Rx-to-OTC Strategies: Maximizing the Commercial Potential of an Rx-to-OTC Switch  

With the growing cost of developing novel drugs, combined with the fact that fewer such drugs are gaining regulatory approval, the use of lifecycle management is playing an ever-more important role in the increasingly cost-conscious pharma industry. Rx-to-OTC switching is one such strategy employed to either enhance existing franchise revenues or protect branded revenues from generic competition.

For Rx-to-OTC switches to succeed, there needs to sufficient differentiation between the existing Rx drug and the new OTC product. However, differentiation must meet a genuine unmet need. Differentiation for the sake of it is unlikely to produce a winning Rx-to-OTC switch strategy.

The volume of the OTC market is declining in the majority of the seven major markets. If this trend continues, it will not only impact the profits of OTC manufacturers, but also national cost-containment measures to reduce ever-escalating healthcare costs.

At present, Rx-to-OTC switches in the five major EU markets are decided at a national level. However, despite ongoing discussions, there are numerous barriers to harmonized EU Rx-to-OTC switches. Consequently, it is unlikely that in the EU harmonization will happen at least in the foreseeable future.

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