Perrigo' (PRGO) Partner Files Generic Version of Xyzal; Sepracor (SEPR) Files Patent Infringment Suit
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Perrigo Company (Nasdaq: PRGO) announced that its partner Synthon Pharmaceuticals, Inc. has filed an Abbreviated New Drug Application (ANDA) for Levocetirizine solution 2.5mg/5ml, a generic version of Xyzal solution 2.5mg/5ml.
Under terms of an exclusive agreement between the companies, Perrigo has sales and marketing rights in Synthon's Levocetirizine products. The Company believes that Synthon is the first to file an ANDA with a Paragraph IV certification against Xyzal(R) solution that can entitle it to 180 days of generic exclusivity upon approval.
Synthon filed its ANDA for Levocetirizine solution 2.5 mg/5ml containing a Paragraph IV Certification with the U.S. Food & Drug Administration and notified UCB Inc., the New Drug Application holder for Xyzal(R) solution and Sepracor Inc., the listed patent owner, of its filing. On June 17, 2009, Sepracor (Nasdaq: SEPR) and UCB filed suit alleging patent infringement in the United States District Court for the Eastern District of North Carolina against Synthon.
Perrigo Company, through its subsidiaries, develops, manufactures, and distributes over-the-counter (OTC) and prescription (Rx) pharmaceuticals, nutritional products, active pharmaceutical ingredients (API), and consumer products worldwide. [SM]
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