Lialda is Shire’s second best-performing drug, with worldwide sales last year of $684m (€613m). But a decision by the United States District Court for the District of Delaware on Friday has brought the threat of generic competition one step closer.
The court ruled that a proposed Lialda generic made by Cadila Healthcare subsidiary Zydus Pharmaceuticals does not infringe US Patent No. 6,773,720, the result of a markman ruling issued in July 2015 and the subsequent trial which began earlier this year.
The ‘420 patent claims exclusivity of the composition for controlled-release mesalazine, with the product comprising of an inner lipophilic matrix wherein the active ingredient is dispersed, an outer hydrophilic matrix wherein the lipophilic matrix is dispersed, and the option of other excipients.
“Despite this ruling, Shire believes that the proposed Zydus product infringes the ‘720 patent and will continue to vigorously defend its intellectual property rights,” Shire said in a press release. “Shire has thirty days in which to file an appeal to the Court of Appeals to the Federal Circuit.”
According to the pharma firm, this was one of four patents relating to Lialda which were set to expire in June 2020.
Zydus is just one of a number of generic companies looking to compete against Lialda. Osmotica Pharmaceutical, Mylan, Amneal and Lupin have all submitted ANDAs under the Hatch-Waxman Act seeking permission to market generic versions.
According to Shire’s annual report, the firm uses third party suppliers for both the API and finished formulation of Lialda, with a second source for the finished product manufacturing under development.