Linzess Lawsuits - Current Status and Outlook

What is Linzess?

Linzess, also known as linaclotide, is a prescription drug developed by Ironwood Pharmaceuticals and Allergan. It was approved by the Food and Drug Administration (FDA) in 2012 for the treatment of Irritable Bowel Syndrome (IBS) and Chronic Idiopathic Constipation.

What are the uses and side effects of Linzess?

Patients most often use Linzess or Linaclotide to treat constipation and the pain caused by constipation. The most common side effect of using Linzess is diarrhea which can sometimes be severe. Additionally, other side effects include flatulence, bloating, swelling and stomach pain.

The constipation and belly pain feel like a knot. How can I ease this pain? When I can’t go, it’s like bricks piling up. I wish I could find some relief.

As your doctor about Linzess, a once daily capsule for adults with Irritable Bowel Syndrome (IBS) with constipation or Chronic Idiopathic Constipation. Linzess is thought to help calm pain-sensing nerves and accelerate bowel movements. It helps you proactively manage your symptoms. Do not give Linzess to children under 6, and it should not be given to children 6 to 17 — it may harm them. Don’t take Linzess if you have a bowel blockage. Get immediate help if you develop unusual or severe stomach pain, especially with bloody or black stools. The most common side effect is diarrhea, sometimes severe. If it’s severe, stop taking Linzess and call your doctor right away. Other side effects include gas, stomach pain and swelling.

Bottom line — ask your doctor about Linzess today.

Have there been any Linzess lawsuits?

Despite being on the market for over a decade, as of 2023, there have been no lawsuits related to side effects or complications from using Linzess. However, there have been legal developments concerning the drug’s patent and the introduction of generic versions.

In 2023, Ironwood Pharmaceuticals and Allergan reached an agreement with Sandoz Inc., a company that was seeking approval to market generic versions of Linzess before the expiration of the applicable patents. The litigation, which had been initiated in response to Sandoz’s abbreviated new drug application (ANDA), was resolved through a settlement. As part of the settlement, Ironwood and Allergan agreed to grant Sandoz a license to market its 145 mcg and 290 mcg generic versions of Linzess in the United States starting from February 5, 2030, subject to U.S. FDA approval. This agreement marked the fourth patent infringement settlement the companies have reached with respect to Linzess, thereby safeguarding the patent rights of the drug’s manufacturers.

In the same year, another significant settlement was reached with Teva Pharmaceuticals, USA. This lawsuit was also related to patent infringement due to Teva’s ANDA for marketing generic versions of Linzess. The settlement does not grant any license to Teva with regard to its 72 mcg generic version of Linzess. As part of this agreement, Ironwood and Allergan will grant Teva a license to market its 145 mcg and 290 mcg generic version of Linzess in the United States starting from March 31, 2029, again subject to U.S. FDA approval.

These settlements are significant in the context of the pharmaceutical industry and represent the resolution of the last of the remaining defendants in this patent infringement litigation with respect to Linzess. By reaching these agreements, the manufacturers of Linzess have protected their patent rights and established clear guidelines for the marketing of generic versions of the drug in the future.

While the use of Linzess has not resulted in any known lawsuits related to side effects, it’s always important for patients to discuss potential risks and benefits with their healthcare providers before starting a new medication. As we continue to monitor the legal landscape surrounding Linzess, we’ll provide updates on any new developments. If you believe you’ve experienced adverse effects from Linzess or any other medication, don’t hesitate to reach out to a legal professional for advice.

Want to learn more about Linzess?

Here are some sites you should visit to learn more about Linzess: