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Will the FDA’s OTC Monograph Reform Foster Innovation Including Increased Rx-to-OTC Switch Activity?

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

New FDA Approvals

Switch Activity Heating Up with New OTC Approvals

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 pill” may be easier to obtain in the United States in the near future

“The pill” may be easier to obtain in the United States in the near future

Oral contraceptives (OCs), known commonly as “the pill,” are prescription medications that prevent pregnancy. The most common brands of OCs contain hormone combinations of estrogen, progestin, and/or progesterone. These products have been used for years and were first launched on the U.S. prescription market in the 1960s. While OCs resulted in a new era of pregnancy protection for women, they were not without potential side effects to be considered, including risk of blood clots, heart attack, stroke, high blood pressure, and breast cancer (particularly for women who smoke). To date, OCs have proven to be one of the most popular forms of birth control, due to ease of use, efficacy, and their good safety profile for most women. Continue reading

OTC Market Forces Impact Industry Growth

Internal and External OTC Market Forces Impact Industry Growth

The U.S. OTC market overall experienced 2.0% growth in 2017 with upper respiratory and topical products classes posting higher than average gains, according to Kline’s Nonprescription Drugs USA 2017 annual market study. “A strong cold and flu season in both Q1 and Q4 of 2017 drove the OTC cold and sinus market up 4.5% from 2016 levels,” says Laura Mahecha, Industry Manager for Kline’s Healthcare Practice. The topical products class posted 3.6% growth in 2017, driven by strong gains for OTC topical analgesics.Continue reading

Rx-to-OTC Switch Forecasts

Safety and caution characterize the next frontier of Rx-to-OTC switches

Companies are being more selective in the Rx-to-OTC switches they pursue, according to new research just published by Kline & Company in the 13th study in its venerable syndicated series, Rx-to-OTC Switch Forecasts USA: Next Frontier.

Safety is paramount, and the sophistication of clinical studies required to gain approval has increased the cost burden and risk to switch sponsors. Most future switches will depend on a combination of market-driven forces and safety, as determined by regulators. Continue reading

Sales Resurgence of U.S. OTCs in 2013 Helps the Market Overcome Flat Sales Performance of the Past

Sales Resurgence of U.S. OTCs in 2013 Helps the Market Overcome Flat Sales Performance of the Past

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

Rx-to-OTC Switch

Broader Opportunities in Rx-to-OTC Switch

There have been signs recently indicating that the environment is becoming ripe for more Rx-to-OTC switches. Since we last reported on this topic in August 2013, we saw the approval of two additional first-in-class switches in categories that would have been thought of as challenging five years ago. One is the first incontinence medication available for sale without a prescription, Merck’s Oxytrol for Women, and the other is the first nasal allergy steroid, Sanofi’s Nasacort Allergy 24HR.Continue reading

OTC Market Intelligence

50 Years Old and Still Bounding Over the Counter: Kline’s Healthcare Practice Continues to Deliver Unmatched OTC Market Intelligence

With over half a century of market insights on the U.S. consumer healthcare market, Kline & Company expects that new paradigm shifts in regulations, retail, and technology will create new opportunities for medications to move along the Rx-to-OTC continuum and more growth prospects for the U.S. OTC market. Additionally, with the OTC medication market in the United States nearing $23 billion in 2012 alone and with the FDA – through its recent NSURE (Nonprescription Safe Use Regulatory Expansion) initiative – showing encouraging indications that it is becoming more receptive to allowing more Rx-to-OTC switches, the U.S. OTC market is fast returning to pre-recession health.Continue reading