In a first out-of-court settlement of a patent infringement dispute involving an Indian pharmaceutical company, Ranbaxy Laboratories has signed an agreement in the US with Cephalon Inc. |
Cephalon will grant Ranbaxy a non-exclusive royalty-bearing right to sell a generic version of psychostimulant Provigil (Modafinil) tablets in the US. |
This comes on the heels of a US district court striking down Ranbaxy's challenge to Pfizer's patent on Lipitor, an anti-cholesterol drug that generates $12 billion a year. |
Ranbaxy's licence will become effective in October 2011 in the absence of a pediatric extension for Provigil, which will delay the entry date by six months. |
"An earlier entry by Ranbaxy may occur on the basis of the entry of another generic version of Provigil," said a statement issued by Ranbaxy today. |
The two companies have agreed to a series of business arrangements related to Modafinil. |
Ranbaxy has agreed to grant Cephalon an immediate non-exclusive licence to some of its worldwide intellectual property rights related to Modafinil in exchange for milestone payments. |
Cephalon has agreed to have an arrangement with Ranbaxy on the supply of the active pharmaceutical ingredient, Modafinil. |
The two parties will file for dismissal of the case in the district court of New Jersey. The out-of-court settlement is subject to the approval of the US Federal Trade Commission. |