On Jan 30, 2017, Judge Sue
Robinson of the U.S. District Court for the District of Delaware issued a
decision in favor of Amneal and declared that Merck’s 2018 patent does not
cover Amneal’s proposed generic (mometasone furoate) nasal spray.
Nasonex (mometasone furoate) is a
corticosteroid that is approved in the form of a 50 mcg metered-dose,
manual-pump nasal spray. Various companies have filed ANDAs with Paragraph IV
certifications seeking FDA approval to market generic mometasone furoate nasal
sprays prior to the expiration of Merck’s U.S. Patent No. 6,127,353 (set to
expire on October 3, 2017, with pediatric exclusivity until April 3, 2018). The
’353 patent covers the monohydrate crystalline form of mometasone furoate.
Merck was also involved in patent
infringement litigation with Apotex (FTF) and Teva previously. The courts
ultimately determined that the ’353 patent does not cover Apotex’s & Teva’s
generic nasal spray.
Merck has appealed the decision
in Teva's case and most likely would appeal this decision also to the U.S. Court
of Appeals for the Federal Circuit.
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