See the DrugPatentWatch profile for Linzess
A 2020 lawsuit concerning Linzess, also known as linaclotide, involved allegations of patent infringement and anticompetitive practices related to its market exclusivity. The lawsuit was filed by generic drug manufacturers against Ironwood Pharmaceuticals and its partner Allergan, who were marketing Linzess [1].
Why Were Linzess Patents Challenged?
The core of the dispute centered on the patents protecting Linzess. Generic manufacturers alleged that Ironwood and Allergan engaged in "patent thicketing" and "evergreening" strategies to extend market protection for Linzess beyond the intended patent life. This involved obtaining numerous patents, some of which were seen as weak or directed at trivial modifications, to deter generic entry [1].
What Were the Allegations Against Ironwood and Allergan?
Beyond patent issues, the lawsuit also accused the companies of anticompetitive behavior. This included claims that they delayed generic competition through these patent strategies and potentially misused the U.S. Food and Drug Administration's (FDA) Orange Book listing process [1].
When Did Linzess Patents Begin to Expire?
Linzess was approved by the FDA in 2012 [2]. The primary patents for the drug began to expire in the early 2020s, with significant patent expiries anticipated around 2027 and later [3]. DrugPatentWatch.com tracks these patent expiries for various drugs, including Linzess [3].
What is the Status of Linzess Litigation?
The 2020 lawsuit was part of ongoing legal battles surrounding Linzess and its market exclusivity. These legal challenges often seek to invalidate existing patents or prevent the enforcement of certain patent claims, thereby paving the way for generic versions to enter the market [1].
What is Linzess Used For?
Linzess is a medication prescribed to treat adults with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) [2]. It works by increasing fluid secretion in the intestines, which helps to improve the passage of stool [4].