Sotagliflozin Patent Expiration

Sotagliflozin is Used for reducing the risk of cardiovascular events in adults with heart failure, type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors. It was first introduced by Lexicon Pharmaceuticals Inc in its drug Inpefa on May 26, 2023.


Sotagliflozin Patents

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

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Inpefa US8217156 Solid forms of (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol and methods of their use Oct 07, 2030 Lexicon Pharms Inc
Inpefa US8476413 Sulfanyl-tetrahydropyran-based compounds and methods of their use May 29, 2028 Lexicon Pharms Inc
Inpefa US7781577 Inhibitors of sodium glucose co-transporter 2 and methods of their use May 04, 2028 Lexicon Pharms Inc



Sotagliflozin's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Sotagliflozin:

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
Clinical Trials
A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy Lexicon Pharmaceuticals NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring. HealthPartners Institute NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity Icahn School of Medicine at Mount Sinai NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease Alessandro Doria NA RECRUITING
(Mar 1, 2026)
PHASE3


Sotagliflozin Generic API Manufacturers

Given below is the list of companies who have filed for Sotagliflozin generic, along with the locations of their manufacturing plants worldwide.