Amgen sues Micro Labs over Sensipar generic

Amgen has filed a complaint against Indian drug company Micro Labs for allegedly infringing a patent centring on Sensipar (cinacalcet hydrochloride).

Filed in the US District Court for the District of Delaware on September 22, Amgen’s suit alleged Micro Labs has infringed US patent number 9,375,405.

Sensipar is a drug used to treat secondary hyperparathyroidism in patients with chronic kidney disease.

The dispute arose after Micro Labs filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking to sell and manufacture a generic version of Sensipar before the the patent expires.

Micro Labs notified Amgen of the ANDA on August 8.

In its notice, Micro Labs alleged that the patent was invalid and would not be infringed by the proposed generic.

“Amgen will be substantially and irreparably harmed by the infringing activities described above unless those activities are enjoined by this court. Amgen has no adequate remedy at law,” said the suit.

Amgen is seeking injunctive relief and costs, expenses and disbursements. Amgen has also asked the court to order that the effective date of any FDA approval of the generic product be later than the patent’s expiry date.