Teva Pharmaceutical Industries and Perrigo said today they will launch a generic equivalent to the Merck chemotherapy cancer drug Temodar® (temozolomide).
Temodar is indicated for adults with newly diagnosed glioblastoma multiforme who are undergoing concomitant radiotherapy followed by maintenance treatment, as well as for refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea as well as procarbazine.
Teva said it will manufacture, market, and distribute the product in the United States, where both companies will equally share in the cost and profitability of the product. Teva was first to file for approval to market a generic version of the drug, which as a result is eligible for 180 days of marketing exclusivity.
Teva had not launched its generic Temodar when it won the right to do so in 2010. That year a federal district court ruled in favor of Teva, concluding that a patent held by Merck’s Schering unit and licensed by the United Kingdom-based Cancer Research Technology was unenforceable. Teva instead agreed to withhold its product pending the outcome of a Merck appeal. In exchange, Merck said Teva could launch a generic version of Temodar in August of this year, six months before the expiration of Merck’s patent.
Merck persuaded the U.S. Court of Appeals for the Federal Circuit to overturn the trial court decision, and the U.S. Supreme Court rejected hearing a Teva appeal.
After winning FDA approval in 1999 for use in the United States, Temodar generated $917 million in global sales last year for Merck, down 2% from 2011, according to the company—including about $423 million in U.S. sales, according to IMS Health data cited by Teva and Perrigo. During the first half of this year, Temodar racked up $434 million, down 6% from the first half of 2012.
Temodar is available in capsule and injectable forms.