Amgen Inc sued generic drugmaker Aurobindo Pharma Ltd in Delaware federal court, alleging in a grievance entered Friday that Aurobindo’s prepared generic of its drug Parsabiv to address a parathyroid situation in dialysis people will infringe its patents.
India-centered Aurobindo submitted an Abbreviated New Drug Software in March for U.S. Food stuff and Drug Administration acceptance of the generic. An ANDA asserts that the appropriate drug patent is invalid or would not be infringed by the generic, and opens the filer to patent infringement claims from the patent proprietor.
Thousand Oaks, California-dependent Amgen declined to comment. Aurobindo didn’t right away reply to a ask for for remark.
Parsabiv is an intravenous injection utilised to treat hyperparathyroidism — in which parathyroid glands come to be overactive — in grownup hemodialysis people with continual kidney disorder. Its energetic ingredient is etelcalcetide, and was authorized by the Fda in 2017.
According a February Amgen report, the enterprise sold about $700 million truly worth of Parsabiv in fiscal year 2020.
The case is Amgen Inc. v. Aurobindo Pharma Ltd., U.S. District Court for the District of Delaware, No. 1:21-cv-00662.
For Amgen: Adam Perlman of Latham & Watkins, Jack Blumenfeld of Morris Nichols Arsht & Tunnell
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