Schwarz Pharma Initiates Legal Action Against TEVA
Teva intends to pursue a generic version of Univasc through the FDA’s "paragraph IV" process. A formulation patent covers Univasc until 2007. This patent is listed in the FDA’s "Orange Book" of approved products.
Schwarz Pharma’s action today initiates the FDA’s 30-month statutory stay of approval, designed to allow for the legal process to be settled prior to FDA taking action on the proposed generic product. Schwarz Pharma is confident the U.S. legal process will confirm the patent, which is valid under U.S. law.
Schwarz Pharma markets moexipril in a number of markets around the world. In the United States, the drug has been marketed since 1995 under the brand name Univasc.
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