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Last Updated: March 29, 2024

FLEQSUVY Drug Patent Profile


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Which patents cover Fleqsuvy, and when can generic versions of Fleqsuvy launch?

Fleqsuvy is a drug marketed by Azurity and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has four patent family members in four countries.

The generic ingredient in FLEQSUVY is baclofen. There are twenty-one drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the baclofen profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fleqsuvy

A generic version of FLEQSUVY was approved as baclofen by IVAX SUB TEVA PHARMS on July 21st, 1988.

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Paragraph IV (Patent) Challenges for FLEQSUVY
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FLEQSUVY Oral Suspension baclofen 25 mg/5 mL 215602 1 2022-05-20

US Patents and Regulatory Information for FLEQSUVY

FLEQSUVY is protected by two US patents.

Patents protecting FLEQSUVY

Suspensions and diluents for metronidazole and baclofen
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: INDICATED FOR THE TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Azurity FLEQSUVY baclofen SUSPENSION;ORAL 215602-001 Feb 4, 2022 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Azurity FLEQSUVY baclofen SUSPENSION;ORAL 215602-001 Feb 4, 2022 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

International Patents for FLEQSUVY

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

Country Patent Number Title Estimated Expiration
Canada 3036356 SUSPENSIONS ET DILUANTS POUR LE METRONIDAZOLE ET LE BACLOFENE (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2018049184 ⤷  Try a Trial
European Patent Office 3509592 SUSPENSIONS ET DILUANTS POUR LE MÉTRONIDAZOLE ET LE BACLOFÈNE (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN) ⤷  Try a Trial
China 109922801 甲硝唑和巴氯芬的混悬剂和稀释剂 (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.