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Generated: April 30, 2017

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Montelukast sodium - Generic Drug Details

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

Montelukast sodium
is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc, Amneal Pharms, Kremers Urban Pharms, Teva Pharms, Dr Reddys Labs Ltd, Apotex Inc, Merck, Sandoz Inc, Torrent Pharms Ltd, Accord Hlthcare, Glenmark Generics, Ajanta Pharma Ltd, West-ward Pharms Int, Unimark Remedies Ltd, Hetero Labs Ltd V, Cipla Ltd, Macleods Pharms Ltd, Aurobindo Pharma Ltd, Vintage Pharms Llc, Anbison Lab Co Ltd, Unichem Labs Ltd, Apotex Corp, and Jubilant Generics, and is included in forty-three NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Montelukast sodium has twenty-five patent family members in twenty-five countries.

There are thirty-two drug master file entries for montelukast sodium. Fifty-eight suppliers are listed for this compound.

Summary for Generic Name: montelukast sodium

Drug Master File Entries: see list32
Suppliers / Packagers: see list58
Bulk Api Vendors: see list43
Clinical Trials: see list998
Patent Applications: see list3,109
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:montelukast sodium at DailyMed

Pharmacology for Ingredient: montelukast sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Unichem Labs Ltd
montelukast sodium
TABLET;ORAL204290-001Oct 8, 2015ABRXNoNo► Subscribe► Subscribe
Jubilant Generics
montelukast sodium
TABLET, CHEWABLE;ORAL203795-001Feb 27, 2015ABRXNoNo► Subscribe► Subscribe
montelukast sodium
TABLET, CHEWABLE;ORAL020830-002Mar 3, 2000ABRXYesNo► Subscribe► Subscribe
montelukast sodium
TABLET;ORAL020829-002Feb 20, 1998ABRXYesYes► Subscribe► Subscribe
Apotex Inc
montelukast sodium
TABLET, CHEWABLE;ORAL201508-002Aug 3, 2012ABRXNoNo► Subscribe► Subscribe
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