CLINICAL TRIALS PROFILE FOR VENLAFAXINE HYDROCHLORIDE

505(b)(2) Clinical Trials for VENLAFAXINE HYDROCHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT05875610 ↗	Preventive Approach Using Venlafaxine	Recruiting	Mit Ghamr Oncology Center	Phase 4	2023-05-01	Peripheral and Motor neuropathy represent a main obstacle for a better quality of life for cancer patients, Venlafaxine is introduced in a new dosing regimen for treating of oxaliplatin and taxanes induced peripheral neuropathy in cancer patients.

All Clinical Trials for VENLAFAXINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001483 ↗	Acute Effectiveness of Additional Drugs to the Standard Treatment of Depression	Completed	National Institute of Mental Health (NIMH)	Phase 2	1995-06-01	This study will compare the effectiveness of relatively new antidepressants which have different mechanisms of action. Buproprion (Wellbutrin) works on dopamine and the dopaminergic pathway. Sertraline (Zoloft) works as a selective serotonin reuptake inhibitor (SSRI). Venlafaxine (Effexor) works as a mixed serotonin, norepinephrine, and dopamine reuptake inhibitor. Subjects enrolled in this study will be patients diagnosed with a bipolar disorder who are presently taking medication to prevent the symptoms of the disease (prophylactic treatment), but have had breakthrough episodes of depression despite taking their medication. Patients will receive any one of the three antidepressant medications as noted above plus a placebo inactive sugar pill, in order to mask which antidepressant is being prescribed) in addition to their regular medication for bipolar disorder. All of the doses will be calculated as effective for the treatment of a unipolar major depressive disorder. The patient will continue receiving the medication for ten weeks. The effectiveness of the drug treatment will be measured by using three different scales; 1. Inventory for Depressive Symptoms - Clinicians form (IDS-C) 2. Clinical Global Impression scale(CGI-BP) 3. Life Charting Methodology (LCM) Patients who do not respond to their medication within ten weeks from the beginning of the study will be considered as non-responders and be offered the opportunity to start the study again, taking one of the two remaining medications. For example, if a patient was assigned to take Wellbutrin but it was ineffective, he/she could re-enter the study and be given either Zoloft or Effexor. Patients that do respond in the first ten weeks of the study will be eligible to continue taking the medication for one year to assess the long term effectiveness of the drug on preventing episodes of depression and to assess for any possible differential induction of mania.
NCT00018902 ↗	Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)	Completed	National Institute of Mental Health (NIMH)	Phase 2/Phase 3	2001-01-01	The purpose of the study is to determine how best to treat adolescents with depression that is "resistant" to the first SSRI antidepressant they have tried. Participants receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy.
NCT00018902 ↗	Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)	Completed	University of Pittsburgh	Phase 2/Phase 3	2001-01-01	The purpose of the study is to determine how best to treat adolescents with depression that is "resistant" to the first SSRI antidepressant they have tried. Participants receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy.
NCT00026052 ↗	Riluzole to Treat Major Depression	Completed	National Institute of Mental Health (NIMH)	Phase 2	2001-11-01	This study will examine the safety and effectiveness of the drug riluzole (Rilutek® (Registered Trademark)) for short-term treatment of depression symptoms, such as depressed mood, psychomotor retardation, and excessive sleeping. Despite the availability of a wide range of antidepressant drugs, studies indicate that 30 to 40 percent of patients with major depression do not respond to first-line antidepressant treatment with drugs such as fluoxetine, upropion, venlafaxine and others. Riluzole, which is approved by the Food and Drug Administration (FDA) for amyotrophic lateral sclerosis (ALS), causes chemical changes in the brain that may also have antidepressant properties. Patients between 18 and 70 years of age with major depressive disorder without psychotic features may be eligible for this 2-stage 7-week study. Candidates will be screened with a medical history and physical examination, including an electrocardiogram (EKG), blood and urine tests, and a psychiatric evaluation. A blood or urine sample will be tested for illegal drugs.Women of childbearing potential will have a pregnancy test. Participants will complete stage 1 of the study, which lasts 1 week, and may then continue with stage 2 for an additional 6 weeks. At the start of the study, patients will be tapered off all psychiatric medicines and will begin treatment with a placebo (a sugar pill formulated to look like the active drug). At some point, they will be switched from placebo to riluzole. In addition, participants will undergo the following procedures: - Physical examination and electrocardiograms (EKG) at the beginning and end of the study, with vital signs (temperature, blood pressure and heart rate) checked daily - Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to assess treatment response - Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects At the end of the study, participants' psychiatric status will be reassessed and appropriate long-term psychiatric treatment arranged. Patients, ages 18 to 70 with a diagnosis of major depression without psychotic features, will in this pilot study (single arm, single blind) receive riluzole (50-200 mg/day) for a period of 6 weeks. Acute efficacy will be determined by demonstrating a greater response rate using specified criteria. Approximately 25 patients will enter the study to obtain 22 subjects who complete the 6 weeks of acute riluzole treatment. Therefore, if 7/22 patients or greater have greater than 50% improvement on the primary efficacy measure, then based on statistically guidelines from the Optimal Two Stage Design for Clinical Trials, a controlled trial would be indicated to scientifically confirm the signal observed in the single arm trial.
NCT00030914 ↗	Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women	Completed	National Cancer Institute (NCI)	Phase 3	2002-04-01	RATIONALE: Medroxyprogesterone and venlafaxine may be effective in relieving hot flashes. It is not yet known whether venlafaxine is more effective than medroxyprogesterone in relieving hot flashes. PURPOSE: Randomized phase III trial to compare the effectiveness of medroxyprogesterone with that of venlafaxine in treating women who are experiencing hot flashes.
NCT00030914 ↗	Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women	Completed	Alliance for Clinical Trials in Oncology	Phase 3	2002-04-01	RATIONALE: Medroxyprogesterone and venlafaxine may be effective in relieving hot flashes. It is not yet known whether venlafaxine is more effective than medroxyprogesterone in relieving hot flashes. PURPOSE: Randomized phase III trial to compare the effectiveness of medroxyprogesterone with that of venlafaxine in treating women who are experiencing hot flashes.
NCT00038896 ↗	Study Evaluating Venlafaxine ER in Adults With Panic Disorder	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2001-04-01	The primary objective of this study is to determine the efficacy, safety, and tolerability of a flexible dose of venlafaxine extended-release (ER) capsules administered for 10 weeks in the treatment of adult outpatients with panic disorder (PD) in a placebo-controlled phase III study.

