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Perrigo receives patent challenge for its generic Jublia

Perrigo has confirmed that Valeant Pharmaceuticals North America, Valeant Pharmaceuticals Ireland, Dow Pharmaceuticals Sciences and Kaken Pharmaceuticals initiated patent litigation on Sept. 21, 2018 in the U.S. District Court for the District of New Jersey regarding Perrigo's Abbreviated New Drug Application for efinaconazole topical solution 10%, asserting patents listed in the Orange Book for Jublia.

This action formally initiates the litigation process under the Hatch-Waxman Act.

Jublia (efinaconazole) topical solution 10% is indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes.

The product had a market value of $276 million for the 12 months ended July 2018, according to IQVIA.

“This filing is another example of the hard work done by our R&D and legal teams to develop new generic products that lower the cost of health care for consumers," Perrigo executive vice president and president Rx pharmaceuticals John Wesolowski said in a statement.
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