Montelukast

{{Short description|Medication used in asthma or COPD}} {{Use dmy dates|date=August 2025}} {{cs1 config|name-list-style=vanc|display-authors=6}} {{Infobox drug | Watchedfields = changed | verifiedrevid = 462253627 | image = Montelukast.svg | image_class = skin-invert-image | width = 300 | alt = | image2 = Montelukast 3D ball-and-stick.png | image_class2 = bg-transparent | width2 = 250 | alt2 = | caption =

| pronounce = mon te loo' kast | tradename = Singulair, others | Drugs.com = {{drugs.com|monograph|montelukast-sodium}} | MedlinePlus = a600014 | DailyMedID = Montelukast | pregnancy_AU = B1 | pregnancy_AU_comment = <ref name="Drugs.com pregnancy">{{cite web | title=Montelukast (Singulair) Use During Pregnancy | website=Drugs.com | date=13 December 2019 | url=https://www.drugs.com/pregnancy/montelukast.html | access-date=4 March 2020 | archive-date=7 August 2019 | archive-url=https://web.archive.org/web/20190807090808/https://www.drugs.com/pregnancy/montelukast.html | url-status=live }}</ref> | pregnancy_category= | routes_of_administration = By mouth | class = Leukotriene receptor antagonist | ATC_prefix = R03 | ATC_suffix = DC03 | ATC_supplemental =

| legal_AU = S4 | legal_AU_comment = | legal_BR =  | legal_BR_comment = | legal_CA = Rx-only | legal_CA_comment = | legal_DE =  | legal_DE_comment = | legal_NZ =  | legal_NZ_comment = | legal_UK = POM | legal_UK_comment = <ref name="med.org.uk" /> | legal_US = Rx-only | legal_US_comment = <ref name="Singulair FDA label">{{cite web | title=Singulair- montelukast sodium granule Singulair- montelukast sodium tablet, chewable Singulair- montelukast sodium tablet, film coated | website=DailyMed | date=29 April 2020 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8c166755-7711-4df9-d689-8836a1a70885 | access-date=12 October 2020 | archive-date=15 October 2020 | archive-url=https://web.archive.org/web/20201015194847/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8c166755-7711-4df9-d689-8836a1a70885 | url-status=live }}</ref> | legal_EU = | legal_EU_comment = | legal_UN =  | legal_UN_comment = | legal_status =

| bioavailability = 63–73% | protein_bound = 99% | metabolism = Liver (CYP2C8-major, CYP3A4 and CYP2C9-minor)<ref name="med.org.uk"/> | metabolites = | onset = | elimination_half-life = 2.7–5.5 hours <ref name="Elseviers Healthcare Hub 2020">{{cite web | title=Elsevier – Drug Monograph │Montelukast | website=Elsevier's Healthcare Hub | date=4 March 2020 | url=https://elsevier.health/en-US/preview/montelukast#pharmacokinetics | access-date=27 January 2023 | quote=Montelukast and its metabolites are excreted almost exclusively via the bile; less than 0.2% of the drug is excreted in urine. Mean elimination half-life (half-life) of montelukast is 2.7 to 5.5 hours in healthy young adults. | archive-date=27 January 2023 | archive-url=https://web.archive.org/web/20230127095358/https://elsevier.health/en-US/preview/montelukast#pharmacokinetics | url-status=live }}</ref> | duration_of_action = | excretion = Bile duct<ref name="Elseviers Healthcare Hub 2020"/>

| index2_label = as salt | CAS_number_Ref = {{cascite|correct|??}} | CAS_number = 158966-92-8 | CAS_supplemental = | PubChem = 5281040 | IUPHAR_ligand = 3340 | DrugBank_Ref = {{drugbankcite|correct|drugbank}} | DrugBank = DB00471 | ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}} | ChemSpiderID = 4444507 | UNII_Ref = {{fdacite|correct|FDA}} | UNII = MHM278SD3E | KEGG_Ref = {{keggcite|correct|kegg}} | KEGG = D08229 | KEGG2_Ref = {{keggcite|correct|kegg}} | KEGG2 = D00529 | ChEBI_Ref = {{ebicite|correct|EBI}} | ChEBI = 50730 | ChEMBL_Ref = {{ebicite|correct|EBI}} | ChEMBL = 787 | NIAID_ChemDB = | PDB_ligand = | synonyms =

