FLEQSUVY Drug Patent Profile

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

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-five 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 21^st, 1988.

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Summary for FLEQSUVY

International Patents:	4
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	150
Patent Applications:	3,917
Drug Prices:	Drug price information for FLEQSUVY
What excipients (inactive ingredients) are in FLEQSUVY?	FLEQSUVY excipients list
DailyMed Link:	FLEQSUVY at DailyMed

Drug patent expirations by year for FLEQSUVY

Pharmacology for FLEQSUVY

Drug Class	gamma-Aminobutyric Acid-ergic Agonist
Mechanism of Action	GABA A Agonists GABA B Agonists

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: INDICATED FOR THE TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS

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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
Azurity	FLEQSUVY	baclofen	SUSPENSION;ORAL	215602-001	Feb 4, 2022	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Azurity	FLEQSUVY	baclofen	SUSPENSION;ORAL	215602-001	Feb 4, 2022	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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.

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