Sandoz, Inc. to Drop Challenge to PROVIGIL(R) Patent
Cephalon, Inc. reported that Sandoz, Inc. has notified Cephalon that it will no longer challenge Cephalon's U.S. particle-size modafinil patent. Instead, Sandoz said it intends to convert its abbreviated new drug application (ANDA) for approval of a generic equivalent of modafinil, the active ingredient contained in PROVIGIL(R) Tablets [C-IV], from a paragraph IV certification to a paragraph III certification.
The effect of this conversion is that Sandoz will certify to the U.S. Food and Drug Administration (FDA) that it does not intend to market a generic form of modafinil until the applicable patent for modafinil listed in the Orange Book has expired in 2014. Therefore, it will no longer be necessary for Cephalon to continue to pursue its patent infringement litigation against Sandoz.
Separately, Cephalon has learned that the ANDA filing against GABITRIL(R) (tiagabine hydrochloride) Tablets that was posted last month on the FDA website does not challenge the composition of matter patent covering the currently approved product. GABITRIL is protected by four Orange Book-listed patents, including a composition of matter patent claiming the active drug substance contained in GABITRIL.
Cephalon recently received notification from SUN Pharmaceutical Industries Limited that its ANDA is targeting the three other Cephalon patents covering GABITRIL. However, the filing does not include a paragraph IV certification with respect to the composition of matter patent. As such, SUN is not seeking to market a generic form of GABITRIL until after the expiration of this patent in 2011.
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