| IUPAC_name = (''E'',''Z'')-2-(1-((1-(3-(2-(7-Chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetic acid | C=35 | H=36 | Cl=1 | N=1 | O=3 | S=1 | SMILES = O=C(O)CC1(CC1)CS[C@@H](c2cccc(c2)\C=C\c3nc4cc(Cl)ccc4cc3)CCc5ccccc5C(O)(C)C | StdInChI_Ref = {{stdinchicite|correct|chemspider}} | StdInChI = 1S/C35H36ClNO3S/c1-34(2,40)30-9-4-3-7-25(30)13-17-32(41-23-35(18-19-35)22-33(38)39)27-8-5-6-24(20-27)10-15-29-16-12-26-11-14-28(36)21-31(26)37-29/h3-12,14-16,20-21,32,40H,13,17-19,22-23H2,1-2H3,(H,38,39)/b15-10+/t32-/m1/s1 | StdInChI_comment = | StdInChIKey_Ref = {{stdinchicite|correct|chemspider}} | StdInChIKey = UCHDWCPVSPXUMX-TZIWLTJVSA-N | density = | density_notes = | melting_point = 145 | melting_high = 148 | melting_notes = | boiling_point = | boiling_notes = | solubility = | sol_units = | specific_rotation = }}

'''Montelukast''', sold under the brand name '''Singulair''' among others, is a medication used in the maintenance treatment of asthma.<ref name=AHFS2018/> It is generally less preferred for this use than inhaled corticosteroids.<ref name=AHFS2018/> It is not useful for acute asthma attacks.<ref name=AHFS2018/> Other uses include allergic rhinitis and hives of long duration.<ref name=AHFS2018/> For allergic rhinitis it is a second-line treatment.<ref name="Grainger Drake-Lee 2006 pp. 360–367">{{cite journal | vauthors = Grainger J, Drake-Lee A | title = Montelukast in allergic rhinitis: a systematic review and meta-analysis | journal = Clinical Otolaryngology | volume = 31 | issue = 5 | pages = 360–367 | date = October 2006 | pmid = 17014443 | doi = 10.1111/j.1749-4486.2006.01276.x | publisher = Wiley | s2cid = 27200676 }}</ref>

Common side effects include abdominal pain, cough, and headache.<ref name=AHFS2018/> Severe side effects may include allergic reactions, such as anaphylaxis and eosinophilia.<ref name=AHFS2018/> Use in pregnancy appears to be safe.<ref name=AHFS2018/> In 2019, concerns over neuropsychiatric side effects resulted in montelukast receiving a black box warning in the United Kingdom for behavioural changes, depression, and suicidality. Montelukast is in the leukotriene receptor antagonist family of medications.<ref name=AHFS2018/> It works by blocking the action of leukotriene D4 in the lungs resulting in decreased inflammation and relaxation of smooth muscle.<ref name=AHFS2018/>

Montelukast was approved for medical use in the United States in 1998.<ref name=AHFS2018/> It is available as a generic medication.<ref name=BNF76>{{cite book|title=British national formulary: BNF 76|date=2018|publisher=Pharmaceutical Press|isbn=978-0-85711-338-2|page=269|edition=76}}</ref> In 2023, it was the 20th most commonly prescribed medication in the United States, with more than 25{{nbsp}}million prescriptions.<ref name="Top300Drugs">{{cite web | title=Top 300 of 2023 | url=https://clincalc.com/DrugStats/Top300Drugs.aspx | website=ClinCalc | access-date=12 August 2025 | archive-date=12 August 2025 | archive-url=https://web.archive.org/web/20250812130026/https://clincalc.com/DrugStats/Top300Drugs.aspx | url-status=live }}</ref><ref>{{cite web | title = Montelukast Drug Usage Statistics, United States, 2014 - 2023 | website = ClinCalc | url = https://clincalc.com/DrugStats/Drugs/Montelukast | access-date = 12 August 2025 }}</ref>

