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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 021400

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NDA 021400 describes LEVITRA, which is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the LEVITRA profile page.

The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.

Summary for 021400

Tradename:	LEVITRA
Applicant:	Bayer Hlthcare
Ingredient:	vardenafil hydrochloride
Patents:	1

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 19, 2003	TE:		RLD:	Yes
Patent:	8,273,876	Patent Expiration:	Jul 23, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 19, 2003	TE:		RLD:	Yes
Patent:	8,273,876	Patent Expiration:	Jul 23, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 19, 2003	TE:		RLD:	Yes
Patent:	8,273,876	Patent Expiration:	Jul 23, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET

Expired US Patents for NDA 021400

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-002	Aug 19, 2003	6,362,178	⤷ Get Started Free
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003	8,841,446	⤷ Get Started Free
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003	6,362,178	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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