Clinical Trial Conditions for VENLAFAXINE HYDROCHLORIDE

Condition Name

Condition Name for VENLAFAXINE HYDROCHLORIDE
Intervention	Trials
Depression	41
Major Depressive Disorder	36
Healthy	16
Depressive Disorder, Major	9

Condition MeSH

Condition MeSH for VENLAFAXINE HYDROCHLORIDE
Intervention	Trials
Depression	103
Depressive Disorder	89
Depressive Disorder, Major	61
Disease	43

Clinical Trial Locations for VENLAFAXINE HYDROCHLORIDE

Trials by Country

Trials by Country for VENLAFAXINE HYDROCHLORIDE
Location	Trials
United States	370
Canada	53
China	33
Japan	22
Australia	19

Trials by US State

Trials by US State for VENLAFAXINE HYDROCHLORIDE
Location	Trials
Pennsylvania	26
California	24
New York	23
Massachusetts	17
Florida	16

Clinical Trial Progress for VENLAFAXINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for VENLAFAXINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	4
PHASE2	2

Clinical Trial Status

Clinical Trial Status for VENLAFAXINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	142
Recruiting	19
Unknown status	18

Clinical Trial Sponsors for VENLAFAXINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for VENLAFAXINE HYDROCHLORIDE
Sponsor	Trials
Wyeth is now a wholly owned subsidiary of Pfizer	19
National Institute of Mental Health (NIMH)	15
New York State Psychiatric Institute	9

Sponsor Type

Sponsor Type for VENLAFAXINE HYDROCHLORIDE
Sponsor	Trials
Other	241
Industry	90
NIH	33

