Generic pharmaceuticals giant Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) now faces competition from a generic version of its multiple sclerosis drug Copaxone.
Mylan Pharmaceutical Inc. (Nasdaq: MYL) said today that the US Food and Drug Administration (FDA) accepted for filing Mylan's abbreviated new drug application (ANDA) for Teva's Copaxone (Glatiramer Acetate Injection 20 mg/mL).
Mylan said that it had a license and supply agreement with NATCO Pharma Ltd. which granted Mylan exclusive distribution rights for Glatiramer Acetate pre-filled syringes in the US and all major markets in Europe, Australia, New Zealand, Japan and Canada, with an option to expand into additional territories.
Teva claims that its patent is valid until 2014. A market source told "Globes" that "Teva can defend its patent for another two years but this is a negative development."
Copaxone's sales were a record $682 million in the second quarter of 2009, 21% up on the correspnding quarter of 2008.
Teva's shares fell 3.8% in pre-market trading on Nasdaq, and were down 1.9% on the Tel Aviv Stock Exchange (TASE) today.
Published by Globes [online], Israel business news - www.globes-online.com - on September 14, 2009
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