Taft Paves the Way for Generic Prostate Cancer Drug

Taft Pharmaceutical & Life Sciences attorneys Andrew Alul and Roshan Shrestha achieved a win for client Apotex in connection with Apotex’s Abbreviated New Drug Application seeking approval from the U.S. Food and Drug Administration to market a lower-priced, generic alternative to the prostate cancer drug Jevtana® (cabazitaxel) Injection, currently exclusively marketed in the United States by the brand drug company Sanofi. In Sanofi-Aventis U.S. LLC et al. v. Fresenius Kabi USA, LLC et al., No. 3:14-cv-7869-MAS-LHG (D.N.J.) (consolidated), Sanofi sued Apotex and several other generic drug companies also seeking to market generic cabazitaxel products, alleging infringement of Sanofi’s patents covering Jevtana®. After an eight-day bench trial in the United States District Court for the District of New Jersey, District Judge Michael Shipp found the asserted claims of Sanofi’s later-expiring method of treatment patent, U.S. Patent No. 8,927,592, invalid, paving the way for early approval and market entry of Apotex’s generic cabazitaxel product.

In This Article

You May Also Like