CLINICAL TRIALS PROFILE FOR PRISTIQ

All Clinical Trials for PRISTIQ

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00401245 ↗	The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms	Completed	Pfizer	Phase 3	2006-12-01	Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.
NCT00824291 ↗	Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2009-02-01	This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.
NCT00887224 ↗	Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder	Completed	Pfizer	Phase 3	2009-06-01	The primary purpose of this study is to compare the long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive Disorder, using a randomized withdrawal design. Randomized withdrawal means that after receiving desvenlafaxine succinate sustained release for a predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial. Subjects will not know to which group they have been assigned. The study consists of an up to 14-day screening period followed by an 8-week open-label period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate sustained release. Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine succinate sustained release at the same dose. Subjects with stable response to treatment at the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or until symptoms of depression return. Following discontinuation at any point after enrollment in the study, subjects will receive two weeks of follow-up monitoring, including one week of blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any subjects who have been taking desvenlafaxine succinate sustained release prior to discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following taper, subjects will be evaluated for one additional week to monitor safety.
NCT00888862 ↗	Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women	Unknown status	McMaster University	Phase 3	2009-06-01	The main objective of this study is to characterize a range of brain activation symptoms associated with depression and response to treatment in midlife men and women with MDD, using MRI and functional MRI. Moreover, in the female sub-group, the investigators will examine whether these brain activation symptoms are related to menopausal symptoms (i.e., hot flashes and night sweats). Also, assessing brain activation before and after the treatment might help to uncover some mechanisms associated with the pathophysiology of depression and menopause.
NCT00888862 ↗	Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women	Unknown status	St. Joseph's Healthcare Hamilton	Phase 3	2009-06-01	The main objective of this study is to characterize a range of brain activation symptoms associated with depression and response to treatment in midlife men and women with MDD, using MRI and functional MRI. Moreover, in the female sub-group, the investigators will examine whether these brain activation symptoms are related to menopausal symptoms (i.e., hot flashes and night sweats). Also, assessing brain activation before and after the treatment might help to uncover some mechanisms associated with the pathophysiology of depression and menopause.

Clinical Trial Conditions for PRISTIQ

Condition Name

Condition Name for PRISTIQ
Intervention	Trials
Major Depressive Disorder	10
Dysthymic Disorder	2
Vasomotor Symptoms	2
Major Depression	2

Condition MeSH

Condition MeSH for PRISTIQ
Intervention	Trials
Depressive Disorder	16
Depression	16
Depressive Disorder, Major	14
Disease	8

Clinical Trial Locations for PRISTIQ

Trials by Country

Trials by Country for PRISTIQ
Location	Trials
United States	93
Canada	20
Colombia	4
Romania	2
Poland	2

Trials by US State

Trials by US State for PRISTIQ
Location	Trials
New York	6
Ohio	5
New Jersey	5
Illinois	4
Florida	4

Clinical Trial Progress for PRISTIQ

Clinical Trial Phase

Clinical Trial Phase for PRISTIQ
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for PRISTIQ
Clinical Trial Phase	Trials
Completed	16
Unknown status	3
Terminated	3

Clinical Trial Sponsors for PRISTIQ

Sponsor Name

Sponsor Name for PRISTIQ
Sponsor	Trials
Pfizer	10
Luye Pharma Group Ltd.	4
Wyeth is now a wholly owned subsidiary of Pfizer	2

Sponsor Type

Sponsor Type for PRISTIQ
Sponsor	Trials
Other	20
Industry	16
NIH	1

Pristiq (desvenlafaxine) Clinical Trials Update, Market Analysis, and Revenue Projections Through Patent and Generic Risk Inflection

Last updated: July 27, 2026

Executive summary: Pristiq (desvenlafaxine) remains a commercially established antidepressant in the SNRI class. Market growth is constrained by an aging brand, ongoing generic competition, and limited upside from incremental line extensions. The near-to-mid-term outlook is driven mainly by (1) demand stability in adult MDD and GAD-eligible patient segments, (2) formulary positioning versus lower-cost generics and competing SNMIs/SSRI/SNRI agents, and (3) residual exclusivity pockets tied to specific formulations and any method-of-use protection that survives Orange Book and related litigation. Without newly disclosed Phase 3 readouts or a new regulatory indication, the earnings case is best modeled as a late-cycle brand with share defense rather than growth acceleration.

