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Last Updated: April 19, 2024

Montelukast sodium - Generic Drug Details

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What are the generic drug sources for montelukast sodium and what is the scope of freedom to operate?

Montelukast sodium is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Teva Pharms, Torrent, Organon, Amneal Pharms, Anbison Lab, Apotex Inc, Chartwell Molecular, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Rising, Sandoz Inc, Strides Pharma, Torrent Pharms Ltd, Unichem, Unimark Remedies Ltd, Accord Hlthcare, Apotex Corp, Breckenridge, Cipla, Glenmark Generics, Graviti Pharms, and L Perrigo Co, and is included in fifty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-three drug master file entries for montelukast sodium. Forty-one suppliers are listed for this compound.

Summary for montelukast sodium

US Patents:	0
Tradenames:	2
Applicants:	29
NDAs:	52
Drug Master File Entries:	33
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	81
Patent Applications:	6,516
Formulation / Manufacturing:	see details
Drug Sales Revenues:	Drug sales revenues for montelukast sodium
What excipients (inactive ingredients) are in montelukast sodium?	montelukast sodium excipients list
DailyMed Link:	montelukast sodium at DailyMed

Drug Sales Revenue Trends for montelukast sodium

See drug sales revenues for montelukast sodium

Recent Clinical Trials for montelukast sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mansoura University Children Hospital	Phase 1
Zhejiang Provincial Hospital of TCM	Phase 4
First People's Hospital Affiliated to Huzhou University	Phase 4

See all montelukast sodium clinical trials

Pharmacology for montelukast sodium

Drug Class	Leukotriene Receptor Antagonist
Mechanism of Action	Leukotriene Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for montelukast sodium

R03DC	Leukotriene receptor antagonists
R03D	OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for MONTELUKAST SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SINGULAIR	Oral Granules	montelukast sodium	4 mg	021409	1	2008-10-17
SINGULAIR	Tablets	montelukast sodium	10 mg	020829	2	2007-02-20
SINGULAIR	Chewable Tablets	montelukast sodium	4 mg and 5 mg	020830	1	2006-12-26

US Patents and Regulatory Information for montelukast sodium

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	205107-002	Sep 4, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cipla	MONTELUKAST SODIUM	montelukast sodium	TABLET;ORAL	207463-001	Oct 28, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Strides Pharma	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	091588-001	Aug 3, 2012		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hetero Labs Ltd V	MONTELUKAST SODIUM	montelukast sodium	TABLET;ORAL	202843-001	Sep 10, 2014	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Macleods Pharms Ltd	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	203582-001	Mar 12, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for montelukast sodium

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-002	Mar 3, 2000	⤷ Try a Trial	⤷ Try a Trial
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-001	Feb 20, 1998	⤷ Try a Trial	⤷ Try a Trial
Organon	SINGULAIR	montelukast sodium	TABLET;ORAL	020829-002	Feb 20, 1998	⤷ Try a Trial	⤷ Try a Trial
Organon	SINGULAIR	montelukast sodium	GRANULE;ORAL	021409-001	Jul 26, 2002	⤷ Try a Trial	⤷ Try a Trial
Organon	SINGULAIR	montelukast sodium	GRANULE;ORAL	021409-001	Jul 26, 2002	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.