Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Impax Laboratories has confirmed that it has initiated a challenge of patents listed by Daiichi Sankyo in connection with its Welchol (Colesevelam HCl) for Oral Suspension, 3.75gm/packet and 1.875gm/packet.
Subscribe to our email newsletter
Welchol is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa).
Daiichi Sankyo and Genzyme Corporation filed suit for patent infringement against Impax in the US District Court for the District of Delaware on 19 November 2010.
Impax filed its abbreviated new drug application (ANDA) containing a paragraph IV certification for a generic version of Welchol with the US Food & Drug Administration (FDA).
Following receipt of the notice from the FDA that Impax’s ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owners of its paragraph IV certification.