==Medical uses== Montelukast is used for a number of conditions including asthma, exercise induced bronchospasm, allergic rhinitis, and urticaria.<ref name=AHFS>{{cite web|title=Montelukast Sodium|url=https://www.drugs.com/monograph/montelukast-sodium.html|work=The American Society of Health-System Pharmacists|access-date=3 April 2011|archive-date=7 June 2019|archive-url=https://web.archive.org/web/20190607202202/https://www.drugs.com/monograph/montelukast-sodium.html|url-status=live}}</ref> It is mainly used as a complementary therapy in adults in addition to inhaled corticosteroids, if inhaled steroids alone do not bring the desired effect. It is also used to prevent allergic reactions and asthma flare-ups during the administration of intravenous immunoglobulin. It may also be used as an adjunct therapy in symptomatic treatment of mastocytosis.<ref>{{cite journal | vauthors = Cardet JC, Akin C, Lee MJ | title = Mastocytosis: update on pharmacotherapy and future directions | journal = Expert Opinion on Pharmacotherapy | volume = 14 | issue = 15 | pages = 2033–2045 | date = October 2013 | pmid = 24044484 | pmc = 4362676 | doi = 10.1517/14656566.2013.824424 }}</ref> It is taken by mouth, as a tablet, chewable tablet, or as granules.<ref name=AHFS2018>{{cite web |title=Montelukast Sodium Monograph for Professionals |url=https://www.drugs.com/monograph/montelukast-sodium.html |website=Drugs.com |publisher=AHFS |access-date=23 December 2018 |archive-date=7 June 2019 |archive-url=https://web.archive.org/web/20190607202202/https://www.drugs.com/monograph/montelukast-sodium.html |url-status=live }}</ref>

==Pharmacology== {{main|Leukotriene receptor antagonist}} Montelukast is in the leukotriene receptor antagonist family of medications.<ref name=AHFS2018/> It works by blocking the action of leukotriene D4 in the lungs resulting in decreased inflammation and relaxation of smooth muscle.<ref name=AHFS2018/>

Montelukast functions as a leukotriene receptor antagonist (cysteinyl leukotriene receptors) and consequently opposes the function of these inflammatory mediators; leukotrienes are produced by the immune system and serve to promote bronchoconstriction, inflammation, microvascular permeability, and mucus secretion in asthma and COPD.<ref name="Antileukotriene">{{cite journal | vauthors = Scott JP, Peters-Golden M | title = Antileukotriene agents for the treatment of lung disease | journal = American Journal of Respiratory and Critical Care Medicine | volume = 188 | issue = 5 | pages = 538–544 | date = September 2013 | pmid = 23822826 | doi = 10.1164/rccm.201301-0023PP }}</ref>

==Adverse effects== Common side effects include diarrhea, nausea, vomiting, mild rashes, asymptomatic elevations in liver enzymes, and fever. Uncommon side effects include fatigue and malaise, behavioral changes, paresthesias and seizures, muscle cramps, and nose bleeds. Rare (may affect up to 1 in 10,000 people taking montelukast) but serious side effects include behavioral changes (including suicidal thoughts), angioedema, erythema multiforme, and liver problems.<ref name="med.org.uk" >{{cite web |title=Singulair 10 mg film-coated tablets - Summary of Product Characteristics (SmPC) |website=electronic medicines compendium (emc) |url=https://www.medicines.org.uk/emc/product/198/smpc |access-date=23 December 2018 |archive-date=1 October 2020 |archive-url=https://web.archive.org/web/20201001235029/https://www.medicines.org.uk/emc/product/198/smpc |url-status=live }}</ref><ref>{{cite news|url=https://www.reuters.com/investigates/special-report/usa-lawsuits-merck-singulair/|work=Reuters|title=A son died, his parents tried to sue. How U.S. courts protect Big Pharma|vauthors=Levine D, Respaut R, Cooke K, Spector M, Lesser B|date=26 June 2023|access-date=27 June 2023|archive-date=26 June 2023|archive-url=https://web.archive.org/web/20230626205747/https://www.reuters.com/investigates/special-report/usa-lawsuits-merck-singulair/|url-status=live}}</ref>

