Developing local promo strategies after Loss Of Exclusivity (LOE)

developing local promo strategies after loss of exclusivity

Pharma promotion in a highly competitive genericized market becomes more and more challenging. Today’s generic companies are not just manufacturers of cheap drugs but masters of their business, providing same or similar quality products at a lower price. Generic company management, very often with strong experience from the original/innovative drug industry, are implementing latest trends and thus make for LOE products much harder to keep up with good sales.

On top of this, local organizations are sometimes “left alone” to take care of brands that lost exclusivity 5 or more years ago, with several direct generic competitors and often new, advanced therapeutic options.

Innovative and original drug manufacturers start their blockbusters LOE plans early in the lifecycle, knowing that all the activities done during the exclusivity period are building Brand Equity and Patient Loyalty. The strength of Brand Equity and Patient Loyalty at the moment of LOE will determine the destiny of the original product after generic competition enters the market.


Global programs and strategies after LOE cover the needs of a local company for some time, at least 3-5 years, but what after that? What kind of programs and strategies can be developed locally to keep the sales at some satisfactory level, or at least to slow down sales decrease? And where can we make the difference? The commercial side of the business is already under pressure from the price decrease either as a legal obligation through internal/external price referencing, or the pressure that comes directly from the market.

On the other side, non-commercial approach gives more space for activities, and it is focused on Patients, in line with Patient centricity and Pharmaceutical care era we live in. This approach focuses on Patient Education and Activation and can be (if possible) prolongation of Patient Mobilization activities characteristic for pre-launch and Launch period.

Patient Mobilization

Patient Mobilization was developed at the beginning of the nineties in Europe as a “compensation” for the lack of Direct To Consumer campaigns. The European Council Directive 92/28/EEC “prohibits the advertising to the general public of medicinal products which are on medical prescription only.” but, “statements relating to human health or diseases, provided there is no reference, even indirectly, to medicinal products” are permitted.

This means that disease education is allowed so that new era of Consumer-directed campaigns (CDC) could start. Educating patients on disease and mobilizing them is a strategy that needs to be carefully planned, otherwise, you will end up increasing sales of the competitor product. That is why the Consumer-directed program is just one part of the strategy that is subtly connected to other two: Physician-directed and Pharmacy-directed part of the campaigns.

A successful Consumer-directed campaign delivers benefits to the brand sales, educating and mobilizing patients to talk to their doctor about treatment options, segmenting and targeting patients based on their profile and integrating consumer campaign to overall brand marketing.

Is there a life after LOE

Patient mobilization program is characteristic for pre-launch and launch period, especially for original drugs or novel treatment in the category (Lamisil and Detrusitol were among first drugs that had patient mobilization as an important part of the strategy, Viagra and Cialis both had mobilization campaigns, statins individually had own direct to consumer strategy, etc.). But, this is not the strategy to start using after LOE. If there was Patient Mobilization program developed before LOE, you can continue using it, modify it, align with new circumstances, modified marketing mix, focus on maintaining Brand equity and all this in line with new marketing budgets/sales expectations. But the question is, what local promo strategies after Loss Of Exclusivity you can develop, where to focus and how to determine if this is profitable or just creating expenses?

For a start, let’s go back on the patient journey, from the moment he or she experience first symptoms. This way we can provide patient support on each step and each dimension of the journey. In the digital era, even basic Patient Journey (Symptoms- HCP contact- Therapy) have multilayer offline/online dimension:

In order to find some unmet needs or those that are met but can be delivered in a more satisfactory way for the patient, we need to know the Jurney in much more details: who are our Patients in contact with, what is influencing their decisions and what are the emotions that model their total experience.

Human Care Systems created a concept called Complex Patient Journey with three main dimensions: Healthcare Journey/ Disease & Therapy Journey/ Human Journey:

 Each of these Journey dimensions has inflection points – moments or events where things can be changed dramatically in positive or negative directions. The more detailed Patient Journey you create, more you will know about inflection points to influence final patient experience positively, and toward your brand not toward the whole market.

Brand affinity, origins, and influences

Brand affinity is one of the main things any company consider when planning LOE strategy. Although Brand affinity is important for a global corporate decision on after-LOE strategy (strong affinity brands have OTC potential, low-affinity brands go for generic strategy or pure sunset), a checklist with 5 Drug Categories created by Deloitte Consulting is a tool that can be used when planning local promo strategies after Loss Of Exclusivity.

Chronic Conditions – Does our product treat the chronic condition?

This is the case when patients are using medicine for a longer period (than in case of acute conditions), so the company has the opportunity to develop stronger ties, familiarity, and comfort with the brand. Chronic conditions provide a pool of patients to retain, not only to acquire new (like in case of acute conditions). In local LOE Brand strategy, we need a program that will focus on retaining patients. If this program manages to acquire new patients, it will be an additional benefit, but no huge efforts should be put into this task.

Symptomatic Conditions – Is the underlying disease symptomatic?

If medicine relieves the patient from the symptoms (patient is feeling better), it builds confidence in the medicine and increases loyalty to the brand.

Again, local brand LOE strategy needs to work on retaining patients that already felt symptoms relief after using our drug, but in this case, the program needs to focus as well on acquiring new patients. Continuous education on disease and symptom relief, strong patient support and expert advocate should be base of local strategy.

Lifestyle Drug – Is our brand a lifestyle drug?

In the case of Lifestyle drug, you already have a patient with a conscious commitment to the brand, what you need to provide after LOE is the same level of service and even higher level of support and values to compensate higher price versus generics.

At the end of this checklist, there are two product groups: Unique Patient Experience and Therapeutic Area with Unique attributes, both already provide Uniqueness to be basic for generating brand affinity in the pre-LOE period. Local programs should be developed, when possible, to maximally use this uniqueness in the patient retention/acquisition.

A lot of to analyze and implement, but how to start?

All of the above-mentioned tools are used for new product launch planning, so what new we can learn from these for a mature product that already lost exclusivity? To answer this question, we need a poet, not just any poet, but Rudyard Kipling, the youngest Literature Nobel price laureate who was 42 years old when he was awarded back in 1907.

I have six honest serving men

They taught me all I knew

I call them What and Where and When

And How and Why and Who

5W1H – The Kipling questions or the Kipling Method

5W1H are questions whose answers are considered basic in information-gathering and Project management. Example of how to use 5W1H when planning local LOE strategy/ patient education & support program is below:

WHY – although looks obvious, it is important to know why are we doing this. Define the goals, quantitative and qualitative, and the way to measure it. WHY is as well important question to answer before approaching participants (KOLs, educators, Patient groups or individuals), to explain WHY would they join our program;

WHO – Identify participants in the program, draw connections between them and try to predict influences and possible changes/inflection points;

WHAT – Create a hierarchy of events in the program as well as a detailed timeline. Connect these with WHY, especially measurement part, and WHO – to describe (to yourself) relationships and influences;

WHERE – Identify all the channels of communication to be used in the program and link these to event list created in WHAT and list of participants created in WHO;

WHEN – Detailed timeline linked to specific targets. Describes the way program will flow as well as phases of education and participant inclusion (different groups/individuals);

HOW – When you have clear answers to all 5W questions, create a tactical plan HOW to do it.


Which activities to continue from the pre-LOE period and what can we add as new activities and programs after LOE, depends on figures from one deep ROI analyses, the heritage of pre-LOE programs/strategies and competitive landscape in the new, generic market.

Sometimes brand means so much to us that we have really hard time to let go but at the end…

Leave a Reply