Last updated: July 26, 2026

Venlafaxine Hydrochloride Clinical Trials Update, Market Analysis, and Revenue Projections (Generics vs Brand)

Executive summary

Venlafaxine hydrochloride is an established oral SNRI (serotonin-norepinephrine reuptake inhibitor) with broad generic availability in most markets. Clinical activity is now dominated by (1) bioequivalence and formulation work for generic applicants, (2) small-scale mechanistic or comparative studies, and (3) limited label-expansion efforts rather than new-to-market development. Market growth is driven mainly by population aging and persistence of treatment for major depressive disorder (MDD) and anxiety disorders, with margin compression from generic competition. Revenue projections track long-term volume stability with declining ex-manufacturer pricing in most geographies; branded share is largely confined to legacy markets or short-duration niche channels where authorized brands retain pricing power.

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What is venlafaxine hydrochloride used for and what is the current clinical pipeline focus?

Venlafaxine hydrochloride is used primarily for:

• Major depressive disorder (MDD)
• Generalized anxiety disorder (GAD)
• Social anxiety disorder (SAD)
• Panic disorder (PD)

Clinical pipeline reality: late-stage “new MOA” development is not the dominant theme. Most current trial work is feasibility, comparator, or bioequivalence-type research supporting commercial supply, regulatory maintenance, or line extensions (such as modified-release positioning and patient adherence strategies).

Key therapeutic area and endpoints commonly tested

• Depression symptom scales (HAM-D, MADRS, CGI-S)
• Anxiety scales (GAD-7, HAM-A)
• Panic-related measures (panic frequency/severity)
• Safety and tolerability: discontinuation symptoms, blood pressure changes, sexual dysfunction rates
• Pharmacokinetic comparability: Cmax, Tmax, AUC, and exposure variability

Formulation scope in current trial designs

• Immediate-release vs extended-release comparative studies
• Dose-ranging adherence and tolerability comparisons
• Switch studies (patients moving between formulations, and between SNRIs)

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What clinical trials are currently active or recently completed for venlafaxine hydrochloride?

Featured-snippet answer: Trial activity is concentrated in regulatory-support and comparative studies rather than major new pivotal programs, with endpoints focused on efficacy comparability and pharmacokinetic/safety alignment.

What counts as “clinical trials activity” now

1. Bioequivalence and PK bridging
   These trials test generic/manufacturer equivalence under fed/fasted conditions or with multiple dose strengths.
2. Comparative effectiveness trials
   Head-to-head designs against other antidepressants (often SSRIs/SNRIs) or switching strategies.
3. Discontinuation and withdrawal characterization
   Studies that assess tapering regimens, symptom monitoring, and patient-reported outcomes.
4. Real-world or pragmatic studies
   Not always labeled as “clinical trials” in promotional feeds, but frequently registered as interventional or prospective observational designs.

Common registration patterns

• “Randomized, double-blind, placebo-controlled” is less frequent in late-stage work.
• “Open-label” switch and tolerability studies are common.
• Most studies are multi-center but often regionally bounded due to recruitment economics.

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When do ongoing venlafaxine hydrochloride trials complete and how does that affect market timing?

Featured-snippet answer: Near-term market timing impact is limited because most new trial completions support generic/regulatory maintenance rather than new commercial exclusivity.

Commercial relevance by trial type

• Bioequivalence completion dates influence filing schedules for ANDAs/variations, not brand re-launches.
• Comparative small studies can affect guideline adoption and payer preference in select markets, but rarely reset pricing power.
• Switching/discontinuation studies can increase formulary stickiness for continuation protocols, but do not typically change patent landscapes.

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What patents protect venlafaxine hydrochloride, and how strong is the patent estate?

Featured-snippet answer: Venlafaxine hydrochloride’s original patents have long since expired in major jurisdictions; the competitive legal field is now dominated by secondary patents (formulation, process, crystal form, specific salt/polymorph variants where applicable) and by packaging or method claims that are less frequently asserted in bulk litigations.

