COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100	NDA	Gilead Sciences, Inc.	61958-1201-1	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1201-1)	2012-08-27
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for antiretroviral drugs—specifically cobicistat, elvitegravir, emtricitabine, and tenofovir disoproxil fumarate (TDF)—is characterized by a complex supply chain involving multiple global manufacturers. These agents form the core components of combination therapies for HIV treatment. Ensuring consistent, high-quality supply is essential for healthcare providers and pharmaceutical companies investing in HIV management. This analysis details the current key suppliers, their manufacturing footprints, and the implications for market stakeholders.

Cobicistat: Key Suppliers

Cobicistat functions as a pharmacoenhancer in ART regimens, boosting the efficacy of drugs such as elvitegravir. Developed originally by Gilead Sciences, cobicistat's manufacturing is primarily centralized.

Gilead Sciences
As the pioneer and patent holder, Gilead is the sole supplier of branded cobicistat. The company's manufacturing facilities are located in the United States and Ireland, adhering to stringent Good Manufacturing Practice (GMP) standards. Gilead controls the entire supply chain, but licensing agreements have expanded access to generic manufacturers in certain markets.
Generic Manufacturers
Although Gilead holds exclusive rights in many regions, generic production has emerged in countries like India and China, facilitated by local pharmaceutical firms with licensing agreements or through patent expiration after the product's market exclusivity period. Notable players include:
- Hetero Drugs (India)
- Mylan (now Viatris) (India)
- Zydus Cadila (India)
  These manufacturers utilize APIs sourced globally but often produce active ingredients locally under licenses, addressing supply needs in low- and middle-income countries.

Elvitegravir: Key Suppliers

Elvitegravir, supplied primarily by Gilead Sciences, is an integral integrase inhibitor component of several fixed-dose combinations.

Gilead Sciences
Gilead holds patent rights and is the principal manufacturer of elvitegravir. Its manufacturing sites are accessed by supply chain partners in Asia and Europe to meet global demand, with quality control maintained through strict regulatory oversight.
Generic Manufacturers
Since patent expiration or licensing agreements, generic producers have entered the space:
- Zydus Cadila (India)
- Hetero Drugs (India)
  These firms produce active pharmaceutical ingredients (APIs) and finished formulations for regional markets, especially in Africa, Asia, and Latin America.

Emtricitabine: Key Suppliers

Emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI), has multiple manufacturers, reflecting a fragmented supply landscape driven by patent status and regional manufacturing policies.

Gilead Sciences
The original patent holder, Gilead, manufactures and supplies emtricitabine primarily through its own facilities. Gilead's manufacturing units are located in the US and Ireland, with a focus on high-quality standards.
Generic Manufacturers
Following patent expiry in many regions, a broad array of manufacturers supply generic emtricitabine, including:
- Hetero Drugs (India)
- Cipla (India)
- Mylan (Viatris) (India)
- Sun Pharmaceutical Industries (India)
  These companies produce APIs and finished drug products for global markets, with India being a major supplier.

Tenofovir Disoproxil Fumarate (TDF): Key Suppliers

TDF is a cornerstone nucleoside analog reverse transcriptase inhibitor, with multiple suppliers owing to its patent status and production complexity.

Gilead Sciences
Gilead is the original developer and dominant global supplier of TDF, with manufacturing facilities primarily located in the US and Ireland.
Generics Manufacturers
Generic versions of TDF became widely available post-patent expiry, led by:
- Hetero Drugs (India)
- Cipla (India)
- Fresenius Kabi (Germany)
- Aurobindo Pharma (India)
  These firms source APIs from various regions, including China and India, and produce formulations for low- and middle-income countries.
API Supply Chain
Major raw material suppliers include Chinese API manufacturers, who produce key intermediates and APIs for both branded and generic TDF.

Manufacturing and Supply Chain Dynamics

The supply of these HIV drugs hinges on a combination of patent protections, licensing agreements, and regional manufacturing capabilities.

Patent and Licensing Impact
Gilead holds patents for cobicistat, elvitegravir, and TDF in many jurisdictions, influencing the control of manufacturing and licensing. License agreements with Indian and Chinese producers have enabled broader access in developing countries.
Regional Manufacturing Hubs
India dominates global generic production for these compounds, leveraging its robust pharmaceutical industry and API manufacturing capabilities. China also plays a pivotal role as an API supplier, especially for TDF intermediates.
Quality and Regulatory Considerations
Regulatory agencies such as the US FDA, EMA, and WHO prequalify many facilities, ensuring product safety and efficacy. International organizations increasingly scrutinize generic suppliers to ensure consistent quality.

Market Implications and Future Trends

The evolving patent landscape and increasing generic competition have enhanced supply security, lowered prices, and expanded access, especially in underserved markets. However, supply chain disruptions remain a concern due to geopolitical issues, API shortages, and regulatory challenges.

Ongoing development of novel formulations, biosimilars, and patent expirations will continue to reshape supplier dynamics. Strategic collaborations and licensing agreements are likely to facilitate broader access, particularly for complex molecules like cobicistat and elvitegravir.

Key Takeaways

Gilead Sciences remains the primary supplier for patented formulations of cobicistat, elvitegravir, emtricitabine, and TDF, with manufacturing concentrated in North America and Europe.
Indian pharmaceutical firms such as Hetero, Cipla, and Sun Pharma are major generic suppliers post-patent expiry, supplying APIs and finished products globally.
China serves as a critical API supplier, especially for TDF intermediates, influencing overall supply chain resilience.
Licensing agreements have broadened access to generics, improving affordability and availability in emerging markets.
Supply stability depends on regulatory compliance, geopolitical stability, and adaptive manufacturing strategies.

FAQs

1. Who are the leading suppliers of cobicistat globally?
Gilead Sciences is the exclusive supplier of branded cobicistat worldwide; however, licensed generic manufacturers like Hetero, Viatris (formerly Mylan), and Zydus Cadila produce generic versions primarily for markets in India and Africa.

2. Can generic companies produce elvitegravir and TDF?
Yes, following patent expirations, numerous Indian and Chinese manufacturers produce generic elvitegravir and TDF, expanding access in low- and middle-income countries.

3. Are there concerns about the quality of generic antiretroviral drugs?
Most generic manufacturers comply with WHO prequalification standards and local regulatory approvals. However, variability exists, underscoring the importance of sourcing from approved facilities.

4. How does patent status influence supply chain dynamics?
Patents confer exclusive manufacturing rights, limiting generic production until expiry or licensing agreements are in place. This impacts prices, availability, and regional access.

5. What is the outlook for future supply of these drugs?
Patent expirations, evolving licensing agreements, and advancements in manufacturing technologies will continue to diversify suppliers and enhance supply stability, although geopolitical and regulatory factors may affect this trajectory.

Sources

[1] Gilead Sciences Official Website: HIV & Antiretroviral Drugs Portfolio
[2] WHO Prequalification Programme, Generic HIV/AIDS Medicines List
[3] Indian Pharmacopoeia Commission Reports on API Manufacturing
[4] Patent Status and Market Data for HIV Antiretrovirals (2015–2023)
[5] Regulatory Bodies: US FDA Approved Drug Master Files and EMA Approvals

Suppliers and packagers for generic pharmaceutical drug: COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE