Viewing data from:

VIIBRYD

NDA

VILAZODONE HYDROCHLORIDE | N022567 | ABBVIE INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

25 trials from ClinicalTrials.gov, 22 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy Study of Vilazodone and Discovering Genetic Markers Associated With Response in Patients With Major Depressive Disorder NCT00290914	Phase 2	Completed	Pharmacology Research Institute	—	—
Vilazodone for Corticosteroid-Induced Memory Impairment NCT01828515	Phase 2	Completed	University of Texas Southwestern Medical Center	24	2012-12 → 2014-04
Study to Evaluate the Sexual Functioning of Healthy Adults After Receiving Vilazodone, Paroxetine or Placebo NCT02097147	Phase 1	Completed	Forest Laboratories	202	2014-03 → 2014-11
Double-Blind Treatment of Major Depressive Disorder With Vilazodone NCT01742832	Phase 2	Completed	University of Chicago	79	2013-05 → 2016-03
Vilazodone for Separation Anxiety Disorder NCT01999920	Phase 4	Completed	New York State Psychiatric Institute	24	2013-12 → 2017-12-30
Vilazodone Treatment for Marijuana Dependence NCT01574183	Phase 2	Completed	Medical University of South Carolina	76	2012-08 → 2016-02
Safety and Efficacy of Vilazodone in Major Depressive Disorder NCT01573598	Phase 4	Completed	Forest Laboratories	1,219	2012-04 → 2015-01
A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder NCT02436239	Phase 3	Completed	Forest Laboratories	330	2015-05-02 → 2018-07-23
Vilazodone for Menopausal Hot Flashes NCT01680900	N/A	Completed	University of Pennsylvania	36	2012-11 → 2013-08
Randomized, Double-Blind, Placebo Controlled Study of Vilazodone's Efficacy, Safety, and Biomarkers of Response in Major Depressive Disorder (MDD)NCT00683592	Phase 3	Completed	Forest Laboratories	481	2008-03 → 2009-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$12.21

per ea

Lowest NADAC/Unit

$12.14

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00456114030VIIBRYD 40 MG TABLET	$12.21	EA	Brand	$1.12	2026-06-17
00456111030VIIBRYD 10 MG TABLET	$12.14	EA	Brand	$0.9475	2026-06-17
00456112030VIIBRYD 20 MG TABLET	$12.14	EA	Brand	$0.8229	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 9 NDCs (6 FSS, 3 Big4)

Lowest Price

$76.92

Highest Price

$359.33

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00456-1120-30VIIBRYD 20MG TAB	$359.33	FSS	Abbvie US LLC	07/31/2030
00456-1120-30VIIBRYD 20MG TAB	$262.35	Big4	Abbvie US LLC	07/31/2030
00456-1140-30VIIBRYD 40MG TAB	$359.33	FSS	Abbvie US LLC	07/31/2030
00456-1140-30VIIBRYD 40MG TAB	$262.64	Big4	Abbvie US LLC	07/31/2030
42291-0949-30VILAZODONE HCL 20MG TAB	$77.74	FSS	AvKare, LLC	06/14/2028
42291-0948-30VILAZODONE HCL 10MG TAB	$76.92	FSS	AvKare, LLC	06/14/2028

Showing 6 of 9 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Viibryd (2024)

Total Spending

$6.0M

Total Claims

13,120

Beneficiaries

3,238

Avg Cost/Unit

$11.06

Spending Trend

$111.4M(2019)→$125.1M(2020)→$134.7M(2021)→$86.5M(2022)→$17.4M(2023)→$6.0M(2024)

YoY Change:-2.6%

5yr CAGR:+3.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain15 active DMFs

13 active API suppliers hold Drug Master Files for this ingredient.

MSN PHARMACHEM PRIVATE LTDVILAZODONE HYDROCHLORIDE [ROUTE CODE "VN"]

DMF 280722014

DR REDDYS LABORATORIES LTDVILAZODONE HYDROCHLORIDE

DMF 282602014

APOTEX INCVILAZODONE HYDROCHLORIDE BENZYL ALCOHOL MONOSOLVATE

DMF 283432014

MATRIX PHARMACORP PRIVATE LTDVILAZODONE HYDROCHLORIDE

DMF 283542014

ALIVUS LIFE SCIENCES LTDVILAZODONE HYDROCHLORIDE

DMF 283692014

MSN PHARMACHEM PRIVATE LTDVILAZODONE HYDROCHLORIDE [ROUTE CODE "VH"]

DMF 283882014

LUPIN LTDVILAZODONE HYDROCHLORIDE

DMF 284012014

ALEMBIC PHARMACEUTICALS LTDVILAZODONE HYDROCHLORIDE

DMF 284932014

ZYDUS LIFESCIENCES LTDVILAZODONE HYDROCHLORIDE

DMF 286562014

INTAS PHARMACEUTICALS LTDVILAZODONE HYDROCHLORIDE (AMORPHOUS)

DMF 287022014

TAPI NL BVVILAZODONE HYDROCHLORIDE

DMF 291962015

TIANJIN WEIJIE PHARMACEUTICAL CO LTDVILAZODONE HYDROCHLORIDE

DMF 311362016

JUBILANT BIOSYS LTDVILAZODONE HYDROCHLORIDE

DMF 336542019

ALEMBIC PHARMACEUTICALS LTDVILAZODONE HYDROCHLORIDE (FORM-IV)

DMF 344532020

VIYASH LIFE SCIENCES PRIVATE LTDVILAZODONE HYDROCHLORIDE

DMF 397182024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Apr 22, 2024	SUPPL -25	View Letter (PDF)
Aug 22, 2023	SUPPL -24	View Letter (PDF)
Sep 22, 2021	SUPPL -22	View Letter (PDF)
Feb 4, 2020	SUPPL -21	View Letter (PDF)
Jan 11, 2017	SUPPL -20	View Letter (PDF)
Sep 8, 2016	SUPPL -19	View Letter (PDF)
Apr 2, 2015	SUPPL -12	View Letter (PDF)
Jul 17, 2014	SUPPL -13	View Letter (PDF)
Apr 9, 2014	SUPPL -11	View Letter (PDF)
Dec 19, 2013	SUPPL -9	View Letter (PDF)
Dec 26, 2012	SUPPL -5	View Letter (PDF)
Sep 23, 2011	SUPPL -1	View Letter (PDF)
Jul 6, 2011	SUPPL -2	View Letter (PDF)
Jan 26, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 21, 2011

No patent or exclusivity listings for this strength.

#002 — 20MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 21, 2011

#003 — 40MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 21, 2011