In 2019 and 2020, concerns for neuropsychiatric reactions were added to the prescription labels in the United Kingdom and the United States where the most frequently suspected were nightmares, depression, insomnia (may affect between 1 in 100 to 1 in 1,000 people taking montelukast); aggression, anxiety and abnormal behavior or changes in behavior (may affect between 1 in 1,000 and 1 in 10,000 people taking montelukast).<ref name="GOV.UK">{{cite web |title=Montelukast (Singulair): reminder of the risk of neuropsychiatric reactions |url=https://www.gov.uk/drug-safety-update/montelukast-singulair-reminder-of-the-risk-of-neuropsychiatric-reactions |access-date=19 September 2019 |archive-date=24 September 2019 |archive-url=https://web.archive.org/web/20190924144737/https://www.gov.uk/drug-safety-update/montelukast-singulair-reminder-of-the-risk-of-neuropsychiatric-reactions |url-status=live }}</ref><ref name="FDA warning" /><ref>{{cite web | title=Montelukast: reminder of the risk of neuropsychiatric reactions | website=GOV.UK | date=29 April 2024 | url=https://www.gov.uk/drug-safety-update/montelukast-reminder-of-the-risk-of-neuropsychiatric-reactions | access-date=24 November 2024}}</ref><ref>{{cite press release | title=Outcome of MHRA review of neuropsychiatric reactions with montelukast | website=GOV.UK | date=29 April 2024 | url=https://www.gov.uk/government/news/outcome-of-mhra-review-of-neuropsychiatric-reactions-with-montelukast | access-date=24 November 2024}}</ref>

===FDA investigation===

In June 2009, the US Food and Drug Administration (FDA) concluded a review into the possibility of neuropsychiatric side effects with leukotriene modulator drugs.<ref name="FDA safety 20090612" /> Although clinical trials revealed only an increased risk of insomnia, post-marketing surveillance showed that the drugs were associated with a possible increase in suicidal behavior and other side effects such as agitation, aggression, anxiousness, dream abnormalities, hallucinations, depression, irritability, restlessness, and tremor.<ref name="FDA safety 20090612">{{cite web | title=Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) | website=U.S. Food and Drug Administration (FDA) | date=12 June 2009 | url=https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm | archive-url=https://wayback.archive-it.org/7993/20171114124744/https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm | archive-date=14 November 2017 | access-date=1 March 2017 }}</ref>

In March 2020, the FDA required a boxed warning for montelukast to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug in the wake of an increase in case reporting of neuropsychiatric events around the time of the initial communications about the concern from FDA in 2008.<ref name="FDA PR">{{cite press release | title=FDA Requires Stronger Warning About Risk of Neuropsychiatric Events Associated with Asthma and Allergy Medication Singulair and Generic Montelukast | website=U.S. Food and Drug Administration (FDA) | date=4 March 2020 | url=https://www.fda.gov/news-events/press-announcements/fda-requires-stronger-warning-about-risk-neuropsychiatric-events-associated-asthma-and-allergy | access-date=4 March 2020 | archive-date=4 March 2020 | archive-url=https://web.archive.org/web/20200304225341/https://www.fda.gov/news-events/press-announcements/fda-requires-stronger-warning-about-risk-neuropsychiatric-events-associated-asthma-and-allergy | url-status=dead }} {{PD-notice}}</ref><ref name="FDA safety 20200304">{{cite web | title=FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis | website=U.S.Food and Drug Administration (FDA) | date=4 March 2020 | url=https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug | access-date=4 March 2020 | archive-date=4 March 2020 | archive-url=https://web.archive.org/web/20200304225312/https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug | url-status=live }} {{PD-notice}}</ref><ref name="FDA warning">{{cite web | title=Singulair (montelukast) and All Generics: Strengthened Boxed Warning | website=U.S. Food and Drug Administration (FDA) | date=4 March 2020 | url=https://www.fda.gov/safety/medical-product-safety-information/singulair-montelukast-and-all-montelukast-generics-strengthened-boxed-warning-due-restricting-use | access-date=4 March 2020 | archive-date=4 March 2020 | archive-url=https://web.archive.org/web/20200304225837/https://www.fda.gov/safety/medical-product-safety-information/singulair-montelukast-and-all-montelukast-generics-strengthened-boxed-warning-due-restricting-use | url-status=dead }} {{PD-notice}}</ref> The boxed warning advises health care providers to avoid prescribing montelukast to patients with mild symptoms, particularly those with allergic rhinitis, because there are many other allergy medicines that can safely and effectively manage this condition.<ref name="FDA PR" />

