ZAFIRLUKAST - Generic Drug Details

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

Zafirlukast is the generic ingredient in two branded drugs marketed by Strides Pharma, Annora Pharma, Aurobindo Pharma, Dr Reddys Labs Ltd, and Rising Pharms, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for ZAFIRLUKAST

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	7
Patent Applications:	6,798
Drug Prices:	Drug price trends for ZAFIRLUKAST
What excipients (inactive ingredients) are in ZAFIRLUKAST?	ZAFIRLUKAST excipients list
DailyMed Link:	ZAFIRLUKAST at DailyMed

See drug prices for ZAFIRLUKAST

Recent Clinical Trials for ZAFIRLUKAST

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

Sponsor	Phase
Allergy & Asthma Medical Group & Research Center	Phase 2
King Abdullah International Medical Research Center	Phase 3
National Institutes of Health (NIH)	Phase 2

See all ZAFIRLUKAST clinical trials

Pharmacology for ZAFIRLUKAST

Drug Class	Leukotriene Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C9 Inhibitors Leukotriene Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ZAFIRLUKAST

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 ZAFIRLUKAST

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACCOLATE	Tablets	zafirlukast	10 mg and 20 mg	020547	1	2008-02-29

US Patents and Regulatory Information for ZAFIRLUKAST

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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
Dr Reddys Labs Ltd	ZAFIRLUKAST	zafirlukast	TABLET;ORAL	090372-001	Nov 18, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	ZAFIRLUKAST	zafirlukast	TABLET;ORAL	213163-001	Nov 27, 2023	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 ZAFIRLUKAST

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	⤷ Sign Up	⤷ Sign Up
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	⤷ Sign Up	⤷ Sign Up
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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