Suppliers and packagers for EPZICOM

EPZICOM

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	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652	NDA	ViiV Healthcare Company	49702-206-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-206-13)	2010-10-12

Suppliers for the Pharmaceutical Drug EPZICOM: A Comprehensive Analysis

EPZICOM, a fixed-dose combination of abacavir and lamivudine, has played a significant role in HIV treatment since its approval in 2004. This report examines the supply chain dynamics surrounding EPZICOM, including its original manufacturer, generic suppliers, active pharmaceutical ingredient (API) providers, pricing strategies, patient assistance programs, and regulatory considerations. The analysis draws on regulatory filings, market data, and manufacturer announcements to provide a detailed overview of the ecosystem supporting this critical antiretroviral therapy.

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Historical Development and Original Manufacturer

ViiV Healthcare’s Role in EPZICOM’s Introduction

EPZICOM was developed and initially marketed by ViiV Healthcare, a joint venture between GlaxoSmithKline (GSK), Pfizer, and Shionogi[10]. The FDA approved EPZICOM in 2004 as a once-daily tablet combining abacavir (a nucleoside reverse transcriptase inhibitor) and lamivudine, simplifying treatment regimens for HIV patients[4]. ViiV Healthcare’s formation in 2009 consolidated HIV-focused research and commercialization efforts, with EPZICOM becoming part of a broader portfolio that included other combination therapies like Triumeq[10].

The original formulation’s discontinuation in March 2025 marked the end of brand-name EPZICOM, as generics had already dominated the market[5]. During its tenure, ViiV emphasized patient support through voucher programs and partnerships with healthcare providers to ensure access for uninsured or underinsured individuals[4].

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Generic Manufacturers and Market Entry

Lupin Pharmaceuticals’ Strategic Moves

Lupin Pharmaceuticals emerged as a key generic supplier, receiving tentative FDA approval for its abacavir/lamivudine tablets in November 2016[7][13]. The approval positioned Lupin’s product as an AB-rated generic equivalent, ensuring therapeutic equivalence to the brand-name drug. By leveraging its manufacturing facilities in Goa, India, Lupin aimed to capture a share of the U.S. HIV market, where EPZICOM had annual sales exceeding $400 million at the time[7][13]. Lupin’s entry underscored the growing role of Indian pharmaceutical companies in supplying affordable antiretrovirals globally.

Teva’s Expansion into HIV Generics

Teva Pharmaceutical Industries launched its generic version of EPZICOM in 2016, further intensifying competition[15]. Teva’s strategy focused on scaling production of high-quality generics while capitalizing on its established distribution networks. The company highlighted the importance of HIV therapeutics as a growth area, particularly in markets where cost constraints drove demand for affordable alternatives[15].

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Active Pharmaceutical Ingredient (API) Suppliers

Key Players in API Production

The synthesis of abacavir and lamivudine involves specialized chemical processes, with several manufacturers supplying APIs for generic EPZICOM. Hetero Drugs, Laurus Labs, and HRV Global Life Sciences are prominent suppliers listed on platforms like PharmaCompass[14][16]. These companies maintain Drug Master Files (DMF) with regulatory agencies, ensuring compliance with Good Manufacturing Practices (GMP)[14].

Vertical Integration and Quality Control

Many generic manufacturers, including Lupin and Teva, vertically integrate API production to reduce costs and mitigate supply chain risks. For example, Lupin’s in-house API capabilities enable tighter quality control and faster turnaround times for finished dosages[7]. This integration contrasts with smaller suppliers that may rely on third-party API procurement, introducing variability in pricing and availability[14].

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Pricing Dynamics and Patient Access Programs

Cost Comparison: Brand vs. Generic

As of 2025, the average wholesale price (AWP) for brand-name EPZICOM was approximately $1,550 per month, while generic versions cost between $448 and $1,395 monthly[1][6]. The disparity reflects generic competition’s impact on pricing, though logistical and regulatory costs still influence final retail prices.

Patient Assistance Initiatives

To address affordability challenges, organizations like the PAN Foundation and Rx Outreach offer copay assistance and subsidized pricing for eligible patients[6]. For example:

“Rx Outreach provides a 180-day supply of generic EPZICOM for $20 to low-income patients, ensuring continuity of care for vulnerable populations”[6].
These programs are critical in regions with high HIV prevalence and limited healthcare infrastructure.

