As competitive pressure from the post-patent-expiry entry of generics and new brands onto the market mounts, drug product lifecycles are becoming shorter and shorter with lower peak sales – a double edged sword for pharmaceutical companies. In fact, products worth more than $100 billion in sales (1) will be going off-patent and subject to generic incursion between 2008 and 2012. Thus, effective lifecycle management is becoming a must for pharma companies looking to maximize the return on their considerable investment.

However, it is becoming increasingly difficult for pharma companies to do so with their current lifecycle management strategies. With the growing pressures of cost containment, only those strategies that satisfy payers, physicians and patients by meeting a true unmet therapeutic need will ultimately be successful in the future. Consequently, the development of reformulation and fixed dose combination products will become less and less popular strategies as success becomes more difficult to achieve.

Product lifecycles are becoming shorter for a number of reasons, a situation that is compounded by a dearth of new products needed to replace lost revenues. Thus lifecycle management strategies that prolong the patent-protected life of a drug have been propelled to the top of the agenda for many brand managers.

While strategies such as the development of reformulation products have been successful in the past, growing payer scrutiny is limiting their success under current market dynamics. Only those products offering significant improvement over the original therapy in terms of not only patient compliance and convenience, but also therapeutic outcomes are likely to receive desired pricing and reimbursement terms.

However, not all markets are the same. In countries with less mature generics markets, such as France, Italy and Spain, there is a greater opportunity for traditional developmental lifecycle management strategies to succeed: with lower generic erosion post-patent expiry and general physician and patient distrust of generics, reformulations and fixed dose combination drugs are much more likely to achieve high uptake than in the UK and Germany.

While the US has generally been the prime market for the launch of reformulated products, payers are increasingly looking to cut costs and physicians are becoming more cynical regarding the advantages such line extensions bring to patients. Consequently, reformulated products are finding it harder to achieve higher uptake, and with the drop after cheaper generics enter the market resulting from patients being switched onto generics, the impact they have on protecting brand franchise sales is diminishing.

Related reasearch: Optimizing Brand Lifecycle Management