Mylan joins patent challenge on Pfizer antidepressant drug
PITTSBURGH — Mylan is challenging the patent protection on a Pfizer drug for treating depression, following an announcement of a similar challenge by Watson made earlier this week.
Mylan said it had filed for Food and Drug Administration approval of a generic version of Pristiq (desvenlafaxine succinate) extended-release tablets in the 50-mg and 100-mg strengths.
The application contained a paragraph IV certification, a legal assertion that the drug's patent protection is invalid, unenforceable or won't be infringed, prompting a patent-infringement lawsuit by Pfizer and others in the U.S. District Court for the District of Delaware.
Watson announced Tuesday that it also had challenged the drug's patent protection and was sued, and Mylan said it expected to share a 180-day period of market exclusivity in which to compete directly with Pfizer's product following FDA approval.
Pristiq had sales of $559.4 million during the 12-month period ended in March, according to IMS Health.