Mannitol Patent Expiration

Mannitol is Used for assessing bronchial hyperresponsiveness in patients over 6 years old without clinically apparent asthma. It was first introduced by B Braun Medical Inc in its drug Mannitol 5% on Approved Prior to Jan 1, 1982. Other drugs containing Mannitol are Resectisol, Mannitol 20% In Plastic Container, Mannitol 10% W/ Dextrose 5% In Distilled Water, Mannitol 10%, Mannitol 15% W/ Dextrose 5% In Sodium Chloride 0.45%, Osmitrol 20% In Water In Plastic Container, Osmitrol 20% In Water, Mannitol 15%, Osmitrol 5% In Water, Mannitol 15% In Plastic Container, Osmitrol 5% In Water In Plastic Container, Osmitrol 15% In Water, Osmitrol 10% In Water In Plastic Container, Resectisol In Plastic Container, Mannitol 10% In Plastic Container, Bronchitol, Osmitrol 10% In Water, Osmitrol 15% In Water In Plastic Container, Mannitol 25%, Mannitol 5% W/ Dextrose 5% In Sodium Chloride 0.12%, Mannitol 5% In Plastic Container, Mannitol 20%, Aridol Kit. 13 different companies have introduced drugs containing Mannitol.


Mannitol Patents

Given below is the list of patents protecting Mannitol, 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
Aridol Kit US5817028 Method and device for the provocation of air passage narrowing and/or the induction of sputum Feb 23, 2015

(Expired)

Pharmaxis Europe



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Clinical Trials

Recent Clinical Trials on Mannitol:

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 Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs Debiopharm International SA NA RECRUITING
(Sep 1, 2026)
PHASE3
Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) University of North Carolina, Chapel Hill NA RECRUITING
(Aug 1, 2026)
PHASE2
Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of PXS-5505 in Patients With Primary, Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis Syntara NA COMPLETED
(Jul 1, 2026)
PHASE1, PHASE2
A Study to Assess TTI-0102 vs Placebo in MELAS Patients Thiogenesis Therapeutics, Inc. NA COMPLETED
(Jul 1, 2026)
PHASE2
A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis The University of Texas Health Science Center, Houston NA RECRUITING
(Jul 1, 2026)
PHASE2
A Dose-ranging Study of TTI-0102 in Adults and Children With Leigh Syndrome Spectrum (LSS) Thiogenesis Therapeutics, Inc. NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
The Effect of Mannitol Volume With Changes in Osmolarity in Traumatic Brain Injury Universitas Diponegoro NA COMPLETED
(Jun 1, 2026)
PHASE3
Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes Stanford University NA COMPLETED
(Jun 1, 2026)
PHASE1
Safety, Tolerability, and Pharmacokinetics of ASCT-83 in Healthy Adults Alcamena Stem Cell Therapeutics NA RECRUITING
(Jun 1, 2026)
PHASE1
Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Vestibular Schwannoma Northwell Health NA SUSPENDED
(May 1, 2026)
PHASE1
Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA Northwell Health NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma Northwell Health NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
A Study of KL590586 in Patients With Advanced Solid Tumors Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM Northwell Health NA RECRUITING
(May 1, 2026)
PHASE3
Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA Northwell Health NA RECRUITING
(Apr 1, 2026)
PHASE2
Phase I Trial of Defactinib and VS-6766. Institute of Cancer Research, United Kingdom NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE1
Safety and Efficacy of AON-D21 in Severe Community-Acquired Pneumonia. Aptarion Biotech AG NA COMPLETED
(Mar 1, 2026)
PHASE2
Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY) NTC srl NA RECRUITING
(Mar 1, 2026)
PHASE3
Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study) Hudson Biotech NA RECRUITING
(Mar 1, 2026)
PHASE2


Mannitol Generic API Manufacturers

Several generic applications have been filed for Mannitol. The first generic version for Mannitol was by Fresenius Kabi Usa Llc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Igi Laboratories Inc and was approved on May 6, 1987.

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


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