Montelukast sodium is a Small Molecule owned by Merck & Co, and is involved in 102 clinical trials, of which 101 were completed, and 1 is ongoing.

Montelukast selectively and competitively blocks the cysteinyl leukotriene 1 (CysLT1) receptor, preventing binding of the inflammatory mediator leukotriene D4 (LTD4). Inhibition of LTD4 activity results in inhibition of leukotriene-mediated inflammatory events including migration of eosinophils and neutrophils; adhesion of leukocytes to vascular endothelium, monocyte and neutrophil aggregation; increased airway edema; increased capillary permeability; and bronchoconstriction.

The revenue for Montelukast sodium is expected to reach a total of $6.1bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Montelukast sodium NPV Report.

Montelukast sodium is currently owned by Merck & Co. Organon is the other company associated in development or marketing of Montelukast sodium.

Montelukast sodium Overview

Montelukast sodium (Singulair / Lukair / Kipres / Viatine / Montelukast / Imvlo / Sparadac / Xaira / Lukasm / Montegen / Montelukast Sodium Prasco / Monte-Air / Airathon) is a quinoline derivative acts as an anti-asthmatic agent. It is formulated as granules, film coated tablets, tablets and chewable tablets for oral route of administration. Montelukast sodium is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma. It is also indicated in the prophylaxis of asthma from 2 years of age and older in which the predominant component is exercise-induced bronchoconstriction, nasal congestion, rhinorrhea, nasal itching, sneezing, nasal congestion upon awakening, difficulty sleeping and nocturnal awakenings, tearing, itching, hyperemia and ocular edema. It can also provide symptomatic relief of seasonal allergic rhinitis. Montelukast tablets are indicated for the treatment of bronchial asthma and allergic rhinitis.

Organon Overview

Organon is a healthcare company. The company discovers and develops biosimilars and medicines. It provides medicines and solutions for various conditions including respiratory, cardiovascular, dermatology, non-opioid pain, women’s health and others. The company’s products include mometasone furoate inhalation powder, follitropin beta injection, alendronate sodium, acetate injection, chorionic gonadotropin and others. It conducts patient assistance and Organon access program, which provide free medicines to individuals. Organon markets its products through a network of distribution channels in domestic and overseas markets. It works in collaboration with pharmaceutical and biopharmaceutical companies to commercialize its products. Organon is headquartered in Jersey City, New Jersey, the US.

The company reported revenues of (US Dollars) US$6,304 million for the fiscal year ended December 2021 (FY2021), a decrease of 3.5% over FY2020. In FY2021, the company’s operating margin was 24.3%, compared to an operating margin of 42.1% in FY2020. In FY2021, the company recorded a net margin of 21.4%, compared to a net margin of 33.1% in FY2020. The company reported revenues of US$1,537 million for the third quarter ended September 2022, a decrease of 3% over the previous quarter.

Quick View – Montelukast sodium

Report Segments
  • Innovator (NME)
Drug Name
  • Montelukast sodium
Administration Pathway
  • Oral
Therapeutic Areas
  • Respiratory
Key Companies
  • Sponsor Company: Merck & Co
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.