Last Updated: May 25, 2026

CLINICAL TRIALS PROFILE FOR EFFEXOR XR


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505(b)(2) Clinical Trials for EFFEXOR XR

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for EFFEXOR XR

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.
NCT00043550 ↗ Treatments for Depression: Drug Versus Psychotherapy Completed National Institute of Mental Health (NIMH) Phase 3 2001-11-01 This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®), venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which is more effective in treating major depression.
NCT00043550 ↗ Treatments for Depression: Drug Versus Psychotherapy Completed University of Pennsylvania Phase 3 2001-11-01 This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®), venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which is more effective in treating major depression.
NCT00045916 ↗ Optimizing Electroconvulsive Therapy for Depression Completed National Institute of Mental Health (NIMH) Phase 4 2001-02-01 This study will evaluate the effectiveness of electroconvulsive therapy (ECT) administered with medication for the treatment of a major depressive episode (unipolar or bipolar) and will compare two types of ECT.
NCT00045916 ↗ Optimizing Electroconvulsive Therapy for Depression Completed New York State Psychiatric Institute Phase 4 2001-02-01 This study will evaluate the effectiveness of electroconvulsive therapy (ECT) administered with medication for the treatment of a major depressive episode (unipolar or bipolar) and will compare two types of ECT.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for EFFEXOR XR

Condition Name

Condition Name for EFFEXOR XR
Intervention Trials
Depression 15
Healthy 12
Major Depressive Disorder 10
Depressive Disorder, Major 4
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Condition MeSH

Condition MeSH for EFFEXOR XR
Intervention Trials
Depression 33
Depressive Disorder 28
Depressive Disorder, Major 15
Disease 11
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Clinical Trial Locations for EFFEXOR XR

Trials by Country

Trials by Country for EFFEXOR XR
Location Trials
United States 115
Japan 47
China 12
Canada 12
United Kingdom 3
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Trials by US State

Trials by US State for EFFEXOR XR
Location Trials
New York 10
Florida 8
California 6
North Carolina 6
Missouri 6
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Clinical Trial Progress for EFFEXOR XR

Clinical Trial Phase

Clinical Trial Phase for EFFEXOR XR
Clinical Trial Phase Trials
Phase 4 23
Phase 3 9
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for EFFEXOR XR
Clinical Trial Phase Trials
Completed 48
Unknown status 4
Withdrawn 4
[disabled in preview] 5
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Clinical Trial Sponsors for EFFEXOR XR

Sponsor Name

Sponsor Name for EFFEXOR XR
Sponsor Trials
Wyeth is now a wholly owned subsidiary of Pfizer 7
Teva Pharmaceuticals USA 5
National Institute of Mental Health (NIMH) 5
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Sponsor Type

Sponsor Type for EFFEXOR XR
Sponsor Trials
Other 52
Industry 32
NIH 10
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Effexor XR (venlafaxine extended-release) clinical trials update, market analysis, and exclusivity-driven launch projections (2026)

Last updated: May 21, 2026

Executive summary
Effexor XR is an established, systemically dosed serotonin-norepinephrine reuptake inhibitor (SNRI) with long-running generic availability in major markets. For 2026 planning, the relevant risk is not Phase 3 pipeline success, but generic erosion, brand share compression, and any remaining patent or regulatory exclusivity exposure tied to specific controlled-release manufacturing/process, dosage-strength coverage, or line-extensions in particular jurisdictions. A precise, litigation- and Orange-Book-calibrated projection requires source-level patent and FDA listing data that is not present in the input.

What clinical trials update is available for Effexor XR (venlafaxine ER) in 2025-2026?

No trial update can be produced from the provided information.

Are there new Phase 3 studies for Effexor XR vs immediate-release venlafaxine?

No trial update can be produced from the provided information.

Are there new trials for Effexor XR in depression subtypes or treatment-resistant depression?

No trial update can be produced from the provided information.

Are there new studies in anxiety disorders, panic disorder, or PTSD using Effexor XR?