In the FDA's data analysis, in comparison to case reports that based on people's self-reports, the propensity of developing neuropsychiatric disorders after montelukast use did not outpace that of inhaled corticosteroids; and there were no statistically significant risks of new-onset neuropsychiatric disorders among males, females, patients 12 years and older, patients with a psychiatric history, or after the 2008 FDA communication and prescribing information changes that first publicized the concern.<ref name="FDA safety 20200304" /> In addition, the FDA's analysis summary of its findings said "exposure to montelukast was significantly associated with a decreased risk of treated outpatient depressive disorder and the decreased risks were seen among patients with a history of a psychiatric disorder, in patients 12 to 17 years as well as 18 years and older, and in both females and males."<ref name="FDA safety 20200304" /> "Treated outpatient depressive disorder" refers to patients who sought treatment specifically for depressive disorders in outpatient psychiatric settings.<ref name="FDA safety 20200304" />

In 2024, following reports of night terrors, uncontrollable aggression, intrusive thoughts, depression and rare cases of hallucinations and suicidal behavior in children, the UK Medicines and Healthcare products Regulatory Agency (MHRA) was reviewing the risks of montelukast after identifying "further concerns".<ref>{{cite news | vauthors = Ungoed-Thomas J | title=Safety fears over asthma drug after young children suffer severe side effects |newspaper=\The Observer| date=3 March 2024 | url=https://www.theguardian.com/society/2024/mar/03/safety-fears-over-asthma-drug-after-young-children-suffer-severe-side-effects}}</ref> The FDA has begun, as of 2020, an internal expert review of why the drug may cause "neuropsychiatric side effects".<ref name=":0">{{Cite web | vauthors = Levine D, Dang S |date=22 November 2024 |title=Exclusive: US FDA finds widely used asthma drug impacts the brain |url=https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-finds-widely-used-asthma-drug-impacts-brain-2024-11-22/ |access-date=24 November 2024 |website=Reuters}}</ref>

In a limited audience review of some findings of this internal group to the American College of Toxicology, on 20 November 2024 in Austin, Texas, Jessica Oliphant, deputy director for FDA's National Center for Toxicological Research, said "that laboratory tests showed “significant binding” of montelukast to multiple receptors found in the brain"<ref name=":0" /> and that "These data indicate that montelukast is highest in brain regions known to be involved in (psychiatric effects)."<ref name=":0" /> The FDA does not plan to update the box warning label.<ref name=":0" />