What are the latest clinical trial results and pipeline updates for Pristiq (desvenlafaxine)?

Answer: No new, practice-changing Phase 3 efficacy results for desvenlafaxine in MDD/GAD have been established as a current-category driver on the public record through the latest broadly reported clinical-trials updates accessible at the time of this analysis.

Are there active Phase 3 or pivotal studies for Pristiq right now?

Answer: No pivotal Phase 3 program with a clearly attributable, late-stage efficacy readout has been confirmed as a near-term catalyst for label expansion in the information set used for this analysis.

What lower-stage studies are most likely to matter commercially?

Answer: Commercially relevant work for an older brand typically clusters into:

• formulation and bioavailability studies (supporting switch, manufacturing, or line extension)
• comparative effectiveness trials (head-to-head designs are less common for an off-patent brand unless required by payer strategy or to support a new comparative claim)
• special-population studies (renal/hepatic adjustments, elderly tolerability, drug-drug interaction characterization)

How big is the Pristiq market and what share does desvenlafaxine hold in antidepressants?

Answer: The desvenlafaxine market is meaningful but increasingly mature, with competitive pressure dominated by generics and large formulary-controlled antidepressant classes.

What segments drive Pristiq demand?

Answer: Demand is mainly tied to adult Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD) treatment pathways, with prescribing shaped by:

• payer preferred drug lists for SNRI and SSRI alternatives
• switching behavior from brand to generic desvenlafaxine
• tolerance and discontinuation profiles relative to venlafaxine ER and duloxetine

What are the main competitive comparators?

Answer: Competitive pressure comes from:

• generic desvenlafaxine (cost)
• venlafaxine ER (price and clinician familiarity)
• duloxetine and other SNRI competitors
• SSRIs (broader first-line formularies in many systems)

When does Pristiq lose exclusivity and what is the patent expiration timeline for desvenlafaxine?

Answer: Desvenlafaxine’s core brand exclusivity is already largely past, and competitive entry has shifted the brand into a post-exclusivity commercial regime. Remaining value depends on any formulation, method-of-use, or packaging-specific patents that survived and remain listed/defended.

How do you model exclusivity-driven price erosion for late-cycle Pristiq?

Answer: For a mature antidepressant with generic penetration:

• the “inflection” is typically earlier than full brand erosion because payers move aggressively after generic availability
• residual legal protection (if any) mainly affects settlement timing and launch timing rather than long-run class share
• late-cycle uptake becomes payer-driven rather than prescriber-driven

What patents protect Pristiq and which assignees hold the legal estate?

Answer: A complete, citation-backed patent estate map is not provided here because the required Orange Book, patent number list, and litigation/assignment dataset for Pristiq is not present in the input information for this analysis.

What is the Orange Book status of Pristiq (desvenlafaxine) and how many related patents are listed?

Answer: Orange Book listing counts and individual patent identifiers are not provided here because they require the current FDA publication record and patent term-by-term extraction tied to the specific listed drug product strengths and dosage forms.

How many Paragraph IV challenges exist for Pristiq generics and what is the litigation risk?

Answer: Paragraph IV challenge counts and outcomes are not provided here because the necessary docket-level dataset for Pristiq has not been included in the information used to produce this analysis.

What formulations are protected for Pristiq (extended-release tablets) and what changes could extend revenue?

Answer: No formulation-specific protection set is provided here because the analysis requires strength-level mapping of patents to product codes and product-specific exclusivity periods from Orange Book.

Biosimilar risk: is Pristiq exposed to biosimilar competition?

Answer: No. Pristiq is a small-molecule drug (desvenlafaxine), so biosimilars are not applicable. Competitive risk is driven by generic drugs and any protected formulation niches.

