drug
linaclotide
Marketedupdated 3mo agoby $ABBV AbbVie Inc.
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 3Protein drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 3 investigational indications.
all catalysts(19)
approval · 19
Aug 30, 2012
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Aug 8, 2013
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Nov 8, 2013
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Jul 1, 2014
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Jul 9, 2014
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Dec 11, 2014
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Jan 5, 2015
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Nov 23, 2015
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Apr 6, 2016
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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May 18, 2016
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Aug 31, 2016
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Jan 6, 2017
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Jan 25, 2017
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Mar 8, 2017
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Sep 22, 2020
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Apr 12, 2021
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Aug 24, 2021
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Jun 12, 2023
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Nov 4, 2025
approval
$ABBV265.97+2.72%
LINZESS (LINACLOTIDE) — FDA approval
linaclotide
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Trials studying linaclotide
- phase2A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide
- phase3A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
- phase3Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
- —Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
- phase3A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation
- phase2A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
- phase3Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
Patent cliff
source: FDA Orange Bookfirst barrier falls
Aug 30, 2026
10 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (30)
- Feb 16, 2034patentUS 9708371*PED
- Feb 16, 2034patentUS 9708371*PED
- Feb 16, 2034patentUS 9708371*PED
- Aug 16, 2033formulationUS 9708371
- Aug 16, 2033formulationUS 9708371
- Aug 16, 2033formulationUS 9708371
- Apr 30, 2032patentUS 8748573*PED
- Apr 30, 2032patentUS 8748573*PED
- Apr 30, 2032patentUS 8802628*PED
- Apr 30, 2032patentUS 8802628*PED
- Feb 11, 2032patentUS 10675325*PED
- Feb 11, 2032patentUS 10702576*PED
- Oct 30, 2031method-of-use (U-1515)US 8748573
- Oct 30, 2031method-of-use (U-4345)US 8748573
- Oct 30, 2031formulationUS 8802628
- Oct 30, 2031formulationUS 8802628
- Aug 17, 2031patentUS 8933030*PED5.0y
- Aug 17, 2031patentUS 8933030*PED5.0y
- Aug 17, 2031patentUS 8933030*PED5.0y
- Aug 11, 2031formulationUS 106753255.0y
- Aug 11, 2031method-of-use (U-3644)US 107025765.0y
- Feb 17, 2031formulationUS 89330304.5y
- Feb 17, 2031formulationUS 89330304.5y
- Feb 17, 2031formulationUS 89330304.5y
- Feb 28, 2027patentUS 7304036*PED192d
- Feb 28, 2027patentUS 7304036*PED192d
- Feb 28, 2027patentUS 7304036*PED192d
- Aug 30, 2026compositionUS 730403610d
- Aug 30, 2026compositionUS 730403610d
- Aug 30, 2026compositionUS 730403610d
FDA exclusivities (4)
- May 4, 2029PEDPediatric (6mo bonus)2.7y
- Nov 4, 2028NPPNew Product (3y)2.2y
- Jun 12, 2026I-921Indication (3y)
- Jun 12, 2026I-921Indication (3y)
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