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 US9708371 Treatments for gastrointestinal disorders Aug 16, 2033 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 US10675325 Stable formulations of linaclotide Aug 11, 2031 Abbvie
Linzess US10702576 Stable formulations of linaclotide Aug 11, 2031 Abbvie
Linzess US8933030 Treatments for gastrointestinal disorders Feb 17, 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



Linaclotide's Family Patents

Family Patents

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Linaclotide Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


1. 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


Manufacturing Plant Locations
New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Sangareddy Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





2. 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


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Rockford Mylan Institutional, Inc.
Saint Albans Mylan Technologies, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Morgantown Mylan Specialty, L.P.
Greensboro Mylan Pharmaceuticals Inc
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
San Carlos Mylan Pharmaceuticals Inc.
India
Hyderabad Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Anekal Taluk, Bangalore Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta