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Last Updated: September 23, 2020

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When do Zafirlukast patents expire, and what generic alternatives are available?

Zafirlukast is a drug marketed by Dr Reddys Labs Ltd and is included in one NDA.

The generic ingredient in ZAFIRLUKAST is zafirlukast. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the zafirlukast profile page.

US ANDA Litigation and Generic Entry Outlook for Zafirlukast

A generic version of ZAFIRLUKAST was approved as zafirlukast by DR REDDYS LABS LTD on November 18th, 2010.

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Drug patent expirations by year for ZAFIRLUKAST
Drug Prices for ZAFIRLUKAST

See drug prices for ZAFIRLUKAST

Recent Clinical Trials for ZAFIRLUKAST

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

National Institutes of Health (NIH)Phase 2
Dana-Farber Cancer InstitutePhase 2
University of California, San FranciscoPhase 2

See all ZAFIRLUKAST clinical trials

Paragraph IV (Patent) Challenges for ZAFIRLUKAST
Tradename Dosage Ingredient NDA Submissiondate
ACCOLATE TABLET;ORAL zafirlukast 020547 2008-02-29

US Patents and Regulatory Information for 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 ZAFIRLUKAST zafirlukast TABLET;ORAL 090372-001 Nov 18, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd ZAFIRLUKAST zafirlukast TABLET;ORAL 090372-002 Nov 18, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Johnson and Johnson

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