The importance of early planning The initial focus for new chemical entities (NCEs) being launched in the
pharmaceutical market is on the revenue that can be obtained during the years of patent protection and prescription-only sales. Patent expiry is inevitable and entirely predictable.
However, this is not a recommendation to ignore the next NCE, which is a major source of future revenue, but a recommendation not to abandon the existing drug, which can be worked synergistically with new drugs to obtain good continued RoI.
The key is to plan early. Ideally, planning should begin when the drug is first launched to enable a synergistic approach throughout the product lifecycle, including all its licensing phases, from prescription only (POM) through to pharmacy and over the counter (OTC) sales.
The financial management of an OTC drug is necessarily very different from a prescription-only medicine. Volume of sales is still an important factor, but now profit becomes more important. Ideally, this should be recognised internally within the organisation, by keeping the financials separate in order to be able to measure effectively and make sound decisions based on clear financial benefits.
Consider in the years (not the year) before patent expiry how to plan to manage the branding over the switch. Is a new brand appropriate for the OTC product? If not, does the existing brand need to be revitalised? Will a name be required? Will the same brand be used for both the prescription only form and the OTC form of the product?
done in some countries and may be beneficial for promotion as the OTC product may be advertised to the public
thus also supporting, indirectly, the prescription-only product. It is essential to begin the marketing plan early. For OTC medicines, a unique selling proposition (USP) is essential and, with regard to strap lines and claims, not
only do these need to be factually correct, but they also need to appeal to the consumer as having some significant
benefit over other, comparable products.
Linked into strap lines and claims is the summary of product characteristics and the marketing authorisation (MA). Will it be necessary to carry out new clinical trials to support the MA? If so, at what cost and with what effect on your RoI? If additional clinical trials are to be carried out, is there any possibility that these might also lead to new patentable discoveries or pose a risk if the study fails its primary endpoints or produces unexpected data?
Consider what competitors to the OTC product might already be in the market, despite the years of patent protection on the molecule itself. An alternative solution for the same condition using a different molecule can be a very real threat and, if already established in the generic market, may present commercial barriers to the launch of a new OTC product. Once again, the USP is key.
Having stressed the need for long-term planning, it is also worth noting the benefit of the period of exclusivity
following patent expiry. The usual 90-day exclusivity period might seem negligible, but consider the real timescales involved in bringing a new generic product to market.