Teva Pharmaceutical Industries Ltd. (TEVA) on Thursday said the FDA has decided that its wholly owned subsidiary, Teva Pharmaceuticals USA, is sole first-to-file for both Orange Book patents listed for Provigil (modafinil) and therefore Teva's ANDA alone is entitled to 180-day exclusivity.
Cephalon launched generic Provigil on March 29 and the FDA has also decided that such launch triggered the exclusivity.
Teva expects Par Pharmaceutical to launch a second generic product on April 6 pursuant to the agreement with the FTC in connection with the Cephalon acquisition.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.