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, a specialty pharmaceutical company, has confirmed that it has initiated a challenge of the patents listed by Genzyme, a biotechnology company, in connection with its Renvela 800mg tablets.
Subscribe to our email newsletter
Impax has filed its abbreviated new drug application (ANDA) containing a paragraph IV certification for a generic version of Renvela with the 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 owner of its paragraph IV certification.
On April 3, 2009, Genzyme filed suit for patent infringement against Impax in the US District Court of Maryland. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s generic division, will commercialize the products. Renvela is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.