FDAnews Drug Daily Bulletin

Mylan has signed a license and supply agreement with India’s Natco Pharma for a generic version of Teva’s blockbuster multiple sclerosis (MS) drug Copaxone.

Under the terms of the agreement, Mylan will have exclusive distribution rights in the U.S., Europe, Australia, New Zealand, Japan and Canada with an option to expand into other areas. Natco already has commercialized its generic Copaxone (glatiramer acetate) product in India and the Ukraine.

Worldwide sales of the brand drug were more than $1.7 billion in 2007, according to Teva.

Copaxone is approved in 51 countries, including the U.S., Canada, Mexico, Australia, Israel and Europe. It is marketed by a Teva subsidiary in North America and by Teva and sanofi-aventis in Europe. The drug has patent protection in the U.S. until 2014.

Word of the agreement came a day after Mylan subsidiary Genpharm won final FDA approval for its ANDA for zaleplon capsules 5 and 10 mg, a treatment for insomnia.

The capsules are the generic version of King Pharmaceuticals’ Sonata (zaleplon), which had U.S. sales of approximately $88 million for the 12 months ending March 31, based on IMS Health data. Six other companies also have approval to market a generic version of the drug, according to the FDA’s website.