Somaxon Pharmaceuticals, Inc. SOMX -3.70% , a specialty pharmaceutical company, today announced that it has entered into separate settlement arrangements with Mylan Inc. and its subsidiary, Mylan Pharmaceuticals, Inc. and Par Pharmaceutical Companies, Inc. and its subsidiary Par Pharmaceutical, Inc. to resolve pending patent litigation involving Silenor(R) 3 mg and 6 mg tablets.
The settlement agreement with Mylan grants Mylan the exclusive right to begin selling an authorized generic version of Silenor (i.e., a generic version sold under Somaxon's New Drug Application) on January 1, 2020, or earlier under certain circumstances. Mylan's right to sell such an authorized generic product could extend for a period of as long as 360 days, and after such period Mylan will have the non-exclusive right to sell a generic version of Silenor under its Abbreviated New Drug Application. In connection with the settlement agreement, the parties also entered into a supply agreement under which Mylan has agreed to supply the company with commercial quantities of Silenor 3 mg and 6 mg tablets.
The settlement agreement with Par grants Par the right to begin selling a generic version of Silenor 180 days after the earlier of the date that a third party's generic version of Silenor is first sold in the United States under a license from Somaxon or a final court decision that the asserted patents are not infringed, invalid or unenforceable, or earlier under certain circumstances.
Each of the settlement agreements will become effective upon the entry by the U.S. District Court for the District of Delaware of an order dismissing the litigation with respect to Mylan or Par, as applicable.
"These settlement agreements reflect our continued confidence in the strength of our Silenor patents and allow us to more confidently devote resources to building the Silenor brand," said Richard W. Pascoe, Somaxon's President and Chief Executive Officer. "We will continue to defend Silenor's intellectual property against the remaining generic challengers with the goal of protecting its market exclusivity while allowing us to minimize further uncertainty and the cost of litigation. We believe that with the evolving clarity on Silenor's exclusivity and revenue, we are well positioned to continue to work with our advisor, Stifel Nicolaus Weisel, to evaluate strategic alternatives with the objective of fully leveraging Silenor for the benefit of our stockholders."
Financial Guidance
Somaxon estimates net product sales for Silenor for the second quarter ended June 30, 2012 to be approximately $2.8 to $2.9 million.
Actual financial results for the second quarter of 2012 could vary based upon many factors, including but not limited to changes in actual Silenor sales and actual levels of sales discounts and allowances.
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