Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 
OFFON

4-Traders Homepage  >  Equities  >  Nasdaq  >  Mylan Inc    

SummaryChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector newsTweets 

Mylan Seeks To Overturn FDA's Provigil Decision

share with twitter share with LinkedIn share with facebook
share via e-mail
0
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; [email protected] 

Stocks mentioned in the article : Mylan Inc.
share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on MYLAN INC
04/27 MYLAN : to Report First Quarter 2017 Financial Results on May 10, 2017
04/26 New GlaxoSmithKline CEO wants fewer, bigger new drug launches
04/21 Teva's new asthma inhaler poses first competition for GSK's Advair
04/20 MYLAN : Launches Generic Trilafon Tablets
04/04 MYLAN NV : Today's Research Reports on Stocks to Watch: Mylan and Pfizer
04/03 HAGENS BERMAN : EpiPen Purchasers Accuse Drug Maker Mylan of Fraud, RICO Enterpr..
03/31 MYLAN : Provides Update on Meridian Medical Technologies', a Pfizer Company, Exp..
03/29 MYLAN : Completes Acquisition of Cold-EEZE® Brand
03/29 MYLAN : Comments on Generic Advair Diskus® Abbreviated New Drug Application
03/29 FDA, Mylan silence on generic Advair may be good news for GSK
More news
Sector news : Pharmaceuticals - NEC
04/30DJPFIZER : Drug Makers Take Page From Hollywood to Spread the Risk
04/28DJBRISTOL MYERS SQUIBB : China Approves Bristol-Myers Dual-Drug Hepatitis C Treatm..
04/28DJBRISTOL MYERS SQUIBB : China Approves Bristol-Myers Squibb's Dual-Drug Hepatitis..
04/28 REGENERON PHARMACEUTICALS : Sanofi beats profit forecasts, upbeat on prospects f..
04/28DJSanofi 1st-Quarter Net Profit Rises on Sale of Animal-Health Unit
More sector news : Pharmaceuticals - NEC
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
Advertisement
Financials ($)
Sales 2017 12 795 M
EBIT 2017 3 777 M
Net income 2017 2 085 M
Debt 2017 12 079 M
Yield 2017 -
P/E ratio 2017 13,02
P/E ratio 2018 11,09
EV / Sales 2017 2,51x
EV / Sales 2018 2,28x
Capitalization 20 001 M
More Financials
Chart MYLAN INC
Duration : Period :
Mylan Inc Technical Analysis Chart | US6285301072 | 4-Traders
Full-screen chart
Income Statement Evolution
More Financials
Consensus 
Mean consensus OUTPERFORM
Number of Analysts 20
Average target price 51,2 $
Spread / Average Target 37%
Consensus details
EPS Revisions
More Estimates Revisions
Managers
NameTitle
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
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
MYLAN INC-1.66%20 001
JOHNSON & JOHNSON7.17%334 714
ROCHE HOLDING LTD.11.91%225 722
NOVARTIS AG3.31%202 360
PFIZER INC.4.43%201 998
MERCK & CO., INC.5.88%170 880
More Results