U.S. District Judge Dennis M. Cavanaugh issued the order Thursday, giving Lilly time to weigh its options following his Aug. 12 ruling that invalidated a patent on the medicine. The order ends 14 days after the judge signs a final judgment in that case, unless the U.S. Court of Appeals for the Federal Circuit in Washington, D.C., decides it should last through the appeal.
The invalidation of Lilly’s Strattera patent opened the door for generic copies by as many as 10 companies, including Mylan Inc., Teva Pharmaceutical Industries Ltd. and Novartis AG’s Sandoz unit. Strattera, known by its active ingredient atomoxetine, generated U.S. sales of $445.6 million last year as a treatment for attention deficit hyperactivity disorder, Lilly said in a fourth-quarter earnings statement. The Indianapolis-based company reported $21.8 billion in total annual revenue.
Lilly’s patent on Strattera would have prevented sales of copies until May 2017. The company said after the Aug. 12 ruling that it expects “near-term entry” of generic versions and reduced its sales-growth forecast for the year to the low- to mid-single digits, from the mid-single digits.
The company’s top-selling drugs Zyprexa and Cymbalta, which account for more than a third of its revenue, face generic competition by 2013. Zyprexa is used to treat schizophrenia and Cymbalta is an antidepressant.
Lilly shares dropped 44 cents, or 1.3 percent, to $34.35 each in midday trading. The shares fell 2.6 percent this year before Thursday.
A U.S. appeals court on July 28 upheld a ruling that a patent on Lilly’s cancer medicine Gemzar was invalid. The decision may allow generic competition as early as November, two years earlier than Lilly had projected. Gemzar had $747.4 million in U.S. sales last year.
Mylan, based in Canonsburg, Pa., is the largest generic-drug maker based in the U.S. Petah Tikva, Israel-based Teva Pharmaceutical is the world’s biggest, followed by Basel, Switzerland-based Novartis’s Sandoz unit.
The other generic-drug makers who had challenged the Strattera patent were Synthon BV; Iceland’s Actavis Group hf; Canada’s Apotex Inc.; and India’s Aurobindo Pharma Ltd., Glenmark Pharmaceuticals Ltd., Sun Pharmaceutical Industries Ltd. and Cadila Healthcare Ltd.’s Zydus.