Montelukast is available as a generic medication, meaning its brand-name exclusivity has expired. Originally marketed by Merck & Co. under the brand name Singulair, montelukast is now produced by numerous pharmaceutical companies.
What is Montelukast used for?
Montelukast is prescribed to treat asthma and to prevent exercise-induced bronchoconstriction. It is also used to relieve symptoms of allergic rhinitis, such as sneezing, runny nose, stuffy nose, and itchy nose [1].
When did Singulair lose its patent protection?
Singulair's primary patents began to expire around 2010-2012. This allowed generic versions of montelukast to enter the market, significantly reducing its price and increasing accessibility [2].
What are the available generic brands of Montelukast?
Following the patent expiration of Singulair, many generic manufacturers have produced montelukast. These include companies such as Teva Pharmaceuticals, Mylan Pharmaceuticals, Aurobindo Pharma, and others. These generic versions are available in various formulations, including tablets, chewable tablets, and oral granules.
How does generic Montelukast compare to brand-name Singulair?
Generic montelukast is bioequivalent to brand-name Singulair. This means that the generic versions contain the same active ingredient (montelukast sodium), in the same dosage form and strength, and are absorbed into the bloodstream at the same rate and to the same extent [1]. Regulatory agencies like the U.S. Food and Drug Administration (FDA) require generic drugs to meet the same standards of safety and efficacy as their brand-name counterparts.
Why is the cost of Montelukast lower with generic versions?
The cost reduction is a direct result of patent expiry. When a drug is under patent, the original manufacturer holds exclusive marketing rights. Once the patent expires, other companies can produce and sell generic versions, leading to increased competition and lower prices for consumers [2].
What is the mechanism of action for Montelukast?
Montelukast is a selective leukotriene receptor antagonist. It works by blocking the action of leukotrienes, which are chemicals produced by the body that cause narrowing and swelling of the airways and also cause allergy symptoms [1].
Are there any alternatives to Montelukast for asthma or allergies?
For asthma, alternative treatments include inhaled corticosteroids, short-acting beta-agonists, long-acting beta-agonists, and other classes of medication depending on asthma severity. For allergic rhinitis, alternatives include antihistamines, nasal corticosteroids, decongestants, and immunotherapy [3].
What are the common side effects of Montelukast?
Common side effects reported for montelukast include headache, stomach pain, and diarrhea. Less common but more serious side effects have also been reported, including neuropsychiatric events such as mood changes, depression, and suicidal thoughts, though these are rare [1].
Who manufactures Montelukast now?
Numerous pharmaceutical companies manufacture generic montelukast. These include major generic drug producers that supply medications to pharmacies worldwide.
Sources:
[1] U.S. National Library of Medicine. (n.d.). Montelukast. Retrieved from https://medlineplus.gov/druginfo/meds/a601160.html
[2] DrugPatentWatch.com. (n.d.). Montelukast Sodium Patents and Exclusivity. Retrieved from https://www.drugpatentwatch.com/montelukast-sodium/
[3] National Asthma Education and Prevention Program. (n.d.). National Asthma Guidelines. Retrieved from https://www.nhlbi.nih.gov/health/asthma/guidelines