Mylan's Lansoprazole Delayed-Release Orally Disintegrating Tablets are approved to treat certain types of gastrointestinal ulcers
HERTFORDSHIRE, EnglandandPITTSBURGH/PRNewswire/ -- Global pharmaceutical companyMylan N.V.(NASDAQ:MYL) today 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. The 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 millionfor the 12 months endingSeptember 30, 2018, according to IQVIA.
Currently, Mylan has 168 ANDAs pending FDA approval representing approximately$85.9 billionin annual brand sales, according to IQVIA. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing$50.3 billionin annual brand sales, for the 12 months endingJune 30, 2018, according to IQVIA.
Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time.