FDAnews Drug Daily Bulletin

Dr. Reddy’s Laboratories has entered into a settlement agreement with Novartis that dismisses lawsuits filed in the U.S. relating to Dr. Reddy’s abbreviated new drug application (ANDA) for generic Exelon capsules.

Also this past week, Ranbaxy Laboratories announced it had settled matters relating to possible patent litigation with GlaxoSmithKline (GSK) over Imitrex (sumatriptan succinate) tablets.

Under the terms of the Dr. Reddy’s-Novartis agreement, Dr. Reddy’s will not launch generic Exelon (rivastigmine tartrate) capsules until sometime before the expiration of the FDA Orange Book patents on the drug in 2012 and 2014, but the exact date of launch and other terms of the agreement were not revealed.

The drug is indicated as a treatment for mild to moderate forms of Alzheimer’s disease and dementia associated with Parkinson’s disease.

The terms of the settlement between Ranbaxy and GSK will allow Ranbaxy to distribute a generic version of the migraine drug Imitrex 25-, 50- and 100-mg tablets in the U.S. Additional terms of the settlement agreement were not disclosed.