Fresenius Kabi, one of four business segments of the worldwide dialysis giant Fresenius Medical Care, was slapped with a lawsuit this week alleging that the company was violating patents for the cancer dug Isodax.
Drug makers Celgene Corp. and Astellas Pharma claim that Fresenius Kabi filed an abbreviated new drug application with the Food and Drug Administration (FDA) to manufacture and sell a generic version of romidepsin for injection. The companies allege that doing so violates two active patents.
Isodax is used to treat cutaneous T-cell lymphoma, a type of non-Hodgkin’s lymphoma, in patients who have received at least one prior systemic therapy. The drug is from a new class of cancer medications known as histone deacetylace inhibitors. The drug has an extended exclusivity period on two patents-in-suit under the Orphan Drug Act, a law designed to encourage the development and marketing of drugs for rare diseases and conditions.
The lawsuit was filed two months after Fresenius Kabi sent letters to Celgene and Astellas maintaining that the generic romidepsin for injection will neither violate or infringe on the brand name drug.
Fresenius Kabi’s parent company, Fresenius Medical Care, is currently facing its own lawsuits alleging the company withheld from doctors and patients sudden cardiac arrest risks associated with its dialysis concentrates GranuFlo and NaturaLyte. The company informed only doctors in its clinics of its confusing labeling, which could lead to an overdose of its products, resulting in cardiovascular events including sudden cardiac arrest. After the FDA was made privy to Fresenius’ failure to warn patients or doctors in other dialysis clinics who used its products, the dialysis giant issued a recall and notified others of the risks.