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Generated: May 27, 2017

DrugPatentWatch Database Preview

Zafirlukast - Generic Drug Details

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

is the generic ingredient in two branded drugs marketed by Par Pharm Inc and Dr Reddys Labs Ltd, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for zafirlukast. Seven suppliers are listed for this compound.

Summary for Generic Name: zafirlukast

Drug Master File Entries: see list2
Suppliers / Packagers: see list7
Bulk Api Vendors: see list68
Clinical Trials: see list1
Patent Applications: see list5,389
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:zafirlukast at DailyMed

Pharmacology for Ingredient: zafirlukast

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd
TABLET;ORAL090372-001Nov 18, 2010ABRXNoNo► Subscribe► Subscribe
Par Pharm Inc
TABLET;ORAL020547-001Sep 26, 1996ABRXYesYes► Subscribe► Subscribe
Par Pharm Inc
TABLET;ORAL020547-003Sep 17, 1999ABRXYesNo► Subscribe► Subscribe
Dr Reddys Labs Ltd
TABLET;ORAL090372-002Nov 18, 2010ABRXNoNo► Subscribe► Subscribe
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