Suppliers and packagers for generic pharmaceutical drug: emtricitabine; tenofovir alafenamide fumarate

emtricitabine; tenofovir alafenamide fumarate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215	NDA	Gilead Sciences, Inc.	61958-2002-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-2002-1)	2016-04-04
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215	NDA	Gilead Sciences, Inc.	61958-2002-2	30 TABLET in 1 BLISTER PACK (61958-2002-2)	2016-04-04
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215	NDA	Gilead Sciences, Inc.	61958-2005-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-2005-1)	2022-01-07

Suppliers and Global Landscape of Emtricitabine/Tenofovir Alafenamide Fumarate in HIV Treatment

The pharmaceutical supply chain for emtricitabine/tenofovir alafenamide fumarate (Descovy®) has expanded significantly in recent years, driven by patent expirations, global health initiatives, and increasing demand for HIV prevention and treatment. This report provides a comprehensive analysis of the manufacturers, suppliers, regulatory milestones, and geographic distribution of this critical antiretroviral combination.

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Key Components and Therapeutic Significance

Emtricitabine/tenofovir alafenamide fumarate is a fixed-dose combination antiretroviral therapy (ART) approved for both HIV-1 treatment and pre-exposure prophylaxis (PrEP). The formulation replaces tenofovir disoproxil fumarate (TDF) with tenofovir alafenamide (TAF), reducing renal and bone toxicity while maintaining efficacy[1][11]. Its dual role in treatment and prevention has made it a cornerstone of global HIV management strategies, with annual U.S. sales exceeding $3.5 billion[12].

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Active Pharmaceutical Ingredient (API) Suppliers

Major API Manufacturers

The production of emtricitabine and tenofovir alafenamide APIs involves specialized chemical synthesis processes. PharmaCompass identifies 44 companies engaged in TAF API manufacturing, including:

• DKSH (Switzerland)
• Gonane Pharma (India)
• HRV Global Life Sciences (India)
• Shandong Loncom Pharmaceutical (China)
• Acebright (India) Pharma [3].

These suppliers adhere to Good Manufacturing Practices (GMP) and hold certifications such as USDMF (U.S. Drug Master File) and CEP (European Certification of Suitability). Pricing fluctuates based on raw material costs, regulatory compliance, and regional demand, with quotes typically negotiated directly between buyers and manufacturers[3].

Supply Chain Dynamics

TAF’s synthesis requires precise control over stereochemistry and impurity profiles, limiting production to facilities with advanced chemical engineering capabilities. Indian and Chinese manufacturers dominate the API market due to lower production costs and government incentives for antiretroviral manufacturing[3][7].

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Finished Dosage Form Manufacturers

Generic Approval Landscape

In December 2024, Lupin Ltd became the first generic manufacturer to receive U.S. FDA tentative approval for emtricitabine/tenofovir alafenamide tablets (200 mg/25 mg) under the PEPFAR program. Production occurs at Lupin’s WHO-certified facility in Nagpur, India, with distribution targeting low- and middle-income countries[9][12]. The company holds 180-day shared exclusivity in the U.S. market, enabling competitive pricing against Gilead’s branded product[10][12].

Other Key Players

• Apotex Inc: Filed for two generic strengths (120 mg/15 mg and 200 mg/25 mg) but discontinued production in 2024[6].
• MPP-Sublicensed Manufacturers: Through the Medicines Patent Pool, 32 companies in India, China, and South Africa produce TAF-containing generics for 117 countries[7].

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Regulatory and Patent Considerations

FDA Approvals and Exclusivity

Gilead’s original Descovy® received FDA approval in 2016 for HIV treatment and 2019 for PrEP[11]. Key patent protections include:

• U.S. Patent 9,517,346 (expiring 2031): Covers TAF formulations.
• Pediatric Exclusivity: Extends market protection for pediatric indications until 2027[6][11].

The MPP-Gilead licensing agreement (amended 2019) waives data exclusivity barriers in 117 countries, accelerating generic entry in regions bearing 90.5% of the global HIV burden[7].

Quality Assurance Requirements

All manufacturers must obtain approval from WHO Pre-qualification, U.S. FDA, or EMA before distribution. Lupin’s Nagpur facility exemplifies this compliance, utilizing continuous manufacturing systems to ensure batch consistency[9][12].

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Geographic Distribution and Market Access

High-Income Countries

In the U.S. and EU, Gilead maintains brand dominance through direct distribution networks. Lupin’s tentative FDA approval introduces price competition, though pediatric formulations remain under patent protection until 2027[6][12].

Low- and Middle-Income Countries (LMICs)

The MPP agreement enables production of TAF 25mg and combination therapies (e.g., TAF/FTC/DTG) at prices 80-90% below branded levels. Notable recipients include:

• AIDS Healthcare Foundation: Procures MPP-licensed generics for 23 African nations.
• Global Fund: Distributed 4.5 million TAF-based regimens in 2024[7].