Patent estate pattern for mature small molecules

• Primary API patents: expired
• Extended patent layers: sporadic and often jurisdiction-specific
• Common litigation triggers in mature SNRIs:
  • Shelf-life or stability-related formulations
  • Modified-release or specific manufacturing methods
  • Packaging configurations and patient compliance claims

Practical implication for developers

• In most markets, the path of least resistance for entry is generic equivalence, not design-around IP.
• Where secondary patents exist, enforcement tends to be targeted by compound/strength/formulation rather than the base API.

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What is the Orange Book status of venlafaxine hydrochloride in the US?

Featured-snippet answer: Venlafaxine hydrochloride is generally supported by multiple ANDA listings, reflecting broad generic availability; active exclusivity in the US is typically limited and does not resemble “brand-protecting” leverage for a late-stage incumbent.

How to interpret Orange Book entries for this drug class

• Many listings will show:
  • Generic approved products with “therapeutic equivalence” designations
  • Patent-expiration fields tied to formulation or method patents (if any remain)
  • Federal and state market exclusivity often not the driver in late lifecycle

Regulatory implication

• Without a current brand exclusivity wall, new approvals usually proceed via ANDA amendments, product line expansions, or substitutions to manage supply.

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Are there Paragraph IV challenges for venlafaxine hydrochloride?

Featured-snippet answer: Paragraph IV challenges are not a structural feature of venlafaxine hydrochloride competition at current market maturity; disputes tend to be sporadic and tied to specific product strengths, dosage forms, or secondary patents.

How Paragraph IV risk manifests today

• If a secondary patent exists for a specific extended-release formulation strength or stability claim, challengers may file with certifications aligned to that patent.
• Settlement patterns, when they occur, typically aim to narrow product-level entry timing rather than block the molecule entirely.

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What generic entry risks exist for venlafaxine hydrochloride?

Featured-snippet answer: The main risks are product-specific IP (if any secondary patents remain in a jurisdiction), manufacturing compliance and bioequivalence performance, and payer formulary friction rather than a broad molecule-wide exclusivity barrier.

Manufacturing/IP barriers

• Scale-up reproducibility for extended-release profiles (if applicable)
• Dissolution consistency and in-process controls
• Stability studies that meet shelf-life specifications for marketed strengths

Regulatory execution risks

• Bioequivalence failures due to absorption variability
• Variation approvals and chemistry changes that trigger bridging data
• Labeling differences that require additional comparability work

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How does venlafaxine hydrochloride market share compare with other SNRIs and antidepressants?

Featured-snippet answer: Venlafaxine competes most directly with duloxetine and other antidepressants in SNRI and broader antidepressant categories. Its market position is typically strong on price and long availability, while duloxetine often maintains differentiation through insurance placement and tolerability perceptions in some payer segments.

Competitive set and typical substitution dynamics

• SNRIs: duloxetine, desvenlafaxine (sits as a common “switch” alternative)
• SSRIs: sertraline, citalopram, escitalopram
• Other agents: mirtazapine and tricyclics for specific patient profiles

Pricing pressure reality

• Generic entry compresses net price.
• Payer formularies often prefer the lowest-cost equivalent, with occasional clinical pathway exceptions.

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What formulations are protected by patents for venlafaxine hydrochloride?

Featured-snippet answer: Where protection persists, it is most often concentrated in secondary attributes tied to dosage form and manufacturing (especially extended-release performance and stability) rather than in the basic API.

Formulation categories likely to carry secondary IP (conceptual risk map)

• Extended-release matrices or microbead technologies (if used by specific legacy brands or later entrants)
• Controlled-release dissolution profiles
• Specific process steps that preserve impurity profiles and stability

Commercially relevant takeaway

• Even if the API is free, product-line patents can delay entry for specific strengths or release technologies in selected jurisdictions.

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What FDA pathway would future entrants use for venlafaxine hydrochloride?

Featured-snippet answer: Most new entrants use ANDA pathways for generic equivalence, with possible 505(b)(2) filings only when there is a meaningful change in formulation, delivery system, or label basis.

Typical regulatory strategy for a mature antidepressant

• ANDA for direct equivalence to a reference listed drug
• Dissolution and PK bridging aligned to formulation differences
• Label and strength expansion via approved supplements

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Clinical safety and discontinuation: what do recent trials and post-marketing studies emphasize?

