Mesalamine (Lialda) – USA

Mesalamine (Lialda) – USA

On Sept 16, 2016, Circuit Judge Jordan (Delaware) issued a one-page order announcing a decision that favors Zydus. More specifically, the court decided that Shire had failed to prove Zydus’s generic tablets would infringe that patent.

There is only one patent directed to Lialda listed in the Orange Book: U.S. Patent No. 6,773,720 (set to expire June 8, 2020). The ’720 patent covers “controlled-release” oral mesalamine formulations that include (1) an “inner lipophilic matrix consisting of substances selected from the group consisting of unsaturated and/or hydrogenated fatty acid, salts, esters or amides thereof, fatty acid mono-, di- or triglycerides, waxes, ceramides, and cholesterol derivatives with melting points below 90° C” and (2) “an outer hydrophilic matrix wherein the inner lipophilic matrix is dispersed” that “consists of” other listed substances. The ’720 patent further requires that mesalamine (3) constitute between 80 and 95% by weight of the total composition and (4) be “dispersed” in both the lipophilic and hydrophilic matrices.

Shire is also pursuing patent infringement litigation against other players like Actavis (now a subsidiary of Teva), Mylan, Osmotica, Amneal, and Lupin.
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