Impax sued for patent infringement over generic Welchol
HAYWARD, Calif. A generic drug maker confirmed a patent challenge for its version of a branded cholesterol drug that recently was submitted to the Food and Drug Administration for approval.
Impax said Daiichi Sankyo and Genzyme are seeking to block Impax’s generic version of Welchol (colesevelam HCl) for oral suspension, in 3.75 g/packet and 1.875 g/packet strengths. The two drug makers filed suit for patent infringement against Impax in the U.S. District Court for the District of Delaware after being notified that the FDA accepted Impax’s ANDA for the drug.
U.S. sales of Welchol for oral suspension were approximately $39 million for the 12-month period ended in September, according to Wolters Kluwer Health.
Dr. Reddy’s launches generic Accolate
HYDERABAD, India Indian generic drug maker Dr. Reddy’s Labs has launched a version of an asthma drug for the U.S. market, the company said.
Dr. Reddy’s announced the launch of zafirlukast tablets in the 10-mg and 20-mg strengths. The drug is a version of AstraZeneca’s Accolate, which had sales of $50 million during the 12-month period ended in August, according to IMS Health.
The launch follows a decision in the U.S. District Court of New Jersey determining that the Dr. Reddy’s launch of the drug does not infringe on AstraZeneca’s patents. The Food and Drug Administration approved the drug last Thursday.
Steven Miesowicz appointed to new role at Diplomat Specialty Pharmacy
FLINT, Mich. Diplomat Specialty Pharmacy has promoted Steven Miesowicz to VP human resources, planning and government relations, the company said Monday.
Miesowicz previously served as the company’s senior director for human resources and as a business management consultant. He had a large role in securing the Michigan Economic Growth Authority tax credit that the company received in connection with the relocation to its new Flint, Mich., headquarters.
In his new position, Miesowicz will be responsible for human resources, strategic planning, organizational development, leading acquisition teams and working with government agencies, the company said.
“Steven brings a broad range of skills and experience that complements our core abilities and positions us for the future,” Diplomat president and CEO Phil Hagerman said.