Abon seeks approval for generic leukemia drug
NORTHVALE, N.J. — Abon Pharmaceuticals is challenging the patent protection on an injected drug used to treat leukemia in children and adolescents, the company said Tuesday.
Abon said it filed with the Food and Drug Administration for regulatory approval of clofarabine in the 1 mg-per-mL strength. The drug is a generic version of Genzyme's Clolar, used to treat relapsed or refractory acute lymphoblastic leukemia in patients ages one to 21 years, who already have undergone at least two regimens.
Genzyme, now part of French drug maker Sanofi, filed suit against Abon on Friday in the U.S. District Court for the District of New Jersey to prevent the commercialization of the generic drug before the expiration of U.S Patent No. 5,661,136, which takes place in 2018. As the first company to file an approval application with the FDA for a generic version of Clolar, Abon would be entitled to 180 days in which to compete exclusively against the branded version of the drug.
Clolar had sales of $77.5 million during the 12-month period ended in June, according to IMS Health.