By John S. Sampalis, PhD

Loss of exclusivity to generics is in the life cycle of any brand drug. At that stage, the pharmaceutical company is faced with losing market shares and significant revenues. Pharmaceutical companies with brand drugs facing loss of exclusivity use several approaches to reduce the impact of the generic on the market. These strategies encompass the creation of legal barriers for generic companies, aggressive promotion aimed at discouraging the use of generics, development of strategic licensing arrangements, product modification and the introduction of their own generic or OTC versions of the patented drug.

Pharmaceutical companies are in some cases, able to restrain the loss of their market shares mainly by introducing a patented second generation of their initial brand drug or by authorizing a generic version of it. The first strategy consists in launching a second generation of the brand drug and to switch the patients from the first to the second drug generation prior the entry of the generic versions of the initial brand version. In the other approach, the pharmaceutical company, as the owner of a brand drug, licenses a third party to market a generic version of its own brand drug, called authorized generics. By introducing authorized generics during the exclusivity period, the pharmaceutical company can gather and secure shares from the generics market.

The conduct of clinical studies and the development of registries are additional powerful strategies that can moderate loss of market share. However, the effectiveness of these approaches in preserving product sales is often underestimated. In fact, maintaining ongoing clinical studies and registries in combination with traditional strategies could be the most effective approach when facing loss of exclusivity. Well-designed clinical studies (including phase IV clinical trials, post-marketing observational studies, surveys and chart reviews) provide evidence of real-life effectiveness that will reinforce cost-effectiveness and overall benefit positions of a first or second generation brand drugs. This will maintain familiarity and loyalty from physicians and patients thus reducing the erosions caused by the generics. In addition, the enrollment of patients in disease or treatment registries is an effective strategy to engage patients, physicians and pharmacists in the advancement of science and assessment of the long term benefit risk ratios with either a first or second generation of a brand drug. Long term studies are also essential in determining population based benefit risk ratios and identifying patient population that may have increase benefits from treatment or others that may be at increased risk for adverse events.

In conclusion, loss of exclusivity continues to represent an important threat to branded medications. However, the implementations of strategies that incorporate observational studies which advance knowledge and provide long term data could be used in reducing generic erosions but also to improve patient care.


Dr. John S. Sampalis
President
JSS Medical Research Inc.