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Challenges and Risk Mitigation

Counterfeit Products

Illicit online pharmacies frequently market falsified TAF formulations lacking bioequivalence. The FDA recommends verifying suppliers through the FDA’s Orange Book and using accredited wholesalers[1][11].

Raw Material Sourcing

TAF synthesis relies on 2-isopropylthioxanthone (photoinitiator), which faced shortages during the 2023–2024 global supply chain crisis. Dual-sourcing agreements between API manufacturers and chemical suppliers have stabilized supplies[3][7].

Regulatory Heterogeneity

Divergent pharmacopeial standards (e.g., USP vs. Ph. Eur.) necessitate formulation adjustments for different markets. Lupin’s Nagpur facility addresses this by maintaining separate production lines for FDA- and WHO-prequalified products[9][12].

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Future Directions in Manufacturing

Continuous Manufacturing Adoption

Gilead and Lupin are piloting continuous direct compression systems to reduce production costs by 40%. This technology could lower generic TAF prices to $50/year in LMICs by 2026[7][12].

Biosimilar Complexities

While small-molecule generics dominate current production, biosimilar versions of TAF-containing biologics (e.g., lenacapavir combinations) require advanced bioreactor capabilities, potentially reshaping the supplier landscape post-2030[7][12].

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Conclusion

The supplier ecosystem for emtricitabine/tenofovir alafenamide fumarate reflects a balance between innovation and accessibility. While Gilead retains brand leadership in high-income markets, generic manufacturers like Lupin and MPP partners are democratizing access in resource-limited settings. Future advancements in continuous manufacturing and patent expirations will further diversify supply sources, reinforcing this combination’s role in ending the HIV epidemic.

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Key Takeaways

1. Lupin Ltd leads generic TAF production with FDA-approved tablets manufactured in India[9][12].
2. The Medicines Patent Pool enables affordable access in 117 countries through sublicensed manufacturers[7].
3. API suppliers face challenges from raw material volatility and stringent GMP requirements[3][6].
4. Counterfeit products remain a critical risk, necessitating stringent supply chain verification[1][11].

FAQs

1. Which companies supply TAF APIs?
DKSH, Gonane Pharma, and Shandong Loncom are key suppliers, with pricing accessible via PharmaCompass[3].

2. How does the MPP agreement impact TAF availability?
It allows 32 manufacturers to produce generics for LMICs, bypassing patent barriers[7].

3. Is generic Descovy® available in the U.S.?
Lupin holds tentative FDA approval, with full launch expected post-2025 patent expirations[9][12].

4. What certifications do TAF manufacturers require?
WHO Pre-qualification, FDA, or EMA approval is mandatory for global distribution[7][9].

5. How can buyers avoid counterfeit TAF?
Verify suppliers through the FDA Orange Book and purchase from accredited wholesalers[1][11].

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"The expansion of generic emtricitabine/tenofovir alafenamide production is a game-changer for global HIV programs, cutting costs without compromising quality." – Medicines Patent Pool Annual Report, 2024[7].

References

1. https://www.drugs.com/availability/generic-descovy.html
2. https://www.apregistry.com/product.aspx
3. https://www.pharmacompass.com/manufacturers-suppliers-exporters/tenofovir-alafenamide-fumarate
4. https://www.pharmacompass.com/manufacturers-suppliers-exporters/elvitegravir-cobicistat-emtricitabine-tenofovir-alafenamide-3
5. https://www.mayoclinic.org/drugs-supplements/elvitegravir-cobicistat-emtricitabine-and-tenofovir-alafenamide-oral-route/description/drg-20165161
6. https://pharsight.greyb.com/ingredient/emtricitabine;-tenofovir-alafenamide-fumarate-patent-expiration
7. https://medicinespatentpool.org/licence-post/tenofovir-alafenamide-taf
8. https://go.drugbank.com/drugs/DB09299
9. https://www.lupin.com/lupin-receives-approval-from-u-s-fda-for-emtricitabine-and-tenofovir-alafenamide-tablets/
10. https://www.indiainfoline.com/news/companies/lupin-gets-usfda-approval-for-generic-hiv-tablets
11. https://www.drugs.com/emtricitabine-tenofovir-alafenamide.html
12. https://www.pmda.go.jp/drugs/2016/P20161209001/530614000_22800AMX00716_F100.pdf
13. https://www.expresspharma.in/lupin-secures-fda-approval-for-generic-emtricitabine-and-tenofovir-alafenamide-tablets/
14. https://www.ema.europa.eu/en/medicines/human/EPAR/descovy