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Mylan Confirms Four First-to-File Challenges
Date:3/26/2009

PITTSBURGH, March 26 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced that it and/or a subsidiary have been sued in connection with four separate "first-to-file" Abbreviated New Drug Applications (ANDA) filed with the U.S. Food and Drug Administration (FDA).

Mylan and Alphapharm Pty. Ltd were sued by Sepracor Inc. in the U.S. District Court of New Jersey in connection with the ANDA filing for Eszopiclone Tablets, 1 mg, 2 mg and 3 mg. Eszopiclone Tablets are the generic version of Sepracor's insomnia treatment Lunesta(R) Tablets, which had approximately $796 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health.

Mylan Pharmaceuticals Inc. was sued by OSI Pharmaceuticals Inc., Pfizer Inc. and Genentech Inc. in the U.S. District Court in Delaware in connection with the ANDA filing for Erlotinib Hydrochloride (HCl) Tablets, 25 mg, 100 mg and 150 mg. Erlotinib HCl Tablets are the generic version of OSI Pharmaceuticals' lung cancer treatment Tarceva(R) Tablets, which had approximately $492 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health.

Mylan, Mylan Pharmaceuticals and Matrix Laboratories Limited, in which Mylan owns a majority interest, were sued by Shire Canada Inc., Shire International Licensing B.V. and Shire U.S. Inc. in the U.S. District Court for the Southern District of New York in connection with the ANDA filing for Lanthanum Carbonate Chewable Tablets, 500 mg, 750 mg and 1000 mg. Lanthanum Carbonate Chewable Tablets are the generic version of Shire's kidney disease treatment Fosrenol(R), which had approximately $108 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health.

Mylan Pharmaceuticals was sued by Galderma Laboratories Inc., Galderma Laboratories LP, The R
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SOURCE Mylan Inc.
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Related biology technology :

1. Shire Files Lawsuit Against Mylan for Infringement of FOSRENOL(R) (Lanthanum Carbonate) Patent
2. Mylan Reports Adjusted Diluted EPS of $0.26 for the Quarter Ended Dec. 31, 2008, and Adjusted Diluted EPS of $0.80 for the Year Ended Dec. 31, 2008
3. Shire Receives FOSRENOL Paragraph IV Notice Letters from Barr Laboratories and Mylan
4. Cephalon and Eurand File Patent Infringement Lawsuit Against Mylan Pharmaceuticals and Barr Pharmaceuticals
5. Mylan Reports Adjusted Diluted EPS of $0.23 for the Quarter Ended Sept. 30, 2008
6. Mylan Confirms First-to-File Patent Challenge Relating to Lescol(R)
7. Mylan Launches First Generic Version of Antihypertensive Sular(R) ER in the United States
8. Mylan Announces Final FDA Approval for Ropinirole Hydrochloride Tablets
9. Mylan Announces Amendment to Bystolic(TM) (Nebivolol) Agreement
10. Mylan Announces Final FDA Approval for Balsalazide Disodium Capsules
11. Mylan Announces Tentative FDA Approval for Lamotrigine Tablets
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