Horizon Pharma, Inc.
) 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.
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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
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.
) with a Zacks Rank #1 (Strong Buy), and
Jazz Pharmaceuticals Public Limited Company
) with a Zacks Rank #2 (Buy).