Horizon Pharma, Inc. (HZNP) recently settled its patent infringement lawsuit with Par Pharmaceutical related to Duexis tablets. Par Pharma was looking to get its generic version of Duexis approved by the U.S. Food and Drug Administration (FDA). Duexis is a fixed-dose combination of ibuprofen and famotidine in a single tablet.
Horizon Pharma and Par Pharma entered into a license agreement under which Par Pharma has been granted a non-exclusive right to market a generic version of Duexis in the U.S. beginning Jan 1, 2023, or earlier under certain circumstances. The companies have also requested the dismissal of the pending patent litigation case filed by Horizon Pharma against Par Pharma for Duexis.
Duexis is approved for providing relief for the signs and symptoms of rheumatoid arthritis (RA) and osteoarthris and decreasing the risk of developing upper gastrointestinal ulcers in patients taking ibuprofen for these indications.
We note that Duexis is a major growth driver for Horizon Pharma. Horizon Pharma reported $13.2 million Duexis annual gross sales for 2012.
Meanwhile, we note that Horizon Pharma’s second approved product, Rayos, is also facing a patent challenge. In Mar 2013, the company was informed that an abbreviated new drug application (ANDA) has been filed by Alvogen Pine Brook, Inc. for a generic version of Rayos.
Rayos is approved for the treatment of RA, polymyalgia rheumatica (PMR), psoriatic arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease and several other conditions. Rayos is marketed outside the U.S. as Lodotra.
Horizon Pharma currently carries a Zacks Rank #4 (Sell). At present, companies which look attractive include Gilead Sciences Inc. (GILD) and Actelion Ltd. (ALIOF) with a Zacks Rank #1 (Strong Buy), and Jazz Pharmaceuticals Public Limited Company (JAZZ) with a Zacks Rank #2 (Buy).
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