Mayne Pharma Alleges Perrigo's Proposed Topical Product Infringes on Lexette Patent

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May 3, 2021
Mayne Pharma LLC is suing generic drug manufacturer Perrigo over alleged infringement of the plaintiff’s patent covering drug product Lexette.
According to Thursday’s complaint filed in the District of Delaware, the plaintiff is the sole assignee of United States Patent No. 10,857,159, entitled “Halobetasol Foam Composition and Method of Use Thereof,” which covers Lexette, a topical used to treat skin conditions such as psoriasis. The U.S. Patent and Trademark Office issued the patent Dec. 8, 2020, to Robert T. Gauthier and James D. Hammer, the complaint noted.
Defendants Perrigo Israel Pharmaceuticals Ltd. and Perrigo Co. PLC filed Abbreviated New Drug Application (ANDA) No. 215266 seeking approval by the U.S. Food and Drug Administration (FDA) to bring 0.05% halobetasol propionate topical foam, a generic version of Lexette, to market, according to the complaint. The plaintiff claimed that by submitting the ANDA, the defendants have stated their intention of manufacturing, selling, and distributing this product in Delaware and other retail locations globally before the expiration of the patent-in-suit.

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