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: Orange Book Blog: At the Intersection of Patent Law and FDA Law

Pharma News Briefs

By Aaron Barkoff

• Teva announced last week that it was granted 180-day exclusivity for its generic Kytril injection product (granisetron HCl, 1 mg/mL in 1 mL vials).  Thus, it appears the FDA decided the 180-day exclusivity issue raised in Teva's citizen petition--namely, whether Teva's failure to market its generic product within 30 months of ANDA submission caused forfeiture of its exclusivity.  FDA is expected to release a formal response to Teva's petition in the near future.
• King Pharma and CorePharma settled their patent litigation over generic Skelaxin (metaxalone).  According to this AP story, however, analysts disagreed over the impact of the settlement.
• Taro Pharma and Breckenridge Pharma announced settlements with Novartis of their patent cases concerning generic Trileptal (oxcarbazepine).  According to their press releases, Taro and Breckenridge are sharing 180-day exclusivity for the product.
• Bloomberg published an interesting article earlier this week about the faltering biotechnology industry in China.
• Both Pharmalot and the WSJ Health Blog had posts this week about a Bloomberg story that reported the FDA approved only 19 new drugs last year, the fewest since 1983.
• Pharmalot also posted this week on a new report from Cutting Edge Information entitled "Combating Generics 2008," which found that 66 percent of brand name drug companies do not begin strategizing against generics until at least two years after product launch.

Full post as published by Orange Book Blog: At the Intersection of Patent Law and FDA Law on January 11, 2008 (boomark / email).