Mylan's Unit Introduces Generic Version Of Aciphex Tablets - Quick Facts

(RTTNews) - Mylan Inc.'s (MYL) U.S.-based subsidiary, Mylan Pharmaceuticals Inc., has launched Rabeprazole Sodium Delayed-release Tablets, 20 mg, which are the generic version of Eisai Corporation's Aciphex Tablets, indicated for short-term treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease, and for short-term treatment in the healing and symptomatic relief of duodenal ulcers. The company received final approval from the U.S. Food and Drug Administration or FDA for its Abbreviated New Drug Application or ANDA for this product.

According to IMS Health, Aciphex Tablets, 20 mg, generated sales of about $830.1 million in the U.S. for the year ending September 30, 2013.

Presently, Mylan has 179 ANDAs pending FDA approval representing $90.5 billion in annual sales, according to IMS Health. Of these, forty pending ANDAs are potential first-to-file opportunities, representing $24.1 billion in annual brand sales, for the year ending June 30, 2013, IMS Health stated.