No trial update can be produced from the provided information.

What is the current market size and sales trend for Effexor XR (venlafaxine ER)?

No market-size or trend figures can be produced from the provided information.

How has Effexor XR revenue evolved post-generic entry?

No market data is provided.

What share does Effexor XR hold today versus venlafaxine IR and branded comparators?

No comparative share data is provided.

Where is Effexor XR sold geographically and which geographies matter most?

No regional sales breakdown is provided.

When does Effexor XR lose exclusivity and when do generics face regulatory or patent barriers?

No exclusivity or expiration timeline can be produced from the provided information.

What patents protect Effexor XR (venlafaxine ER) in the US?

No patent numbers, expiration dates, or claims can be enumerated.

What is the Orange Book status of Effexor XR?

No Orange Book listing details are provided.

Do any Effexor XR strengths, dosage forms, or AB-rated products have different expiry dates?

No strength-specific exclusivity information is provided.

Is there any risk of ongoing patent litigation affecting generic entry of venlafaxine ER?

No litigation docket, settlement terms, or stay dates are provided.

How strong is the patent estate for Effexor XR, and what formulation patents could matter?

No patent-strength assessment can be produced from the provided information.

What formulation and manufacturing method patents could protect extended-release characteristics?

No formulation/method patent record is provided.

What generic entry risks exist for venlafaxine ER?

No Paragraph IV status or injunction history is provided.

How does Effexor XR’s patent position compare with the patent estates for other SNRIs?

No comparative estate data is provided.

Are there any Paragraph IV challenges for Effexor XR that could change launch timing?

No Paragraph IV filing list or resolution details are provided.

Which companies are challenging Effexor XR generics?

No challenger identities are provided.

What settlement agreements or consent judgments affect generic launch?

No settlement terms or timing impacts are provided.

How does Effexor XR compare with other SNRI brands and long-acting antidepressants?

No evidence-based positioning analysis can be produced from the provided information.

Effexor XR vs Cymbalta (duloxetine): dosing convenience and safety differentiation

No head-to-head or commercial data is provided.

Effexor XR vs Pristiq (desvenlafaxine ER): efficacy perceptions and switching

No switching and market data is provided.

Effexor XR vs generic venlafaxine ER: pricing pressure and formulary status

No payer formulary data is provided.

What regulatory status does Effexor XR have with FDA pathways, ANDAs, and labeling?

No FDA regulatory status details are provided.

Is Effexor XR listed as reference drug for any ANDA scheme?

No listing details are provided.

What label changes or REMS/PMRs affect commercialization?

No label- or compliance-related data is provided.

Are there any pediatric exclusivity, 505A, or supplement-based exclusivities tied to Effexor XR?

No exclusivity supplements are provided.

What market projections are realistic for Effexor XR through 2027?

No numeric projections can be produced from the provided information.

Base-case unit and price trajectory under continued generic erosion

No baseline revenue/volume inputs are provided.

Upside scenarios tied to line extensions, managed-care preferences, or safety updates

No scenario drivers are provided.

Downside scenarios tied to further formulary exclusions or price compression

No scenario drivers are provided.

Key Takeaways

  • Effexor XR is an established venlafaxine extended-release SNRI; 2026 planning focus is exclusivity and competitive erosion, not a late-stage “approval-driven” market inflection.
  • No clinical trials, patent, Orange Book, litigation, or FDA regulatory facts were provided, so a source-based update and timed launch projection cannot be produced.

FAQs

  1. What is the current Orange Book listing for Effexor XR (venlafaxine ER) by strength and dosage form?
  2. Which companies hold ANDAs for venlafaxine extended-release and what are their approval dates?
  3. Are there any active patent litigations involving Effexor XR generics in the US?
  4. What are the highest-frequency labeled adverse events and how do they influence formulary placement?
  5. How does Effexor XR market performance compare with duloxetine ER and desvenlafaxine ER in US managed care?

References

  1. No sources were provided in the prompt.

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