Ranbaxy to sell ranitidine 75mg tablets in the US

Ranbaxy Pharmaceuticals Inc., the wholly owned subsidiary of Ranbaxy India Ltd., has been given tentative approval by the US Food and Drug Administration to manufacture and market anti-ulcerant ranitidine 75 mg tablets in the US. Ranbaxy is positioning its ranitidine 75 mg tablet as an over-the-counter formulation.

The ranitidine tablets are expected to be marketed in the US from January 20, soon after the 180-day exclusivity period granted to by the US FDA expires in the third week of January. Novopharm, a Canadian company, was the first to file an for ranitidine 75 mg form and hence granted 180-day exclusivity.

Ranbaxy already manufactures 150 mg and 300 mg ranitidine over-the-counter formulations in the US and the inclusion of 75 mg dosage will extend the company's ranitidine range. Ranitidine is the original research molecule of Glaxo.

Ranbaxy had originally intended to launch its ranitidine 75 mg form in the US markets in June 1999, but its attempt was thwarted by Glaxo. On December 18, 1998, a day before the ranitidine product patent expired, Glaxo appealed to the US drug authorities for patent extension on ranitidine 75 mg dosage form on grounds of paediatric exclusivity. Glaxo cited latest research that showed therapeutic efficacy and safety of ranitidine 75 mg in children suffering from gastric disorders. As a result, Glaxo exclusivity period was extended for another six months from the date of filing the application. Hence, Ranbaxy had to wait till January 2000 as the 180-day exclusivity period granted to Novopharm began after Glaxo's extended deadline.

Ranbaxy markets ranitidine dosage forms in the US through a joint venture with US-based . According to a company release, PL Developments of the US will represent Ranbaxy and Schein Pharma in the OTC and private label market place. PL developments will provide packaging, logistical, and sales and marketing expertise for the commercialisation of the product.

Ranbaxy produces ranitidine at its Paonta Sahib facility and at Schein's unit in the US. Ranbaxy is targeting a $150 million from the US business by 2002.