By PETER LOFTUS
U.S. District Judge Gregory M. Sleet ordered Thursday that generic manufacturers who were seeking to sell copies of Lyrica must wait until the expiration of patents covering the drug, whose active ingredient is called pregabalin.
Pfizer said in a written statement: “With this decision, Pfizer will exclusively provide pregabalin as Lyrica to patients through December 30, 2018, in the U.S., pending generic company appeal and further litigation.”
The generic companies had challenged the validity of patents covering Lyrica. As part of that process, beginning in 2009, several manufacturers, including Teva Pharmaceutical Industries Ltd. TEVA -0.64% and Mylan Inc., MYL +0.18% notified Pfizer they had applied for U.S. Food and Drug Administration approval to market generic versions of Lyrica before it lost patent protection.
Pfizer filed patent-infringement lawsuits against the companies in federal court in Delaware beginning in 2009, seeking to block the launch of any competing generic versions of Lyrica before the patent expirations. A trial was held in October 2011 before Judge Sleet.
Most of the generic makers had agreed not to launch generic versions of Lyrica before Friday or a court decision if that came earlier, according to a court document.
Lyrica is approved to treat several conditions including diabetic nerve pain, pain after shingles, fibromyalgia and partial-onset seizures in adults with epilepsy.
The drug generated $3.7 billion in sales for 2011.
Three Lyrica patents were challenged by the generic drug makers: one covering the active ingredient pregabalin and expiring in December 2018; a second covering a method for using pregabalin to treat seizure disorders and expiring in October 2013; and a third covering methods for using pregabalin to treat pain and expiring in December 2018.
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