Bentley gets Spanish OK for generic lansoprazole

Bentley Pharmaceuticals of the USA says that three of its subsidiaries have been granted approval by the Spanish Ministry of Health to market generic equivalents of the antiulcerant lansoprazole in Spain.

Laboratorios Belmac, Laboratorios Davur and Laboratorios Rimafar have each received approval to market 15mg and 30mg delayed-release dosage forms of lansoprazole in Spain. The company has made the decision to announce these approvals prior to receiving product pricing because the Spanish authoritiy has made this information publicly available on its web site.

Lansoprazole is marketed in the USA by TAP Pharmaceutical, a joint venture between Abbott Laboratories and Japan's Takeda, under the trade name Prevacid. According to IMS data, the market size of this class of gastrointestinal products in Spain is approximately $415 million and growing at an annual rate of 7%. In the Spanish market, lansoprazole accounts for approximately $87 million sales and has grown 20% over the past 12 months.