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Mylan Seeks To Overturn FDA's Provigil Decision

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04/05/2012 | 07:10pm CEST

Mylan Inc. (>> Mylan Inc.) said it is seeking to overturn a decision by the U.S. Food and Drug Administration that awarded Teva Pharmaceutical Industries Ltd. (TEVA, TEVA.TV) exclusivity for its generic version of Cephalon Inc.'s wakefulness drug Provigil.

The generic drug maker said Thursday it has filed a lawsuit against the FDA in the U.S. district court for the District of Columbia. Mylan is seeking an immediate court order entitling it to exclusivity as well as immediate approval for its abbreviated new drug application.

Mylan alleges Teva did not maintain valid certifications as a result of its acquisition last year of Cephalon and thus is not entitled to exclusivity based on patent certifications. Mylan also alleges that the FDA should have found Mylan as the sole first filer on one of the patents for Provigil.

Earlier Thursday, Teva said the FDA has decided that Teva is the sole first-to-file for both of Provigil's patents, which entitled the company to 180-day exclusivity. The FDA decided that Cephalon's launch of generic Provigil on March 29 triggered the exclusivity.

In October, the Federal Trade Commission required Teva to sell the rights and assets related to a generic cancer pain drug and a generic muscle relaxant in connection with Teva's acquisition of Cephalon. The FTC agreement also required Teva to enter a supply agreement that allows a competing firm, Par Pharmaceuticals Inc. (PRX), to sell a generic version of Provigil in 2012.

Teva expects Par Pharmaceuticals to launch a second generic product on April 6.

Mylan shares slipped 1.8% to $22.74 in recent trading. The stock is up 5.9% so far this year.

   -By Nathalie Tadena, Dow Jones Newswires; 212-416-3287; nathalie.tadena@dowjones.com 

Stocks mentioned in the article : Mylan Inc.
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News from SeekingAlpha
2015 Mylan (MYL) Heather M. Bresch on Q4 2014 Results - Earnings Call Transcript
2015 Mylan Q4 revenues up 15%, Specialty up 38%
2015 Mylan (MYL) Q4 2014 Results - Earnings Call Webcast
2015 Mylan EPS in-line, beats on revenue
2015 Notable earnings after Monday?s close
Financials ($)
Sales 2016 11 091 M
EBIT 2016 3 157 M
Net income 2016 2 006 M
Debt 2016 10 941 M
Yield 2016 -
P/E ratio 2016 14,47
P/E ratio 2017 9,41
EV / Sales 2016 2,77x
EV / Sales 2017 2,37x
Capitalization 19 802 M
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Mean consensus OUTPERFORM
Number of Analysts 21
Average target price 53,4 $
Spread / Average Target 44%
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Heather M. Bresch Chief Executive Officer & Executive Director
Rajiv Malik President & Executive Director
Robert J. Coury Executive Chairman
Kenneth Scott Parks Chief Financial Officer
Wendy Cameron Independent Non-Executive Director
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