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| GORX > SEC Filings for GORX > Form 8-K on 20-Jan-2009 | All Recent SEC Filings |
20-Jan-2009
Entry into a Material Definitive Agreement, Financial Statements and Exhibits
On January 15, 2009, GeoPharma, Inc. (the "Company") reached an agreement with the Schering Corporation ("Schering"), and Sepracor, Inc. and the University of Massachusetts (collectively, "Sepracor") settling all Hatch-Waxman litigation relating to Desloratadine tablets (5 mg), with the Company receiving a license under all relevant patents.
The agreement provides for potential modification of select terms based on certain events and developments. The specific financial terms and conditions of the agreement have not been disclosed due to confidentiality obligations agreed to by the parties. The agreement is subject to review by the United States Federal Trade Commission and Department of Justice.
The Company had earlier filed a Paragraph IV certification to, among others, U.S. Patent Nos. 6,100,274, 7,214,683 and 7,214,684, contesting that these patents were either invalid or had not been infringed upon, which resulted in the subsequent litigation by Schering and Sepracor.
Under the terms of the settlement, the Company can commercially launch its generic Desloratadine product, with 6 months marketing co-exclusivity, on July 1, 2012, or earlier in certain circumstances. The new product launch may be a prescription or over-the-counter (OTC) product depending on its status at the time of launch. The Company's product is pending FDA approval and seeks an AB-rating as equivalent to Schering's Clarinex® tablets indicated for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis.
(c) Exhibits. The following documents are filed as exhibits to this report:
99.1 Press release issued January 20, 2009.
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