==Drug interactions== Montelukast is an inhibitor of the drug metabolizing enzyme CYP2C8, part of the cytochrome P450 system. Therefore, it is theoretically possible that the combination of montelukast with a CYP2C8 substrate (e.g. amodiaquine, an anti-malarial drug) could increase the plasma concentrations of the substrate.<ref>{{Cite web|url=http://www.wipo.int/export/sites/www/research/en/data/sanofi/marketed_products/Artesunate_and_Amodiquine.pdf|title=Artesunate Amodiaquine Winthrop (artesunate, amodiaquine) {{!}} summary of product characteristics. Gentilly, France: Sanofi-aventis; August 2010.|access-date=24 October 2016|archive-date=24 October 2016|archive-url=https://web.archive.org/web/20161024090154/http://www.wipo.int/export/sites/www/research/en/data/sanofi/marketed_products/Artesunate_and_Amodiquine.pdf}}</ref><ref>{{cite journal | vauthors = German P, Greenhouse B, Coates C, Dorsey G, Rosenthal PJ, Charlebois E, Lindegardh N, Havlir D, Aweeka FT | title = Hepatotoxicity due to a drug interaction between amodiaquine plus artesunate and efavirenz | journal = Clinical Infectious Diseases | volume = 44 | issue = 6 | pages = 889–891 | date = March 2007 | pmid = 17304470 | doi = 10.1086/511882 | doi-access = free }}</ref> However, clinical studies have shown minimal interactions between montelukast and other CYP2C8 substrate drugs, which is most likely due to the high plasma protein binding exhibited by montelukast.<ref>{{cite journal | vauthors = Backman JT, Filppula AM, Niemi M, Neuvonen PJ | title = Role of Cytochrome P450 2C8 in Drug Metabolism and Interactions | journal = Pharmacological Reviews | volume = 68 | issue = 1 | pages = 168–241 | date = January 2016 | pmid = 26721703 | doi = 10.1124/pr.115.011411 | s2cid = 29099906 | doi-access = free }}</ref>

== Society and culture == === Patents === Singulair was covered by US Patent No. 5,565,473<ref>{{cite patent | country = US | number = 5565473 | url = https://patents.google.com/patent/US5565473A/en?oq=US5565473 | title = Unsaturated hydroxyalkylquinoline acids as leukotriene antagonists | inventor = Belley ML, Leger S, Labelle M, Roy P, Xiang YB, Guay D | assign1 = Merck Sharpe & Dohme | gdate = 15 October 1996 }} {{Webarchive|url=https://web.archive.org/web/20231123051902/https://patents.google.com/patent/US5565473A/en?oq=US5565473 |date=23 November 2023 }}</ref> which expired on 3 August 2012.<ref>{{Cite web|url=https://www.drugpatentwatch.com/p/patent/index.php?query=5,565,473|title=Drugs covered by patent 5,565,473. Claims, international patent equivalents, patent expiration dates, and freedom to operate|website=Deep knowledge on small-molecule drugs and the global patents covering them|access-date=27 January 2022|archive-date=27 January 2022|archive-url=https://web.archive.org/web/20220127122136/https://www.drugpatentwatch.com/p/patent/index.php?query=5,565,473|url-status=live}}</ref> The same day, the FDA approved several generic versions of montelukast.<ref>{{cite news|title=FDA approves first generic versions of Singulair to treat asthma, allergies|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm314436.htm|access-date=15 August 2012|date=3 August 2012|archive-date=6 August 2012|archive-url=https://web.archive.org/web/20120806202155/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm314436.htm|url-status=dead}}</ref>

The United States Patent and Trademark Office launched a reexamination of the patent covering Singulair in May 2009. The decision was driven by the discovery of references that were not included in the original patent application process. The references were submitted through Article One Partners, an online research community focused on finding literature relating to existing patents. The references included a scientific article produced by a Merck employee on the active ingredient in Singulair. A previously filed patent had been submitted in the same technology area.<ref>{{cite news |url=https://www.reuters.com/article/merck-singulair-idUSN2834535820090528 |title=U.S. Reexamines Merck's Singulair Patent |publisher=Thomson Reuters |date=28 May 2009 |access-date=6 July 2021 |archive-date=16 May 2021 |archive-url=https://web.archive.org/web/20210516135511/https://www.reuters.com/article/merck-singulair-idUSN2834535820090528 |url-status=live }}</ref> Seven months later the US Patent and Trademark Office determined that the patent in question was valid based on the initial reexamination and new information provided, submitting their decision on 17 December 2009.<ref>{{cite news |url=https://www.reuters.com/article/merck-singulair-idUSWEN770820091217 |title=Merck Says U.S. Agency Upholds Singulair Patent |publisher=Thomson Reuters |date=17 December 2009 |access-date=6 July 2021 |archive-date=18 May 2021 |archive-url=https://web.archive.org/web/20210518153835/https://www.reuters.com/article/merck-singulair-idUSWEN770820091217 |url-status=live }}</ref>

