Linaclotide Patent Expiration

Linaclotide is Used for treating chronic idiopathic constipation, irritable bowel syndrome with constipation in adults, and functional constipation in pediatric patients. It was first introduced by Abbvie Inc in its drug Linzess on Aug 30, 2012. 3 different companies have introduced drugs containing Linaclotide.


Linaclotide Patents

Given below is the list of patents protecting Linaclotide, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Linzess US10675325 Stable formulations of linaclotide Aug 11, 2031 Abbvie
Linzess US10702576 Stable formulations of linaclotide Aug 11, 2031 Abbvie
Linzess US7304036 Methods and compositions for the treatment of gastrointestinal disorders Aug 30, 2026 Abbvie
Linzess US7371727 Methods and compositions for the treatment of gastrointestinal disorders Jan 28, 2024

(Expired)

Abbvie
Linzess US7704947 Methods and compositions for the treatment of gastrointestinal disorders Jan 28, 2024

(Expired)

Abbvie
Linzess US7745409 Methods and compositions for the treatment of gastrointestinal disorders Jan 28, 2024

(Expired)

Abbvie
Linzess US8080526 Methods and compositions for the treatment of gastrointestinal disorders Jan 28, 2024

(Expired)

Abbvie
Linzess US8110553 Methods and compositions for the treatment of gastrointestinal disorders Jan 28, 2024

(Expired)

Abbvie
Linzess US8748573 Formulations comprising linaclotide Oct 30, 2031 Abbvie
Linzess US8802628 Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration Oct 30, 2031 Abbvie
Linzess US8933030 Treatments for gastrointestinal disorders Feb 17, 2031 Abbvie
Linzess US9708371 Treatments for gastrointestinal disorders Aug 16, 2033 Abbvie


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Linaclotide Generics

Several generic applications have been filed for Linaclotide. The first generic version for Linaclotide was by Mylan Pharmaceuticals Inc and was approved on Feb 9, 2021. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Feb 7, 2023.

Given below is the list of companies who have filed for Linaclotide generic.


1. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Linaclotide. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
145MCG capsule Discontinued ORAL N/A Feb 9, 2021
290MCG capsule Discontinued ORAL N/A Feb 9, 2021


2. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Linaclotide. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
145MCG capsule Discontinued ORAL N/A Feb 7, 2023
290MCG capsule Discontinued ORAL N/A Feb 7, 2023