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Last Updated: March 28, 2024

ACCOLATE Drug Patent Profile


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Which patents cover Accolate, and what generic alternatives are available?

Accolate is a drug marketed by Strides Pharma and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Accolate

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

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Drug patent expirations by year for ACCOLATE
Drug Prices for ACCOLATE

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Recent Clinical Trials for ACCOLATE

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

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

See all ACCOLATE clinical trials

Paragraph IV (Patent) Challenges for ACCOLATE
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 ACCOLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Strides Pharma ACCOLATE zafirlukast TABLET;ORAL 020547-003 Sep 17, 1999 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma ACCOLATE zafirlukast TABLET;ORAL 020547-001 Sep 26, 1996 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ACCOLATE

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

International Patents for ACCOLATE

See the table below for patents covering ACCOLATE around the world.

Country Patent Number Title Estimated Expiration
African Regional IP Organization (ARIPO) 286 Physical form of an indolyl sulphonamide, processes for preparing it and pharmaceutical compositions containing it. ⤷  Try a Trial
Spain 2032384 ⤷  Try a Trial
New Zealand 240939 A PHYSICAL FORM OF N-[4-[5-(CYCLOPENTYLOXYCARBONYL)-AMINO-1-METHYLINDOL-3-YL- METHYL]-3-METHOXYBENZOYL]-2-METHYL-BENZENESULPHONAMIDE WITH PARTICULAR IR SPECTRUM ⤷  Try a Trial
Norway 864130 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ACCOLATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0199543 97C0031 Belgium ⤷  Try a Trial PRODUCT NAME: ZAFIRLUKAST; NAT. REGISTRATION NO/DATE: 624 S 295 F 3 19961216; FIRST REGISTRATION: IE PA 51/67/1 19960103
0199543 SPC/GB98/033 United Kingdom ⤷  Try a Trial PRODUCT NAME: ZAFIRLUKAST AND OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT.; REGISTERED: IE PA 51/67/1 19960103; UK 12619/0108 19980605
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.