The U.S. FDA approved five new branded Rx-to-OTC switches in 2020, including eye drops, an external analgesic, and a lice treatment. In addition, private-label companies such as Perrigo and Mylan gained approval for store brand versions of Voltaren Arthritis Pain Gel, Prevacid 24HR proton pump inhibitor, and Nicorette smoking cessation gum this year. These approvals come after a lull in switch activity during the past two years. Continue reading
When considering a potential switch, the FDA is tasked with weighing the benefits of enhanced access against the incremental risks greater access will pose. In doing so, the FDA will generally consider the efficacy and safety profile of a drug based upon the studies conducted to gain Rx approval, as well as the clinical knowledge gained from first-hand experience of the product usage on the Rx marketplace. In addition, the FDA requires additional studies with consumers demonstrating that they can use the product safely in an OTC setting without third-party intervention.Continue reading
In contrast to the U.S. FDA, regulatory agencies outside the United States have been much more aggressive in approving switches for conditions outside the typical OTC paradigm. The United Kingdom in particular takes pride in being at the forefront of switching. U.K. Pharmacy Minister Earl Howe has continually stressed that increasing patient choice by making more medicines available without a prescription is a priority for the British government. When speaking at the Proprietary Association of Great Britain conference in London on July 5, 2012, he stated, “The United Kingdom leads the world in the range of products available without a prescription—but more can always be done.” Continue reading
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.Continue reading
Analyzing and forecasting Rx-to-OTC switch sales for over 50 years at Kline, we have recently reviewed how accurate our forecasts have been over time. Over the past 8-10 years, Kline’s syndicated studies on Rx-to-OTC switch have included comprehensive written analyses as well as an Excel-based forecasting model that provides both a percentage probability of switch as well as forecasted OTC brand sales post-switch. Among brands that have been analyzed in Kline’s series of reports on Rx-to-OTC switch are Motrin, Nuprin, Monistat, Aleve, Claritin, Allegra, Zyrtec, Zantac, Pepcid, Nicorette, Nicotrol,
Plan B, Prilosec OTC, Prevacid, Zegerid, Miralax, Alli, Oxytrol for Women, and many others.Continue reading