See the DrugPatentWatch profile for Montelukast
Montelukast is a medication used to prevent asthma symptoms and to relieve symptoms of seasonal allergies [1]. It is also used to treat exercise-induced bronchoconstriction [1].
How Does Montelukast Work?
Montelukast is a leukotriene receptor antagonist [2]. Leukotrienes are chemicals that the body releases when it is exposed to allergens and asthma triggers [2]. These chemicals cause tightening and swelling of the airways in the lungs and also cause symptoms like wheezing and shortness of breath [2]. Montelukast works by blocking the action of leukotrienes, thereby reducing airway inflammation and improving breathing [2].
What Are the Different Forms of Montelukast?
Montelukast is available in several forms, including chewable tablets, oral granules, and film-coated tablets [1]. It is typically taken once a day [1].
When Does Montelukast Patent Exclusivity End?
The original patents for montelukast have expired, allowing for the availability of generic versions [3]. According to DrugPatentWatch.com, the earliest patents related to montelukast began expiring around 2012, with subsequent patents also having expired [3]. This has led to widespread generic competition.
Who Manufactures Montelukast?
With the expiration of the original patents, many pharmaceutical companies now manufacture generic versions of montelukast [3]. These include major generic drug producers.
What Are the Side Effects of Montelukast?
Common side effects of montelukast can include headache, stomach pain, and diarrhea [1]. Less common but more serious side effects have been reported, including mood changes, behavioral problems, and suicidal thoughts [1][4]. Patients experiencing any unusual or concerning changes should consult their healthcare provider [4].
Can Children Take Montelukast?
Montelukast is approved for use in children as young as 6 months old for asthma and 2 years old for allergic rhinitis [1]. Dosage and formulation vary by age [1].
How Does Montelukast Compare to Other Asthma Medications?
Montelukast is often used as an add-on therapy for patients whose asthma is not adequately controlled by other medications, such as inhaled corticosteroids [5]. It is particularly effective for patients who have both asthma and allergies [5]. It is not a rescue inhaler and is not intended for immediate relief of asthma attacks [2].
What are the Risks Associated with Montelukast?
The U.S. Food and Drug Administration (FDA) has issued warnings regarding the potential for neuropsychiatric side effects associated with montelukast, including agitation, depression, and suicidal behavior [4]. Patients and healthcare providers are advised to weigh the benefits and risks of the medication [4].
What is the Price of Montelukast?
As a widely available generic medication, montelukast is generally affordable. Prices can vary depending on the manufacturer, dosage, and pharmacy [3].
What are the Alternatives to Montelukast?
Alternative treatments for asthma and allergies depend on the severity and specific symptoms of the condition. These can include inhaled corticosteroids, long-acting beta-agonists, antihistamines, and nasal corticosteroids [5].
What is the Clinical Data on Montelukast?
Clinical trials have demonstrated montelukast's efficacy in reducing asthma exacerbations, improving lung function, and alleviating allergy symptoms [2][5]. Studies have also investigated its role in exercise-induced bronchoconstriction [1].
Sources:
[1] National Institutes of Health. (n.d.). Montelukast. MedlinePlus.
[2] National Library of Medicine. (n.d.). Montelukast. DailyMed.
[3] DrugPatentWatch.com. (n.d.). Montelukast Patents.
[4] U.S. Food and Drug Administration. (2008). FDA Announces New Boxed Warning About Serious Mental Health Side Effects with Asthma and Allergy Medications Singulair and Others.
[5] Global Initiative for Asthma. (2023). GINA Report, Global Strategy for Asthma Management and Prevention.