Horizon Therapeutics Public Limited Co (fka HZNP)

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Horizon Pharma Files Patent Infringement Lawsuit Against Par Pharmaceutical, Inc. for Filing an ANDA Against DUEXIS(R)
MarketwirePress Release: Horizon Pharma – Wed, Mar 28, 2012 4:28 PM EDT

DEERFIELD, IL--(Marketwire -03/28/12)- Horizon Pharma, Inc. (NASDAQ: HZNP - News) today announced it has filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Par Pharmaceutical, Inc. ("Par") and related to an Abbreviated New Drug Application ("ANDA") that Par filed with the U.S. Food and Drug Administration ("FDA") to market a generic version of DUEXIS® tablets.

The lawsuit claims infringement of Horizon's US patent 8,067,033 that is listed in the FDA's Orange Book and expires July 18, 2026. Horizon received a Paragraph IV Patent Certification from Par on February 15, 2012, advising that Par had filed an ANDA with the FDA for a generic version of DUEXIS® tablets. Par alleged that its generic version of DUEXIS® tablets would not infringe US patent 8,067,033 or the patent is invalid or unenforceable. Par has not advised Horizon as to the timing or status of the FDA's review of its filing, or whether it has complied with FDA requirements for proving bioequivalence. The defendants in the lawsuit are Par Pharmaceutical, Inc. and its parent Par Pharmaceutical Companies, Inc.

Horizon commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving Par's ANDA for 30 months or until a district court decision that is adverse to the patent, whichever may occur earlier.