Aridol Kit Patent Expiration

Aridol Kit is a drug owned by Pharmaxis Europe Ltd. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 23, 2015. Details of Aridol Kit's patents and their expiration are given in the table below.

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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5817028 Method and device for the provocation of air passage narrowing and/or the induction of sputum
Feb, 2015

(11 years ago)

Expired


FDA has granted several exclusivities to Aridol Kit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Aridol Kit, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Aridol Kit.

Exclusivity Information

Aridol Kit holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Aridol Kit's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Oct 05, 2013

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US patents provide insights into the exclusivity only within the United States, but Aridol Kit is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Aridol Kit's family patents as well as insights into ongoing legal events on those patents.

Aridol Kit's Family Patents


Family Patents

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Clinical Trials

Recent Clinical Trials on Aridol Kit:

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




Generic Launch

Generic Release Date:

Aridol Kit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 23, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Aridol Kit Generic API suppliers:

Mannitol is the generic name for the brand Aridol Kit. 6 different companies have already filed for the generic of Aridol Kit, with Igi Labs Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Aridol Kit's generic





About Aridol Kit

Aridol Kit is a drug owned by Pharmaxis Europe Ltd. It is used for assessing bronchial hyperresponsiveness in patients over 6 years old without clinically apparent asthma. Aridol Kit uses Mannitol as an active ingredient. Aridol Kit was launched by Pharmaxis Europe in 2010.

Approval Date:

Aridol Kit was approved by FDA for market use on 05 October, 2010.

Active Ingredient:

Aridol Kit uses Mannitol as the active ingredient. Check out other Drugs and Companies using Mannitol ingredient

Treatment:

Aridol Kit is used for assessing bronchial hyperresponsiveness in patients over 6 years old without clinically apparent asthma.

Dosage:

Aridol Kit is available in powder form for inhalation use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
N/A,5MG,10MG,20MG,40MG POWDER Prescription INHALATION