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Loss of exclusivity (LOE) doesn’t have to spell doom for branded drug revenue streams. In the face of impending patent expirations, pharmaceutical companies can adopt key approaches to preserve meaningful value well into the post-patent-loss future.
Traditionally, LOE has led to a sharp decline in sales for small molecule drugs, with brand unit share falling to a mere 16% within a year of generics hitting the market. However, there are ways to counteract this impact and maintain revenue opportunities.
To safeguard value after LOE, companies can employ three effective strategies:
1. Preserve Brand Equity and Patient Loyalty: By shifting focus from core marketing and sales activities before LOE to patient retention efforts, companies can extend sales momentum. Creating enrollment programs and copay cards to drive patient acquisition and reduce out-of-pocket expenses can help maintain sales volume and reduce profit erosion.
2. Create an Over-the-Counter (OTC) Formulation: Developing an OTC version of the branded product can help maintain and grow volume post-LOE. This strategy allows access to a broader patient base, decelerating value erosion and eliminating reimbursement hurdles.
3. Launch a Generic: Surprisingly, a branded drug company can directly profit from patients who opt for a generic alternative. Offering a branded generic, authorized generic, or licensed generic allows the company to retain a higher portion of product value with relatively low implementation costs.
It is important to consider the level of brand affinity, as it guides decision-making on which strategy to adopt. Additionally, careful planning is vital, with preparations ideally starting two years before the anticipated LOE date.
Loss of exclusivity doesn’t have to be the end for pharmaceutical products. With strategic planning and innovative approaches, companies can maximize product value and revenue well into the future.