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, Norvium Bioscience, 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, Natco Pharma, Rising, Sandoz Inc, Strides Pharma, Torrent Pharms Ltd, Unichem, Unimark Remedies Ltd, Accord Hlthcare, Apotex Corp, Breckenridge, Cipla, Glenmark Pharms Ltd, 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:	6,261
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
Zibo Central Hospital	Phase 4
The Children's Hospital of Zhejiang University School of Medicine	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	205107-001	Sep 4, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Torrent Pharms Ltd	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	090984-002	Aug 3, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Torrent Pharms Ltd	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	090984-001	Aug 3, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex Corp	MONTELUKAST SODIUM	montelukast sodium	TABLET;ORAL	201294-001	Aug 3, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ajanta Pharma Ltd	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	203328-002	Jul 31, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-002	Mar 3, 2000	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	MONTELUKAST SODIUM	montelukast sodium	TABLET;ORAL	209012-001	Apr 24, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	GRANULE;ORAL	021409-001	Jul 26, 2002	⤷ Sign Up	⤷ Sign Up
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-001	Feb 20, 1998	⤷ Sign Up	⤷ Sign Up
Organon	SINGULAIR	montelukast sodium	TABLET;ORAL	020829-002	Feb 20, 1998	⤷ Sign Up	⤷ Sign Up
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-002	Mar 3, 2000	⤷ Sign Up	⤷ Sign Up
Organon	SINGULAIR	montelukast sodium	GRANULE;ORAL	021409-001	Jul 26, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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