Rx-to-Otc switches

How Does Your Company’s Rx-to-OTC Switch Pipeline Compare to Competitors?

Recently, there has been increased switch activity with the FDA exploring the use of new technology to aid consumers when making purchase decisions and using switch medications, as well as more applications being submitted by the pharmaceutical industry to the agency.

The recent approval of the Rx-to-OTC switch of Merck’s Oxytrol for Women OAB treatment after one advisory panel vote signals willingness on the part of the FDA to switch more products and create entirely new OTC categories. The FDA also approved the first nasal steroid for allergy treatment as an OTC with Sanofi’s Nasacort Allergy 24 Hour in October 2013, and this new brand was launched in February 2014. The proton pump inhibitor, Nexium 24 HR, was approved for switch in March 2014 and was launched by Pfizer in May 2014. However, an FDA Advisory Committee voted against the switch of Merck’s Singulair medication for allergy symptoms in adults in May 2014. Therefore, the switch horizon remains unpredictable and challenging to navigate.

Understanding how your company’s switch pipeline compares to competitors and learning about prescription drugs that have the potential to be in-licensed for future switch opportunities are crucial in order to tap into the high growth opportunities that exist with switches. Kline’s latest report in our highly regarded switch series, Rx-to-OTC Switch Pipelines USA: Competitive Assessment, allows your company to cast a wide net and understand what switch opportunities and threats exist for your company in the future. It is also meant to be used as a benchmarking tool to compare your company’s switch pipeline to that of competitors and understand how recent merger activity will change the switch landscape in the future.

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