Horizon Pharma, Inc.
HZNP today announced that it has entered into settlement
and license agreements with Par Pharmaceutical Companies, Inc. and
its subsidiary Par Pharmaceutical, Inc., to resolve pending patent
litigation involving DUEXIS(R) (ibuprofen and famotidine) tablets.
Under the license agreement, Horizon has granted Par the
non-exclusive right to market a generic ibuprofen and famotidine
product in the U.S. under Par's Abbreviated New Drug Application
(ANDA), beginning January 1, 2023, or earlier under certain
circumstances. Currently, Horizon has listed six Orange Book patents
covering DUEXIS.
The settlement agreement includes a stipulation by the parties
requesting dismissal without prejudice of the lawsuit filed by
Horizon in the U.S. District Court for the District of Delaware
relating to the ANDA filed by Par with the U.S. Food and Drug
Administration for a generic version of DUEXIS (ibuprofen and
famotidine) tablets.
Details of the settlement are confidential, and the agreements are
subject to submission to the Federal Trade Commission and the U.S.
Department of Justice. The settlement and license agreements will
become effective upon the entry by the U.S. District Court for the
District of Delaware of an order dismissing without prejudice the
litigation with respect to Par.
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