs, including those in China and Europe, also produce it under licensing agreements, with emerging generics from Indian companies due to patent expiry.

2. Are there reliable generic suppliers for darunavir?
Yes. Major Indian pharmaceutical companies like Cipla, Lupin, and Hetero have developed GMP-compliant API and finished product manufacturing capabilities, especially following patent expiration in key markets.

3. How does the supply chain for emtricitabine compare globally?
Emtricitabine's supply chain is dominated by Indian generics, with key manufacturers holding substantial capacity and market share due to affordable APIs and established distribution networks.

4. What are the challenges related to TAF supply?
TAF's complex synthesis limits the number of qualified API suppliers. While Gilead controls most production, new generic manufacturing in India and China is emerging, driven by patent expirations, but regulatory approval remains a hurdle.

5. How do geopolitical factors impact these drug supplies?
Heavy reliance on Asian manufacturing centers exposes supply chains to geopolitical risks, trade tensions, and disruptions, emphasizing the need for diversification and local manufacturing strategies.

Sources
[1] Gilead Sciences Official Website. "Tybost (cobicistat)"
[2] Janssen Pharmaceuticals. "Prezista (darunavir)"
[3] Indian Pharmaceutical Market Reports. "Generic APIs for HIV drugs"
[4] World Health Organization (WHO). "Global procurement of antiretroviral drugs"
[5] US Food and Drug Administration (FDA). "GMP requirements for pharmaceutical manufacturing"

Suppliers and packagers for generic pharmaceutical drug: COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE