Toronto, ON – Apotex Inc. announced today that it has launched the first generic version of Merck's Nasonex® nasal spray (mometasone furoate monohydrate) in the United States.
Apotex's mometasone furoate nasal spray is a once-daily anti-allergen indicated for treatment of nasal congestion. According to IMS Health, Nasonex® had approximately $955.5 million in sales in the 12 months ending January 2016.
"We are very pleased to make a more affordable version of this important allergy medicine available to the US public. Apotex is dedicated to bringing high quality versions of complex generic products to market, and we are delighted that these efforts will generate substantial savings for the US health care system," said Apotex Chief Executive Officer and President, Dr. Jeremy B. Desai. "The amount of work required by all stakeholders to enable the launch of a first generic of this complexity cannot be overstated, and we appreciate the role of everyone involved, including the FDA who provided steady guidance throughout the development process," Desai added.
FDA's approval of the company's generic version of Nasonex® follows Apotex's successful Hatch-Waxman challenge of US Patent No. 6,127,353 (the '353 patent), which Merck claimed covered the active ingredient. In June 2012, the US District Court for the District of New Jersey found that Apotex's product did not infringe the '353 patent. The decision was upheld in June 2013 by the Federal Circuit.
Apotex is the 7th largest generic pharmaceutical company globally (according to IMS Health) with over 8,000 employees and estimated sales of approximately $2 billion. The company's US headquarters is based in Weston, Florida. With its worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. It produces 300 medicines in 4,000 dosages and formats that are exported to 115 countries. It has 500 products under development and will spend $2 billion over the next 10 years on research and development.
Global Director, Corporate Communications