(Reuters) - Amgen Inc sued generic drugmaker Aurobindo Pharma Ltd in Delaware federal court, alleging in a complaint entered Friday that Aurobindo's planned generic of its drug Parsabiv to treat a parathyroid condition in dialysis patients will infringe its patents.
India-based Aurobindo filed an Abbreviated New Drug Application in March for U.S. Food and Drug Administration approval of the generic. An ANDA asserts that the relevant drug patent is invalid or would not be infringed by the generic, and opens the filer to patent infringement claims from the patent owner.
Thousand Oaks, California-based Amgen declined to comment. Aurobindo didn't immediately respond to a request for comment.
Parsabiv is an intravenous injection used to treat hyperparathyroidism -- where parathyroid glands become overactive -- in adult hemodialysis patients with chronic kidney disease. Its active ingredient is etelcalcetide, and was approved by the FDA in 2017.
According a February Amgen report, the company sold over $700 million 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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