Recently, in Europe and Japan there have been increased Rx-to-OTC switch approvals and an environment fostering switch. The OTC men’s health category is growing in Europe, with the switch approval of Recordati’s Fortacin (lidocaine 7.5mg/prilocaine 2.5 mg) spray for premature ejaculation, via the centralized switch procedure through the European Medicines Agency. This drug marks the fifth medicine approved for switch through this centralized regulatory body, and it is expected to be launched throughout the EU on a nonprescription basis by early 2021.
Recently released data from our Nonprescription Drugs USA study shows that the U.S. nonprescription drugs industry posted moderate growth in 2014, recording revenue growth for the sixth consecutive year. Estimated at $24+ billion at the manufacturers’ level, the market climbs by 1.4% from 2013 to 2014. Out of the seven product classes we track, five posted growth, with upper respiratory, digestive products, and feminine products moving at a faster pace.
Among the key factors supporting the market’s growth are the sales and shares increases from select switch brands, such as Pfizer’s Nexium 24HR, which drove solid growth in the digestive products category, as well as the launch of Sanofi’s Nasacort 24HR, which generated healthy gains in the allergy category.Continue reading
In 2014, two intranasal steroids for the treatment of allergic rhinitis received FDA approval for Rx-to-OTC switch—Sanofi’s Nasacort Allergy 24 Hour and GlaxoSmithKline’s Flonase Allergy Relief. Nasacort entered the OTC market in February 2014 and according to recently released data from Kline’s Nonprescription Drugs USA study, from February through December 2014, the product generated about $100 million in sales at the manufacturers’ level. Kline pegs the overall allergy market up 10.0% to over $1.8 billion in sales at the manufacturers’ level.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