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Regulatory and Safety Considerations

HLA-B*5701 Screening Mandate

A hallmark of EPZICOM’s safety profile is the requirement for *HLA-B5701 genetic testing* before initiation, as abacavir hypersensitivity reactions can be fatal[8]. Regulatory guidelines mandate that healthcare providers confirm negative HLA-B5701 status to minimize risks, a precaution upheld by both brand and generic manufacturers[8][12].

Bioequivalence and Regulatory Compliance

Generic suppliers must demonstrate bioequivalence to the reference product through studies like CAL10001, which compared EPZICOM’s pharmacokinetics to co-administered abacavir and lamivudine[4]. The FDA’s rigorous review process ensures that generics meet the same efficacy and safety standards as the original formulation[7][15].

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Market Impact and Future Trends

Shifts in HIV Treatment Paradigms

The introduction of integrase inhibitors like dolutegravir has reduced reliance on abacavir-based regimens in some regions[12]. However, EPZICOM’s generics remain a cost-effective backbone for combination therapies, particularly in resource-limited settings.

Competitive Landscape and Innovation

While generics dominate the abacavir/lamivudine market, ViiV Healthcare continues to innovate with next-generation combinations like dolutegravir/lamivudine[12]. This dual approach—legacy generics and novel formulations—ensures sustained access while advancing treatment efficacy.

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Conclusion

The supply chain for EPZICOM reflects broader trends in pharmaceutical manufacturing, from ViiV Healthcare’s pioneering role to the rise of generic suppliers like Lupin and Teva. API producers, patient assistance programs, and regulatory frameworks collectively ensure that this essential HIV therapy remains accessible. As treatment paradigms evolve, ongoing collaboration between manufacturers, regulators, and advocacy groups will be critical to addressing global HIV needs.

Key Insight:
“Generic competition has reduced EPZICOM’s cost by over 70%, yet patient assistance programs remain vital for equitable access”[6][15].

FAQs

1. Why was brand-name EPZICOM discontinued?
   ViiV Healthcare discontinued the brand in 2025 as generics dominated market share[5].

2. How do generics ensure quality compared to the brand?
   Generics undergo FDA bioequivalence testing to match the original drug’s safety and efficacy[7][15].

3. *What is the role of HLA-B5701 testing?**
   It identifies patients at risk for abacavir hypersensitivity, a potentially fatal reaction[8].

4. Which companies supply EPZICOM’s APIs?
   Hetero Drugs, Laurus Labs, and HRV Global Life Sciences are key suppliers[14][16].

5. Are there programs to help patients afford EPZICOM?
   Yes, organizations like Rx Outreach and PAN Foundation offer subsidies[6].

References

1. https://www.positivelyaware.com/drug-guides/hiv/epzicom-and-ziagen
2. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=080e3423-5962-4465-8e78-cd8793699336
3. https://www.goodrx.com/epzicom/what-is
4. https://www.eurekalert.org/news-releases/920887
5. https://www.drugs.com/availability/generic-epzicom.html
6. https://www.drugs.com/price-guide/epzicom
7. https://www.lupin.com/lupin-receives-tentative-approval-for-generic-epzicom-tablets/
8. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e0fc8605-1d64-41ab-af7e-bcf66a57c1fd
9. https://meddataservices.com/prescription-assistance-program/manufacturer-list/
10. https://en.wikipedia.org/wiki/ViiV_Healthcare
11. https://www.lupin.com/lupin-launches-generic-epzicom-tablets-in-the-us/
12. https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-announces-us-regulatory-submission-for-a-single-tablet-regimen-combining-dolutegravir-with-abacavir-and-lamivudine-for-people-living-with-hiv/
13. https://www.business-standard.com/article/markets/lupin-gains-on-tentative-approval-for-generic-epzicom-tablets-116112300300_1.html
14. https://www.pharmacompass.com/manufacturers-suppliers-exporters/epzicom
15. https://www.chemanager-online.com/en/news/teva-launches-generic-epzicom-tablets-us
16. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/epzicom