Barr confirms Sensipar patent challenge
US generics group Barr Pharmaceuticals, which is the subject of an agreed $7.46 billion takeover offer from Israel's Teva Pharmaceutical Industries (Marketletter July 28), has confirmed that its subsidiary, Barr Laboratories, has initiated a challenge of the patents listed by Amgen in connection with its Sensipar (cincalcet HCl) 30mg, 60mg and 90mg tablets .
Barr's Abbreviated New Drug Application containing a Paragraph IV certification for a generic Sensipar product was received as acceptable for filing by the Food and Drug Administration on March 10, the first date the FDA could accept an ANDA with this certification for the product. Following receipt of the notice from the FDA that its ANDA had been accepted for filing, Barr notified the New Drug Application and patent holder.
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