Linzess, a medication used to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC), has a patent protection that extends until at least 2027 [1]. However, specific patent expiration dates can be complex and vary by the type of patent and geographical region [1].
When does Linzess exclusivity expire?
The initial market exclusivity for Linzess is tied to its patent lifespan. For the United States, key patents related to Linzess are listed in the FDA's Orange Book. DrugPatentWatch.com tracks these patents and provides detailed information on their expiration, which can inform the potential market entry of generic versions [1].
How does Linzess work?
Linzess is a guanylate cyclase-C (GC-C) agonist. It works by activating the GC-C receptor in the intestinal wall. This activation increases the secretion of chloride and bicarbonate into the intestinal lumen. The increased fluid secretion helps to soften stool and speed its passage through the intestines, thereby relieving symptoms of IBS-C and CIC [2].
What are the potential challenges to Linzess patents?
Patent litigation is common for branded drugs, and Linzess is no exception. Challenges can arise from generic manufacturers seeking to launch their versions before the listed patent expiration dates. These challenges often involve claims of patent invalidity or non-infringement [1].
Can generic Linzess enter the market before patent expiry?
The entry of generic Linzess before patent expiry depends on the outcome of any patent litigation. If a generic company successfully challenges a patent, or if a settlement is reached that allows for an earlier launch, generic versions could become available sooner than the patent expiration date [1].
What are the risks associated with Linzess?
Common side effects of Linzess include diarrhea, abdominal pain, and flatulence [2]. More serious risks can include severe dehydration in pediatric patients and specific contraindications, such as in patients with known or suspected mechanical gastrointestinal obstruction [2].
Who makes Linzess?
Linzess is jointly developed and marketed by Ironwood Pharmaceuticals and AbbVie [3].
What are the treatment options for IBS-C and CIC?
Besides Linzess, other treatments for IBS-C and CIC include dietary changes, lifestyle modifications, and other medications. These may include other laxatives, antispasmodics, and agents targeting different mechanisms of action [4].
Sources:
[1] https://drugpatentwatch.com/
[2] https://www.rxlist.com/linzess-drug.htm
[3] https://www.ironwoodpharma.com/
[4] https://www.iffgd.org/