Mylan N.V. has announced the U.S. launch of Lansoprazole Delayed-Release (DR) Orally Disintegrating Tablets (ODT), 15 mg and 30 mg, a generic version of Takeda’s Prevacid SoluTab DR ODT.
Mylan Pharmaceuticals received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which has the same indications as the reference listed drug, including treatment of active ulcers of the stomach and small intestine, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. T
he introduction of Lansoprazole DR ODT bolsters Mylan’s gastroenterology portfolio, which is one of the company’s major therapeutic areas, and further drives access for patients.
U.S. sales for Lansoprazole DR ODT, 15 mg and 30 mg, were approximately $168 million for the 12 months ending September 30, 2018, according to IQVIA.
Currently, Mylan has 168 ANDAs pending FDA approval representing approximately $85.9 billion in annual brand sales, according to IQVIA. Forty-four of the pending ANDAs are potential first-to-file opportunities, representing $50.3 billion in annual brand sales, for the 12 months ending June 30, 2018, according to IQVIA.
(Source: Mylan N.V.)