OTC Prevacid (lansoprazole) will be available by 2009, according to an agreement between TAP Pharmaceutical Products Inc and Novartis. The proton pump inhibitor (PPI) is indicated for the short-term treatment of heartburn and other symptoms of gastroesophageal reflux disease.
Under the terms of the agreement, TAP has agreed to license its Prevacid trademark and certain other intellectual property to Novartis for development and future commercialization in the OTC market. TAP will continue to market and sell prescription Prevacid until at least 2009, when the compound patent expires, while Novartis takes on full responsibility for what is anticipated to be a multiyear OTC development. The development includes the design and conduct of all clinical studies, product development activities, regulatory submissions to the FDA, commercialization, manufacturing, product launch, and distribution.
Industry experts predict that the Prevacid agreement will bring about one of the most significant switches of a prescription drug to OTC status in North America in the next decade. The OTC market in the United States was valued at $17.4 billion in annual sales in 2004, with the gastrointestinal category ranking third at $2.3 billion in sales, according to Novartis. Currently, Prilosec (Procter & Gamble) is the only OTC PPI available. That drug received FDA approval for the prescription-to-OTC switch in June 2003 and was launched over the counter in September 2003.