Are You Ready for Loss of Exclusivity?

The life cycle of a prescription drug is well-known: It will be studied, submitted, approved, and – if warranted – launched. And then, one day, its patent will expire. But as a brand manager, you have options when faced with that inevitable loss of exclusivity (LOE). Even if LOE is years away, it’s never too soon to make a plan. 

Maybe developing and launching a generic or an over-the-counter version of the brand is the best way to maximize the molecule’s value. On the other hand, if you believe there’s enough equity in the brand, you might decide to keep supporting it with strong marketing efforts or leverage a life cycle management model like EVERSANA™ REIGNITE Commercialization to maximize your brand’s value and optimize revenue before its loss of exclusivity. You can also certainly choose to combine these strategies and do both. 

Will Patients Be Loyal? 
How do you know if your brand is likely to retain patients after LOE? If it has one or more of the following attributes in its favor, it’s a good bet that patients will stick with it: 

• Chronic – If a brand treats a chronic condition, which requires long-term management, it has the opportunity to build familiarity and comfort. 
• Symptomatic – If a brand treats a condition that is symptomatic, then it’s easier for patients to connect the brand with feeling better, strengthening their loyalty. 
• Lifestyle – If a patient takes a lifestyle drug, they’re probably actively choosing it (rather than being passively “required” to take it by their HCP). And, because it’s unlikely to be reimbursed, the patient is likely already choosing to pay full price for it. 
• Experience – If the brand has managed to create a unique emotional connection through a meaningful patient experience, it may find patients more willing to remain loyal. 
• Switching – If a brand treats a condition that has unusual barriers to switching between treatments, providers and patients will be less likely to attempt a switch. 

As you may have noticed, one of these things is not like the others. Pharma marketers can’t affect the inherent attributes of their brand. That’s chemistry, not marketing. But they can – and must – affect the emotional experience that patients (and other stakeholders) have with the brand. That’s marketing at its core. 

What’s a Pharma Marketer to Do? 
From preparation to execution, there’s much that can be done: 

• Knowledge – Understand your competition’s drug life cycles and strategies. 
  • You probably already have a good handle on the competitive landscape from having been in the market for some time, but it’s still worth taking a whole new look at the market in the context of LOE and pricing strategies.  

• Planning – Develop long-term projects that transcend life cycle stages. 
  • Differentiate your brand with solutions that inspire patients, professionals (and other stakeholders) with feelings of trust, knowledge, freedom and power. 

• Action – Address the “triple aim” with brand efforts that seek to improve the experience, health and cost for the patient. 
  • Remodeled dosages, delivery methods, or drug-device combinations can offer new and better solutions to patients. 
  • Co-pay offsets are often underutilized; awareness efforts can improve their use. 

Planning for loss of exclusivity should be done years, not months, ahead of time, so avoid the temptation to put it off for another day. By evaluating patient loyalty, understanding your competition, and differentiating your brand in the eyes of your “customers,” it’s possible to maximize value, even in the sunset years.