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Re: genisi post# 173010

Tuesday, 06/17/2014 3:55:33 PM

Tuesday, June 17, 2014 3:55:33 PM

Post# of 257454
Teva settles Nuvigil US patent case with all remaining challengers:

http://www.sec.gov/Archives/edgar/data/818686/000130901414000416/exhibit1.htm

The outstanding issue was the ‘570 patent, which was upheld by the US District Court but not yet affirmed by the CAFC.

The settlement is bifurcated according to dosage strength. For the 50mg, 100mg, and 150mg doses, where MYL was the first ANDA filer, MYL can launch in Jun 2016 and all other companies can launch in Dec 2017 (180 days later). (Teva previously settled with MYL on these terms.) For the 100mg and 200mg doses, where ACT was the first ANDA filer, ACT can launch in Jun 2016 and all other companies can launch in Dec 2017 (180 days later).

Teva inherited Nuvgil, a single-isomer formulation of Provigil, in the 2011 acquisition of Cephalon for $6.8B in cash (#msg-62636692).

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