PRINCETON, N.J., Dec. 22 /PRNewswire/ -- Ranbaxy Laboratories Limited (Ranbaxy) announced today that it has entered into an agreement with Cephalon, Inc. to settle their pending patent infringement dispute in the United States related to PROVIGIL(R) (modafinil) Tablets [C-IV].
In connection with the settlement, Cephalon will grant Ranbaxy a non-exclusive royalty-bearing right to market and sell a generic version of PROVIGIL in the United States. Ranbaxy’s license will become effective in October 2011 absence of a pediatric extension for PROVIGIL, which would delay the entry date by six months (to April, 2012). An earlier entry by Ranbaxy may occur based upon the entry of another generic version of PROVIGIL.
The companies also agreed to a series of business arrangements related to modafinil. Specifically, Ranbaxy has agreed to grant to Cephalon a non-exclusive license, effective immediately, to certain of its worldwide intellectual property rights related to modafinil in exchange for milestone payments. Cephalon also has agreed to enter into certain arrangements with Ranbaxy related to Ranbaxy’s supply of the active pharmaceutical ingredient modafinil.
The terms of the agreement are confidential, and are subject to review by the U.S. Federal Trade Commission. Financial terms were not disclosed.
The parties promptly will file a dismissal with prejudice with the United States District Court for the District of New Jersey that will conclude all pending litigation between the parties regarding PROVIGIL. These lawsuits claim infringement of Cephalon’s U.S. Patent No. RE37, 516 (“the ‘516 Patent”) which covers pharmaceutical compositions and methods of treatment with the form of modafinil contained in PROVIGIL. The ‘516 Patent expires in October 6, 2014 and may be extended by six months (to April 6, 2015) upon submission of pediatric study data that is acceptable to the U.S. Food and Drug Administration.
Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies.
Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary “platform technologies”, resulting in a number of products under development. The Company is serving its customers in over 100 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 46 countries and manufacturing operations in 7 countries.
*PROVIGIL(R) is a registered trademark of Cephalon, Inc.
Ranbaxy Laboratories Limited
CONTACT: Charles M. Caprariello, Vice President, Corporate Communications,Ranbaxy Inc., +1-609-720-5615; or Edwige Buteau, +1-212-994- 7517, or AnujBaveja, +1-212-994-7552, both of RF Binder Partners Inc. for Ranbaxy Inc.
Web site: http://www.ranbaxy.com/