How strong is the patent estate for desvenlafaxine and what does that imply for generic entry scenarios?

Answer: The market behavior for Pristiq indicates that any remaining patent leverage is unlikely to create a return to brand-level exclusivity. The realistic generic entry risk is mainly about:

• speed and breadth of generic penetration by strength
• settlement-driven timing of specific launch products
• packaging or formulation “workarounds” that allow faster market share capture

What generic entry risks exist for Pristiq and how should payers price it versus alternatives?

Answer: Generic entry risk is less about “whether” and more about:

• rate of subsequent generic uptake across strengths
• payer contracting dynamics and rebates
• utilization management in antidepressant classes

For pricing strategy, payers typically move to lowest-allowed cost-sharing tiers once generic equivalents are widely available, while still allowing brand use for intolerance or prior authorization pathways.

Commercial projection: revenue and volume forecast for Pristiq through the next 3–5 years

Answer: A late-cycle brand model is appropriate:

• near-term: modest revenue decline or stabilization driven by residual brand demand in prior-authorization and intolerance cohorts, offset by ongoing generic price pressure
• mid-term: continued volume bleed unless new indications, meaningful differentiated formulation, or adverse-coverage shocks for generic supply occur
• downside risk: faster share loss from formulary switches and additional generic competitive intensity

Revenue drivers to model in forecasting

• net price versus generic comparators (contracting and rebate structure)
• formulary inclusion rate and prior authorization stickiness
• adherence and discontinuation rates (SNRI class tolerability)
• prescriber preference shifts versus duloxetine and venlafaxine ER

Scenario analysis for Pristiq (base, upside, downside)

Answer: Use three scenarios based on share and price rather than exclusivity milestones alone.

Scenario	Key assumptions	Expected commercial shape
Base	steady generic share pressure, stable brand access in niche cohorts	slow revenue erosion, moderate volume decline
Upside	payer behavior slows switching; improved tolerability positioning; localized supply stability	revenue flattens then gradual decline
Downside	intensified formulary restrictions and aggressive contracting; increased generic brand switching	faster decline in both volume and net price

What product/label risks could affect utilization of Pristiq?

Answer: Utilization risks for an established antidepressant are mainly clinical and access-related:

• adverse event profiles that drive switching (discontinuation, BP effects in SNIs, nausea, sexual dysfunction)
• payer restrictions that push step therapy
• drug-drug interaction management in polypharmacy populations

Key Takeaways

• Pristiq is a mature desvenlafaxine franchise with commercial upside limited by generic competition dynamics and the absence of clearly identifiable, near-term pivotal label-expansion catalysts in the current public clinical readout set used for this analysis.
• Forecasting should treat Pristiq as a late-cycle brand with continued share erosion risk moderated by formulary positioning, prior authorization outcomes, and intolerance-related brand persistence.
• The core determinant of trajectory is not biosimilar exposure but generic penetration tempo, contracting leverage, and any surviving formulation/method-of-use protections tied to specific product codes.

FAQs

1) Does Pristiq have any ongoing Phase 3 trials that could expand its indications?
No practice-changing Phase 3 readouts with a clear label-expansion pathway are established in the available clinical-trials update set used for this analysis.

2) Is Pristiq exposed to biosimilar competition?
No. Desvenlafaxine is a small molecule.

3) What class-level alternatives most threaten Pristiq share?
Generic antidepressants in SNRI/SSRI classes, especially duloxetine and venlafaxine ER.

4) How do payers typically control Pristiq utilization after generic entry?
Through preferred tier placement, step therapy, and prior authorization criteria emphasizing medical necessity or prior failure of lower-cost alternatives.

5) What is the biggest driver of near-term Pristiq revenue change?
Net price and formulary access relative to generic desvenlafaxine and competing SNRIs.

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (FDA publication database).
2. ClinicalTrials.gov. (desvenlafaxine studies and results database).
3. FDA labeling for Pristiq (desvenlafaxine). (Accessed via FDA DailyMed/label repository).