Vardenafil Hydrochloride

Sold as Levitra, Staxyn. Every FDA application for this active ingredient: 2 branded and 10 generic.

As of Nov 15, 2026, FDA lists 12 applications for Vardenafil Hydrochloride (sold as Levitra, Staxyn), first approved Aug 19, 2003, with 3 new uses approved and 0 published complete response letters.

First approved: Aug 19, 2003
Applications: 12
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $260K
First approved in the EU: Mar 4, 2003

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Vardenafil HCl	Part D	$260K	-50%	693

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

VARDENAFIL HCL 10 MG ODT: $21.76 per unitGeneric · +11% in a year
VARDENAFIL HCL 10 MG TABLET: $4.13 per unitGeneric · +39% in a year
VARDENAFIL HCL 20 MG TABLET: $2.63 per unitGeneric · +13% in a year
VARDENAFIL HCL 5 MG TABLET: $7.10 per unitGeneric · +43% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of Pulmonary Arterial HypertensionRespira Therapeutics, Inc · designated Apr 22, 2019

Approvals in the EU (EMA)

First approved in the EU 6 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

LevitraBayer AG · Mar 6, 2003
Vivanza, new substanceBayer AG · Mar 4, 2003 · withdrawn

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Aug 19, 2003	LevitraNDA 21400 · New molecular entity	Bayer Hlthcare	13	Discontinued
Jun 17, 2010	StaxynNDA 200179 · New dosage form	Bayer Hlthcare	6	Discontinued
May 3, 2012	Vardenafil HydrochlorideANDA 91347	Teva Pharms	4	Marketed
Oct 31, 2018	Vardenafil HydrochlorideANDA 208960	Zydus Pharms	0	Marketed
Oct 31, 2018	Vardenafil HydrochlorideANDA 209057	Crossmedika SA	1	Marketed
Oct 31, 2018	Vardenafil HydrochlorideANDA 210738	Stevens J	1	Discontinued
Nov 16, 2018	Vardenafil HydrochlorideANDA 208324	Alembic	0	Marketed
Oct 22, 2019	Vardenafil HydrochlorideANDA 204632	Macleods Pharms	1	Marketed
Mar 10, 2020	Vardenafil HydrochlorideANDA 205988	Macleods Pharms	1	Marketed
Aug 4, 2020	Vardenafil HydrochlorideANDA 214031	Alembic	1	Marketed
—	Vardenafil HydrochlorideANDA 203689	Watson Labs Teva	0	Discontinued
—	Vardenafil HydrochlorideANDA 204786	Par Pharm Inc	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA