Lotus Pharmaceuticals Co (美時化學製藥) on Tuesday said it has successfully challenged a patent claim that has been blocking the company’s efforts to commercialize a generic drug.
The US District Court for the District of Delaware ruled that a final remaining patent covering Uceris, a US brand name for an ulcerative colitis drug based on budesonide, was not infringed upon by Lotus, the company said.
The court challenge was overseen by US-based drugmaker Alvogen Group Inc, Lotus said in a statement.
Alvogen and Lotus are to file an abbreviated new drug application with the US Food and Drug Administration for a generic version of Uceris, while Alvogen is prepared to contest appeals by Valeant Pharmaceuticals International Inc, owner of the drug’s original developer.
The dispute began in February 2015, when Alvogen was sued by Salix Pharmaceuticals Inc, the original developer of Uceris, for filing a paragraph IV challenge to certify that patents protecting the drug are invalid and unenforceable.
The dispute continued after Salix was in April 2015 acquired by Valeant, which took over the rights to market Uceris.
The agency could grant Alvogen and Lotus approval at the end of a 180-day exclusivity period granted to Teva Pharmaceutical Industries Ltd, which was the first company to file a generic variant of the drug, Lotus said.
Over the past 12 months, Uceris, which as yet has no generic competitors in the US, commanded a market valued at about US$200 million in that country, Lotus said, citing findings by healthcare researcher IMS Health Inc.
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