Impax faces generic Oxycontin patent challenge
HAYWARD, Calif. — Another generic drug maker is seeking to market its version of a popular opioid painkiller.
Impax said it had filed applications with the Food and Drug Administration seeking approval for a generic version of Purdue Pharma’s Oxycontin (oxycodone) controlled-release tablets in the 10-, 15-, 20-, 30-, 40-, 60- and 80-mg strengths.
Purdue filed suit against Impax on April 8 in the U.S. District Courts for the Southern District of New York, seeking to prevent Impax from marketing its version before the expiration of Purdue’s patents.
According to Wolters Kluwer Health, aggregate U.S. sales of Oxycontin since launch were approximately $2.8 billion for the 12 months ended in January.
Pfizer, Medivation ‘disappointed’ in phase-3 trial results for Dimebon
NEW YORK — A drug originally developed by scientists in the Soviet Union to treat allergies and currently under investigation by Pfizer and Medivation did not yield significant results in a late-stage clinical trial of patients with Huntington disease, a disorder that leads to cognitive decline, the companies said Monday.
In the phase-3 “HORIZON” trial, Dimebon (latrepirdine) did not produce a statistically significant improvement in patients’ conditions, leading the companies to cancel the study, which had enrolled more than 400 patients. Another study, “CONCERT,” in patients with Alzheimer’s disease is ongoing.
“We are disappointed with the results of the HORIZON trial given the high unmet need in this patient population,” Medivation president and CEO David Hung said. “At this point, we will discontinue development of Dimebon in Huntington disease, including the ongoing open-label extension study.”
Sandoz gets FDA nod for Altavera
PRINCETON, N.J. — The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.
Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Altavera (levonorgestrel and ethinyl estradiol) tablets, a generic version of Duramed’s Nordette.
Branded and generic versions of Nordette had sales of about $57.4 million during the 12-month period ended in February, according to IMS Health.