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    

MYLAN INC
Mes dernières consult.
Most popular
SummaryNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
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
10/18 ALLERGAN : ruling casts doubt on tribal patent strategy
10/17 MYLAN : to Report Third Quarter 2017 Financial Results on Nov. 6, 2017
10/17 MYLAN : Invalidates Allergan's Patents on Restasis®
10/05 MYLAN : in Partnership with Synthon, Receives Marketing Authorization Approval i..
10/05 MYLAN NV : Mylan, Approval of Copaxone Should Provide an Accretive Boost, Generi..
10/05 MYLAN : Launches First AP-rated Generic Avelox® Injection
10/05 MYLAN : Confirms U.S. Launch of First Generic for Copaxone® 40 mg/mL 3-Times-a-W..
10/04 MYLAN : Provides Support for U.S. Disaster-Relief Efforts
10/04 MYLAN : Announces U.S. FDA Approval of First Generic for Copaxone® 40 mg/mL 3-Ti..
10/02 MYLAN : Launches Generic Cancidas® for Injection
More news
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 2017 12 073 M
EBIT 2017 3 324 M
Net income 2017 1 314 M
Debt 2017 13 503 M
Yield 2017 -
P/E ratio 2017 14,04
P/E ratio 2018 10,87
EV / Sales 2017 2,82x
EV / Sales 2018 2,51x
Capitalization 20 534 M
Income Statement Evolution
Consensus
 
Mean consensus OUTPERFORM
Number of Analysts 20
Average target price 42,0 $
Spread / Average Target 9,7%
EPS Revisions
Managers
NameTitle
Heather M. Bresch Chief Executive Officer & Director
Rajiv Malik President & Director
Robert J. Coury Executive Chairman
Kenneth Scott Parks Chief Financial Officer
Wendy Cameron Independent Non-Executive Director
Sector and Competitors
1st jan.Capitalization (M$)
MYLAN INC20 116
JOHNSON & JOHNSON23.29%377 585
NOVARTIS13.50%226 453
ROCHE HOLDING LTD.5.55%215 760
PFIZER11.58%213 372
MERCK AND COMPANY7.88%173 214