With the publication of FDA’s NSURE (Nonprescription Safe Use Regulatory Extension) in February 2012, the pharmaceutical industry has been buzzing with potential for new switches, using unique approaches and technology to support the approval of new switches and safe use of consumer OTC medications.
“There is excitement and new Rx-to-OTC switch possibilities being evaluated in the United States like we have not seen in years,” says Laura Mahecha, Industry Manager, Healthcare. “Kline has been analyzing and forecasting switches for decades. Our most recent research, Rx-to-OTC Switch Pipelines USA: Competitive Assessment, has shown that we are at a crossroads where the industry is cautiously optimistic that new switches with real commercial potential will become a reality,” she adds.
In some cases, Rx-to-OTC switches would create brand new classes of OTC medications, such as erectile dysfunction, migraine, and cholesterol reducing medications. Other switches are being considered in existing classes; however, medications that may have lost patent protection years before are now being switched because they represent an improvement in OTC treatment options available to consumers. One example of this is GlaxoSmithKline’s Flonase Allergy Relief, which lost prescription patent protection several years ago, but was approved for Rx-to-OTC switch in July 2014 and has recently been launched on the OTC market.
There is some trepidation on brand new switches gaining approval, as a new team is in place at the FDA’s Office of Nonprescription Drugs including Theresa Michele, MD, the FDA’s Director, Division of Nonprescription Clinical Evaluation as of late 2014. “Whenever there is a new team in place at the FDA, the agency tends to be rather conservative and the pharmaceutical industry needs to understand their regulatory concerns and help overcome such concerns with their switch applications and Advisory Committee meetings,” says Mahecha.
There are also several medications that are made by purely prescription pharmaceutical companies that have switch potential, which could be lucrative in-licensing opportunities for companies with switch experience and OTC marketing prowess.
To learn more about the Rx-to-OTC switch opportunities, refer to Kline’s soon-to-be-published Rx-to-OTC Switch Pipelines USA: Competitive Assessment. This report will provide subscribers with an objective assessment of Rx-to-OTC switch pipelines by company in the United States. Moreover, it features access to Kline’s proprietary FutureView Forecasting model that provides Kline’s assumptions about the probability of switch and sales forecasts by company and therapeutic class. To request a sample of this report, please contact our team.