Featured-snippet answer: Discontinuation symptoms and blood pressure monitoring remain the most clinically managed risks, and they are frequently assessed in tolerability-focused trials and real-world studies.

Safety endpoints commonly monitored

• Treatment-emergent hypertension or sustained BP elevations
• Withdrawal/discontinuation syndrome on tapering
• Sexual dysfunction and GI tolerability
• Suicidality monitoring early in treatment (typical for antidepressant class trials)

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How does venlafaxine hydrochloride commercial performance project over the next 5–10 years?

Featured-snippet answer: Over the next decade, the dominant trajectory is stable or modestly declining revenue due to continued pricing erosion and substitution to the lowest-cost generics, offset partially by volume from ongoing depression/anxiety prevalence and aging demographics.

Projection framework (generic mature-drug model)

Revenue for mature, generic-dominant products typically follows:

• Net price: down with periodic generics competition and supply shifts
• Volume: flat to slightly up with epidemiology and adherence rates
• Mix: shift between immediate-release and extended-release depending on dosing preference and payer coverage
• Competitive churn: entry/exit of manufacturers changes price temporarily

Scenario projections (directional, not market-specific)

• Base case: low-single-digit volume growth, mid-single-digit net price decline, resulting in mid-to-high-single-digit revenue decline over a multi-year window.
• Upside case: stronger payer adherence programs for SNRI pathways and stable or increased extended-release usage, reducing net price erosion.
• Downside case: aggressive price competition, formulary exclusions by higher-bidding generics, or supply shocks that force broader discounts.

What would change the outlook

• Any regulatory or clinical guideline shift favoring SNRIs over SSRIs in specific subpopulations
• Introduction of differentiated patient-support formulations (not typical without meaningful IP and regulatory strategy)
• Litigation or manufacturing issues affecting supply for large generic holders

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Key market drivers and inhibitors for venlafaxine hydrochloride

Drivers

• Persistent incidence of MDD and anxiety disorders
• Mature prescribing behavior and clinician familiarity
• Broad availability across strengths
• Generic manufacturer scale and supply networks

Inhibitors

• Continued price competition and margin compression
• Adverse-effect burden relative to certain alternatives (patient-reported withdrawal experiences)
• Payer-driven switches to lowest-cost generics or preferred SNRI comparators

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Which companies are most exposed to venlafaxine hydrochloride pricing pressure?

Featured-snippet answer: Exposure is highest for generic manufacturers with large distribution footprints and higher-cost production bases, while low-cost vertically integrated producers typically sustain better margins.

Company exposure map (how to assess, not a claim of ranking)

• Concentration of manufacturing sites and ability to maintain bioequivalence batch quality
• Participation in contracts tied to national accounts
• Diversified portfolio of antidepressants that can buffer margin volatility
• Inventory financing sensitivity during price drops

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Key takeaways

• Venlafaxine hydrochloride has moved into late-lifecycle clinical activity dominated by PK/bioequivalence, comparative, and tolerability-focused studies.
• Patent leverage is limited at the molecule level; any remaining risk tends to be product-specific and secondary.
• Orange Book and US competition are consistent with widespread generic availability, with reduced expectation of exclusivity-driven market holds.
• Revenue trajectory over 5 to 10 years is primarily shaped by continued net price erosion and stable-to-modest volume growth.
• Market winners are likely the lowest-cost, best-supply generics players that can sustain bioequivalence performance and contract pricing.

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FAQs

1. Does venlafaxine hydrochloride have active exclusivity in the US that blocks generics?
2. Are extended-release vs immediate-release venlafaxine generic substitutions covered differently by payers?
3. What discontinuation/tapering schedules are most studied in venlafaxine trials and real-world evidence?
4. What bioequivalence study designs are most common for venlafaxine hydrochloride generic approvals?
5. How do venlafaxine switching patterns compare with duloxetine and desvenlafaxine in comparative effectiveness studies?

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References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-07-26).
2. ClinicalTrials.gov. Venlafaxine hydrochloride studies (registry search results). https://clinicaltrials.gov/ (accessed 2026-07-26).