Sildenafil Citrate

Treats erectile dysfunction. Sold as Viagra, Revatio, Vybrique, Liqrev. Every FDA application for this active ingredient: 6 branded and 52 generic.

As of Nov 15, 2026, FDA lists 58 applications for Sildenafil Citrate (sold as Viagra, Revatio, Vybrique and others), first approved Mar 27, 1998, with 11 new uses approved and 2 published complete response letters.

First approved: Mar 27, 1998
Applications: 58
New uses approved: 11
Complete response letters: 2
Medicare spending, 2025: $41.5M
Orphan exclusivity until: Jan 31, 2030
First approved in the EU: Sep 13, 1998

Medicare Spending

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


Sildenafil Citrate	Part D	$35.4M	-9%	223,532
Revatio	Part D	$6.1M	-16%	88
Viagra	Part D	$101K	-39%	56

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

SILDENAFIL 10 MG/ML ORAL SUSP: $0.234 per MLGeneric · -62% in a year
SILDENAFIL 100 MG TABLET: $0.137 per unitGeneric · -3% in a year
SILDENAFIL 20 MG TABLET: $0.052 per unitGeneric · -22% in a year
SILDENAFIL 25 MG TABLET: $0.122 per unitGeneric · +16% in a year
SILDENAFIL 50 MG TABLET: $0.111 per unitGeneric · -2% in a year
VIAGRA 100 MG TABLET: $83.70 per unitBrand · +0% in a year

Orphan Designations (FDA)

2 designations, 2 approved for the designated use; see all orphan designations

Treatment of pediatric (defined as children less than 17 years of age) pulmonary arterial hypertensionViatris Specialty LLC · designated Jul 28, 2011 · approved Mar 3, 2023
Treatment of pediatric (defined as children less than 17 years of age) pulmonary arterial hypertensionViatris Specialty LLC · designated Jul 28, 2011 · approved Jan 31, 2023 · exclusive to Jan 31, 2030

Approvals in the EU (EMA)

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

Granpidam, genericAccord Healthcare S.L.U. · Nov 14, 2016
Mysildecard, genericViatris Limited · Sep 15, 2016
Sildenafil ratiopharm, genericRatiopharm GmbH · Dec 23, 2009
Sildenafil Actavis, genericActavis Group PTC ehf · Dec 10, 2009
Sildenafil Teva, genericTeva B.V. · Nov 30, 2009
Vizarsin, genericKRKA tovarna zdravil d.d. Novo mesto · Sep 21, 2009
RevatioViatris EESV · Oct 28, 2005
PatrexPfizer Limited · Sep 15, 1998 · withdrawn

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

RevatioDrugs with a new additional pediatric dosage and in additional dosage forms indicated for the treatment of pulmonary arterial hypertension. · Pfizer Japan Inc. · Sep 27, 2017

Clinical Trials

42 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


The Effect of Additive On-Demand Sildenafil vs. Dextrose Candy on Maximum Exercise Capacity in Pulmonary Arterial HypertensionPulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) · Silvia Ulrich	Phase 2 / Phase 3	Recruiting	Sep 17, 2026
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Viaca (Sildenafil + Cabergoline) Compared With Sildenafil and CabergolineErectile Dysfunctions, Healthy Volunteer · Yanping Kong	Phase 1	Not yet recruiting	Jul 28, 2026
Randomized Study of Triple Therapy vs Sildenafil Dose Optimization in Pulmonary Arterial HypertensionPulmonary Arterial Hypertension (PAH) · University of Sao Paulo General Hospital	Phase 4	Recruiting	Jul 20, 2026
A Study to Evaluate the Effect of Two Fixed-Dose Leucine, Sildenafil and Metformin Combinations on Blood Pressure in Individuals With HypertensionHypertension · NuSirt Biopharma	Phase 2	Not yet recruiting	Jun 15, 2026
A Single-Arm, Dose Escalation of an Intraurethral Alprostadil Paste for Erectile DysfunctionErectile Dysfunction (ED), Erectile Dysfunctions · Ryan Flannigan, MD	Phase 2	Recruiting	May 22, 2026
Effect of Sildenafil on Left Ventricular Function in Pediatric With Primary Dilated CardiomyopathyCardiomyopathy, Dilated · Assiut University	—	Not yet recruiting	Apr 17, 2026
Vaginal Sildenafil for Primary DysmenorrheaDysmenorrhea, Menstrual Pain · Kevin Hellman	Phase 1	Not yet recruiting	Apr 2, 2026
Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder PatientsErectile Dysfunctions · Mansoura University	Phase 4	Recruiting	Feb 6, 2026

