SOURCE: Kalorama Information

Kalorama Information

September 06, 2012 10:13 ET

Helpful FDA Approach Boosts OTC Drug Market

NEW YORK, NY--(Marketwire - Sep 6, 2012) - The FDA is continuing to review prescription drugs for potential switches, which is assisting the OTC drug market, according to Kalorama Information. The healthcare market research publisher says that several products are being discussed including those for pain, overactive bladder, an emergency kit for bacterial infections, cholesterol, high blood pressure and migraines, as noted in its report "Over the Counter (OTC) Drug Markets."

Over-the-counter, non-legend, and non-prescription are all adjectives describing drugs that an individual may purchase without a prescription. Many pharmaceutical companies seeking more revenue and international exposure have found an opportunity in the development of OTC drugs. OTC drugs are sold to consumers by convenience and grocery stores. However, new technology has allowed a new range of outlets including online sales and catalogs. The FDA has outlined several methods for improving the flow of switches from prescriptions into the OTC market, including new ways of dosing existing Rx products, new indications for Rx products that may be suitable for OTC, and Rx-to-OTC switches for products reaching patent expiration which are OTC compatible. 

"We are beginning to see the early preparations for a boost to the OTC market with revived FDA attention to Rx-to-OTC switches," said Melissa Elder, analyst for Kalorama Information and the author of the report. "Keep an eye on companies like Merck -- known for attempting to provide first-in-category switches." 

For example, a meeting in November 2012 with the FDA will evaluate the oxybutynin transdermal system for OTC use as a treatment for overactive bladder in women. 

Kalorama Information estimates the market for such OTC approaches to be $78 billion in 2011. Growth has been sluggish in the past few years, but consumer demand and favorable regulation will drive growth in the market as controlling healthcare costs has become a primary concern in recent years. 

Kalorama Information's report, "Over the Counter (OTC) Drug Markets," includes the incidence of conditions which are often treated with OTC medicines, health statistics related to the industry, birth rates, world population, populations by region and issues affecting the market as a whole. Information is presented as a worldwide overview, with special emphasis on the U.S., Japan, Germany, and other key markets. The market segments provide an overview of demographics, overview of products available in each region, market estimates and forecasts. Additionally, a competitive analysis of leading providers and profiles of providers is covered.

About Kalorama Information
Kalorama Information, a division of, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog.

Contact Information