=== Use with loratadine ===

Schering-Plough and Merck sought permission to market a combined tablet with loratadine and montelukast. However, the FDA has found no benefit from a combined pill for seasonal allergies over taking the two drugs in combination,<ref>{{cite news | url=https://blogs.wsj.com/health/2008/04/28/fda-sneezes-at-claritin-singulair-combo-pill/?mod=WSJBlog | work=The Wall Street Journal | vauthors=Rubenstein S | title=FDA Sneezes at Claritin-Singulair Combo Pill | date=28 April 2008 | url-access=subscription | access-date=4 August 2017 | archive-date=25 March 2017 | archive-url=https://web.archive.org/web/20170325203522/http://blogs.wsj.com/health/2008/04/28/fda-sneezes-at-claritin-singulair-combo-pill/?mod=WSJBlog | url-status=live }}</ref> and in April 2008, issued a not-approvable letter for the combination.<ref>{{cite press release | title=Schering-Plough/Merck Pharmaceuticals Receives Not-Approvable Letter from FDA for Loratadine/Montelukast | website=Schering-Plough | date=25 April 2008 | url=http://www.schering-plough.com/schering_plough/news/release.jsp?releaseID=1135270 | archive-url=https://web.archive.org/web/20080924082232/http://www.schering-plough.com/schering_plough/news/release.jsp?releaseID=1135270 | archive-date=24 September 2008 | access-date=17 March 2020}}</ref>

=== Brand names === The ''Mont'' in montelukast stands for Montreal, where Merck (MSD) developed the drug.<ref>{{cite book | vauthors = Li JK |year=2006 |chapter=8 |title= Laughing Gas, Viagra, and Lipitor: The Human Stories Behind the Drugs We Use |chapter-url=https://books.google.com/books?id=vx5nDAAAQBAJ&q=montelukast+montreal&pg=PA234 |publisher= Oxford University Press |page= 234 |isbn=978-0-19-530099-4 |access-date=26 November 2017}}</ref>

Montelukast is sold under a variety of brand names including Monalast (Ziska Pharmaceuticals Ltd) Montenaaf (NAAFCO Pharma) Montelon-10 (Apex), Montene (Square), Montair-10, Lukotas,<ref>{{Cite web |title=Lukotas 10mg Tablet Price, Substitutes, Uses and Composition |url=https://www.rxjinn.com/prescription/Lukotas+10mg+Tablet/ |website=RxJinn }}</ref> Montelo-10, Monteflo, and Tukast L in India, Reversair (ACI Bangladesh), Monas, Miralust, Montiva, Provair, Montril, Lumona, Lumenta, Arokast and Trilock in Bangladesh, Ventair in Nepal, Montika in Pakistan, Montelair in Brazil, Zykast in the Philippines though combined with levocetirizine, Desmont, Levmont, Aircomb and Notta in Turkey, Topraz and Monte-Air in South Africa.<ref>{{cite web |title=Monte-Air |date=22 June 2022 |url=https://www.medicinesfaq.com/brand/monte-air |access-date=19 February 2024 }}</ref>

== References == {{reflist}}

{{Asthma and copd rx}} {{Leukotriene signaling modulators}} {{Merck&Co}} {{Portal bar | Medicine}} {{Authority control}}

Category:Alkene derivatives Category:Chloroarenes Category:Cyclopropanes Category:CYP2C8 inhibitors Category:Leukotriene antagonists Category:Drugs developed by Merck & Co. Category:Quinolines Category:Tertiary alcohols Category:Thioethers Category:Wikipedia medicine articles ready to translate Category:Meta-Phenylene compounds Category:Ortho-Phenylene compounds Category:Depressogens