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

2 trials from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression NCT06591091	Phase 2	Recruiting	University of Illinois at Chicago	80	2025-12-10 → 2026-12
Department of Defense PTSD Adaptive Platform Trial - Master Protocol NCT05422612	Phase 2	Suspended	Global Coalition for Adaptive Research	800	2023-11-02 → 2029-07

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

Medicare Part D Spending

CMS annual spending data for Viibryd (2023)

Total Spending

$17.4M

Total Claims

40,574

Beneficiaries

8,233

Avg Cost/Unit

$11.36

Spending Trend

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

YoY Change:+5.3%

5yr CAGR:+5.4%

Source: CMS Medicare Part D Spending by Drug (2023). 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 PHARMOVA 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