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.
After years of the OTC industry and the Consumer Healthcare Products Association working with the FDA to pass long-overdue OTC monograph reform and regulatory modernization, long-sought-after reform is now a reality thanks to the CARES (Coronavirus Aid, Relief, and Economic Security) Act. The act, which was passed by the U.S. Congress and signed into law by President Donald Trump on March 27, 2020, provides more than $110 million over five years for the FDA to significantly increase capacity and expertise in the Office of Nonprescription Drug Products. Continue reading
The U.S. FDA announced approval of three Rx-to-OTC switches on February 14, 2020. One is GlaxoSmithKline’s OTC version of its topical nonsteroidal anti-inflammatory (NSAID) pain reliever, Voltaren Gel (diclofenac sodium topical gel, 1%). This OTC medication will be indicated for temporary relief of joint pain and stiffness due to the most common type of arthritis, osteoarthritis, which increases with age, affects millions of people in the U.S., and can generally be self-diagnosed. Arthritis is the swelling and tenderness of one or more of the joints. Symptoms of arthritis include pain, swelling, stiffness, and difficulty moving a joint. This medication has been sold without a prescription safely for years in Europe and marks the first topical analgesic with anti-inflammatory properties available without a prescription in the United States. It also offers another non-opiate option for those suffering from chronic arthritis pain. Continue reading
The U.S. OTC market posted 2.2% growth overall from 2015 to 2016, according to Kline’s venerable Nonprescription Drugs USA annual market assessment study. However, topical analgesics, nasal allergy medications, herbal products, and contraceptive products posted much higher rates of dollar sales growth. The calendar year of 2016 was marked as being a weak cold and flu season, which put a damper on sales of many OTC upper respiratory brands and market segments. However, in contrast, nasal allergy sprays grew by double digits, driven by growth of newer Rx-to-OTC switch brands, Flonase Allergy Relief (GlaxoSmithKline), and the addition of Rhinocort Allergy Spray by Johnson & Johnson to the market. This rapid uptake of nasal allergy sprays resulted in a small decline in sales of oral allergy medications. Continue reading
Driven by the market return of popular OTC brands from Johnson & Johnson and GlaxoSmithKline, as well as the success of several Rx-to-OTC switch brands, the U.S. OTC market increases by a solid 4% in 2015, reveals our recently published Nonprescription Drugs USA report.
In October 2015, Johnson & Johnson announced that the FDA approved the reopening of the Fort Washington, PA, plant that had been shuttered since May 2010. Johnson & Johnson’s key brands, including Tylenol Arthritis Pain and Tylenol 8 Hour, are re-launched in 2015, supporting overall sales growth of the OTC drugs market. Steady distribution of Zyrtec and other key brands from the market leader, Johnson & Johnson, help propel sales in the OTC market.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
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
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.Continue reading
According to Kline’s Nonprescription Drugs USA study, the U.S. OTC market grew over 3.0% during 2013 to reach $23.5 billion at the manufacturers’ level. Driven by strong sales gains in analgesics, upper respiratory, nutritional, and topical products, the market appears to be showing signs of recovery. This is partly due to the long-awaited rejuvenation of several brands that have posted steep declines in the recent past as a result of supply disruptions and recalls. Brands such as Novartis’ Excedrin and Johnson & Johnson’s Tylenol and Motrin IB have experienced strong gains in 2013 thereby helping the analgesics category to post very strong gains this past year while Pfizer’s Advil, Bayer’s Aleve, and private-label analgesics also posted gains in 2013. Continue reading