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
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 (Pediatric) | Treatments For Gastrointestinal Disorders | Feb 16, 2034 | Abbvie |
| Linzess | US9708371 | Treatments for gastrointestinal disorders | Aug 16, 2033 | Abbvie |
| Linzess |
US8748573 (Pediatric) | Formulations Comprising Linaclotide | Apr 30, 2032 | Abbvie |
| Linzess |
US8802628 (Pediatric) | Stable Solid Formulation Of A Gc-C Receptor Agonist Polypeptide Suitable For Oral Administration | Apr 30, 2032 | Abbvie |
| Linzess |
US10675325 (Pediatric) | Stable Formulations Of Linaclotide | Feb 11, 2032 | Abbvie |
| Linzess |
US10702576 (Pediatric) | Stable Formulations Of Linaclotide | Feb 11, 2032 | 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 (Pediatric) | Treatments For Gastrointestinal Disorders | Aug 17, 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 (Pediatric) | Methods And Compositions For The Treatment Of Gastrointestinal Disorders | Feb 28, 2027 | Abbvie |
| Linzess | US7304036 | Methods and compositions for the treatment of gastrointestinal disorders |
Aug 30, 2026
(Expired) | 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
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Clinical Trials
Recent Clinical Trials on Linaclotide:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | NA |
ACTIVE NOT RECRUITING
(Jul 1, 2026)
| PHASE2 |
| GCC Agonist Signal in the Small Intestine | University of Wisconsin, Madison | NA |
COMPLETED
(Apr 1, 2026)
| PHASE1 |
| A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation | AbbVie | NA |
COMPLETED
(Apr 1, 2026)
| PHASE3 |