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VENLAFAXINE BESYLATE

NDA

VENLAFAXINE BESYLATE | N215429 | ALMATICA PHARMA LLC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

Today

7776358

May. 16, 2028

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

153 trials from ClinicalTrials.gov, 124 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR in Healthy Subjects NCT00329186	Phase 3	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	14	2006-05 → 2007-06
Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy NCT03574792	Phase 2	Completed	Roswell Park Cancer Institute	62	2018-05-03 → 2021-11-11
A Multi-level Life-span Characterization of Adult-depression and Effects of Medication and Exercise NCT02407704	Phase 4	Completed	Kirk Erickson, PhD	31	2015-03 → 2016-12
A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression NCT02417064	Phase 3	Completed	Janssen Research & Development, LLC	346	2015-08-10 → 2018-02-20
Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?NCT00186264	N/A	Completed	Stanford University	18	2002-08 → 2006-04
Prolonging Remission in Depressed Elderly (PRIDE)NCT01028508	Phase 4	Completed	Icahn School of Medicine at Mount Sinai	247	2010-01 → 2016-03
Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression NCT00714090	Phase 3	Completed	Club rTMS et Psychiatrie	170	2008-05 → 2013-07
Treatment of Adolescent Suicide Attempters (TASA)NCT00080158	Phase 2/3	Completed	New York State Psychiatric Institute	120	2004-03 → 2007-06
Study of Antidepressants in Parkinson's Disease NCT00086190	Phase 3	Completed	University of Rochester	115	2005-06 → 2009-11
Serotonin Effect in Functional Dyspepsia NCT00115362	N/A	Completed	Radboud University Medical Center	300	2005-07 → 2007-07

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$6.18

per ea

Lowest NADAC/Unit

$6.18

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
52427063230VENLAFAXINE BES ER 112.5 MG TB	$6.18	EA	Generic	—	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$145.21

Highest Price

$185.47

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
52427-0632-30VENLAFAXINE BES ER 112.5 MG TB	$185.47	FSS	Almatica LLC.	07/14/2030
52427-0632-30VENLAFAXINE BES ER 112.5 MG TB	$145.21	Big4	Almatica LLC.	07/14/2030

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

Medicare Part D Spending

CMS annual spending data for Venlafaxine Besylate ER (2024)

Total Spending

$759K

Total Claims

2,648

Beneficiaries

745

Avg Cost/Unit

$6.45

Spending Trend

$40K(2022)→$434K(2023)→$759K(2024)

YoY Change:-4.1%

5yr CAGR:-0.4%

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Aug 22, 2023	SUPPL -1	View Letter (PDF)
Jun 30, 2022	ORIG -1	View Letter (PDF)
Jun 30, 2022	ORIG -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 112.5MG BASE

RLD

1 patent0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 29, 2022

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7776358	May 16, 2028	—	—	Yes	—	—