Applications

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


Mar 27, 1998	ViagraNDA 20895 · New molecular entity	Viatris	34	Marketed
Jun 3, 2005	RevatioNDA 21845 · New formulation or manufacturer	Viatris	18	Marketed
Nov 18, 2009	RevatioNDA 22473 · New dosage form	Viatris	12	Marketed
Aug 30, 2012	RevatioNDA 203109 · New dosage form	Viatris	13	Discontinued
Nov 6, 2012	Sildenafil CitrateANDA 91379	Apotex Corp	2	Discontinued
Nov 6, 2012	Sildenafil CitrateANDA 91479	Torrent Pharms Ltd	5	Marketed
Nov 6, 2012	Sildenafil CitrateANDA 202598	Chartwell Rx	3	Marketed
Nov 6, 2012	Sildenafil CitrateANDA 202503	Watson Labs Inc	3	Marketed
Nov 9, 2012	Sildenafil CitrateANDA 201150	Mylan Pharms Inc	5	Discontinued
Jan 7, 2013	Sildenafil CitrateANDA 78380	Teva Pharms	5	Discontinued
Feb 25, 2013	Sildenafil CitrateANDA 200149	Actavis Grp Ptc	0	Discontinued
Feb 28, 2013	Sildenafil CitrateANDA 202025	Amneal Pharms	4	Marketed
Dec 17, 2013	Sildenafil CitrateANDA 203814	Macleods Pharms	8	Marketed
Nov 26, 2014	Sildenafil CitrateANDA 203623	Hetero Labs Ltd V	4	Marketed
Apr 1, 2015	Sildenafil CitrateANDA 203988	Eugia Pharma	2	Marketed
Nov 18, 2015	Sildenafil CitrateANDA 203963	Aurobindo Pharma Ltd	4	Marketed
Mar 9, 2016	Sildenafil CitrateANDA 77342	Teva	3	Marketed
Jun 20, 2016	Sildenafil CitrateANDA 204883	Rubicon Research	4	Marketed
May 4, 2018	Sildenafil CitrateANDA 210394	Ajanta Pharma Ltd	2	Marketed
Jun 11, 2018	Sildenafil CitrateANDA 91448	Torrent	0	Marketed
Jun 11, 2018	Sildenafil CitrateANDA 202659	Hetero Labs Ltd V	0	Marketed
Jun 11, 2018	Sildenafil CitrateANDA 203962	Aurobindo Pharma Ltd	0	Marketed
Jun 11, 2018	Sildenafil CitrateANDA 204882	Rubicon Research	0	Marketed
Jun 27, 2018	Sildenafil CitrateANDA 202023	Amneal Pharms Ny	0	Marketed
Oct 12, 2018	Sildenafil CitrateANDA 206401	Ajanta Pharma Ltd	0	Marketed
Mar 22, 2019	Sildenafil CitrateANDA 212051	Chartwell Rx	0	Marketed
Mar 25, 2019	Sildenafil CitrateANDA 201171	Mylan	0	Discontinued
May 31, 2019	Sildenafil CitrateANDA 212260	Novitium Pharma	2	Marketed
Nov 27, 2019	Sildenafil CitrateANDA 211092	Amneal Pharms	1	Marketed
Nov 27, 2019	Sildenafil CitrateANDA 212440	Alkem Labs Ltd	1	Marketed
Nov 27, 2019	Sildenafil CitrateANDA 212883	Ajanta Pharma Ltd	2	Marketed
Mar 2, 2020	Sildenafil CitrateANDA 207178	Appco	0	Marketed
Apr 23, 2020	Sildenafil CitrateANDA 205791	Perrigo R And D	0	Discontinued
May 29, 2020	Sildenafil CitrateANDA 211534	Teva Pharms USA	0	Marketed
Jun 11, 2020	Sildenafil CitrateANDA 213032	Sunshine	0	Marketed
Jun 12, 2020	Sildenafil CitrateANDA 208494	Reyoung	0	Marketed
Aug 6, 2020	Sildenafil CitrateANDA 213041	Invagen Pharms	1	Marketed
Aug 25, 2020	Sildenafil CitrateANDA 209302	Umedica	1	Marketed
Nov 25, 2020	Sildenafil CitrateANDA 202506	Watson Labs Inc	0	Discontinued
Apr 29, 2021	Sildenafil CitrateANDA 213814	Chartwell Rx	0	Marketed
May 11, 2021	Sildenafil CitrateANDA 213014	Hetero Labs Ltd V	0	Marketed
Nov 16, 2021	Sildenafil CitrateANDA 215522	Taro	0	Discontinued
Nov 17, 2021	Sildenafil CitrateANDA 212312	Tris Pharma Inc	0	Discontinued
Feb 8, 2022	Sildenafil CitrateANDA 214641	Msn	0	Marketed
Mar 23, 2022	Sildenafil CitrateANDA 211638	Lupin	0	Discontinued
Sep 29, 2022	Sildenafil CitrateANDA 215708	Zydus Lifesciences	0	Marketed
Dec 23, 2022	Sildenafil CitrateANDA 214773	Aurobindo Pharma Ltd	0	Marketed
Apr 19, 2023	Sildenafil CitrateANDA 202255	Macleods Pharms	0	Marketed
Apr 28, 2023	LiqrevNDA 214952 · New formulation or manufacturer	Cmp Dev LLC	0	Discontinued
Aug 29, 2023	Sildenafil CitrateANDA 216383	Novitium Pharma	0	Marketed
Nov 28, 2023	Sildenafil CitrateANDA 218045	Cadila Pharms Ltd	0	Marketed
Dec 1, 2023	Sildenafil CitrateANDA 214556	Granules	0	Discontinued
Dec 20, 2024	Sildenafil CitrateANDA 201156	Jubilant Generics	0	Marketed
Mar 6, 2025	Sildenafil CitrateANDA 202954	Jubilant Generics	0	Marketed
Dec 16, 2025	VybriqueNDA 210858 · New dosage form	Ibsa	0	Marketed
—	Sildenafil CitrateANDA 91378	Apotex Corp	0	Discontinued
—	Sildenafil CitrateANDA 200165	Actavis Pharma	0	Discontinued
—	Sildenafil CitrateANDA 202597	Dr Reddys Labs Ltd	0	Discontinued

Show all 58

Complete Response Letters

FDA's published letters for these applications


Apr 28, 2022	SildenafilFacility Inspections	Approved
Aug 5, 2021	LIQREV (sildenafil)Product Quality	Approved

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