Mesalamine (Lialda) – USA

Mesalamine (Lialda) – USA

On Jan 27, 2017, the U.S. District Court for the Middle District of Florida (Tampa) decided that Shire’s 2020 patent would cover Mylan’s proposed generic tablets. As a result of this decision, the court will issue an injunction that blocks FDA from granting effective approval to Mylan’s ANDA.


Shire is involved in patent infringement litigation with several ANDA filers that are seeking FDA approval to market generic versions of Lialda (mesalamine 1.2 g extended-release tablets) prior to expiration of U.S. Patent No. 6,773,720 (set to expire on June 8, 2020).

In April 2012, Mylan notified Shire that it had filed ANDA with a Para IV certification challenging the ’720 patent. Shire sued Mylan for infringement and trial concluded on Sep 29, 2016. Finally Judge Honeywell decided that Shire proved that Mylan’s generic tablets would infringe the ’720 patent. 
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