Santarus, Inc. recently filed a patent infringement lawsuit against Mylan, Inc. (MYL - Analyst Report) which is looking to launch a generic version of Santarus’ Fenoglide (fenofibrate - 40 mg and 120 mg) tablets. The two listed patents are scheduled to expire in 2024.
Santarus has an exclusive license agreement with Cowen Healthcare Royalty Partners and Shore Therapeutics, Inc. for the commercialization of Fenoglide in the US. Fenoglide is indicated to treat adults with hyperlipidemia, mixed dyslipidemia and hypertriglyceridemia.
Fenoglide revenues for the nine months ending Sep 30, 2012 were $5.6 million.
The filing of the patent infringement lawsuit within 45 days from the date of receipt of notice from Mylan is in line with our expectations. This will ensure that the FDA cannot grant final approval to Mylan’s generic for up to 30 months or the court’s decision, whichever is earlier.
We note that another generic company, Impax Laboratories (IPXL) had also challenged the Fenoglide patent. However, Shore Therapeutics had signed a settlement agreement with Impax regarding the patent infringement litigation. Under the terms of the agreement, Impax was granted a sub-license under which it can start selling its generic version of Fenoglide on Oct 1, 2015 or earlier under some circumstances.
With Fenoglide not being a major contributor to the top-line, we do not expect the news regarding the patent infringement lawsuit to have a major impact on Santarus’ shares.
In fact, we expect investor focus to remain on the commercialization of Uceris and the Zegerid re-launch. Earlier this month, Santarus had gained FDA approval for Uceris for remission in patients suffering from mild-to-moderate ulcerative colitis. Uceris is likely to be launched in Mar 2013.
Santarus carries a Zacks Rank #4 (Sell) while Mylan carries a Zacks Rank #2 (Buy). Right now, Furiex Pharmaceuticals, Inc. and Valeant Pharmaceuticals International, Inc. (VRX - Analyst Report), look more attractive with a Zacks Rank #1 (Strong Buy).