Heart disease continues to be the primary cause of death , claimgloballying upwards of 17 million lives each year. Statins have evolved as an acceptable course for reducing LDL cholesterol and cardiovascular risk. Yet, a significant residual risk remains. With the increasing prevalence of obesity, diabetes, and metabolic syndrome, residual risk factors such as elevated triglycerides (TGs) and decreased HDL also rise. This situation commands a significant need and offers a lucrative market opportunity for innovative therapies targeting these risk factors.

A significant breakthrough is Vascepa, the ultra-pure EPAee (eicosapentaenoic acid ethyl ester, CAS No. 86227-47-6) medication. Cleared for lowering TGs in patients grappling with severe hypertriglyceridemia (TG ≥500mg/dL), it stands exclusively as the premier TG-lowering therapy demonstrating a 25% reduction in major adverse cardiovascular incidents.

Vascepa's exclusivity period is approaching its end. This presents a golden opportunity for generic variants to penetrate and leverage this proven, expanding market. Here's why we at Unibest believe that generic EPA epitomizes an undervalued blockbuster.

The market size of omega-3 prescription drugs estimated. Source: grandviewerresearch

    

Established Efficacy and Safety Profile, thanks to a Pioneering Reference Drug

The strenuous task of validating the efficacy and safety of EPA is already finished. A decade of data on Vascepa's sales and prescriptions reflects robust confidence among physicians in pure EPA for reducing TGs and enhancing cardiovascular outcomes. Generics can immediately harness this confidence instead of building awareness from ground zero.

Higher Purity Distinguishes EPA Generics from Conventional Fish Oil Products

The ultra-pure, 97%+ EPA formulations utilized in Vascepa boast several advantages over traditional, lower-purity fish oils:

- Increased potency with consistent dosing

- Elimination of saturated fats and contaminants that may negatively impact tolerability

- Avoidance of LDL increases sometimes witnessed with DHA-containing products

These benefits provide generics an edge against OTC Omega-3 supplements that physicians might hesitate to recommend otherwise.

Large Patient Pool with Availability Curtailed by Out-of-Pocket Costs

Nearly 1 in 3 Americans have high levels of TG. However, the price barrier limits Vascepa's adoption, thereby leaving a massive pool of patients that generics could service through affordable EPA treatment.

Unmet Need for Dedicated TG-Lowering Therapy

No other approved agents lower TGs as effectively as pure EPA. Statins, fibrates, and niacin primarily concentrate on other lipid markers. Additionally, fish oils are yet to be approved for high TG-level treatment. This absence of options paves the way for EPA generics to claim market share.