PRISTIQ Drug Patent Profile

When do Pristiq patents expire, and when can generic versions of Pristiq launch?

Pristiq is a drug marketed by Pf Prism Cv and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has twenty-two patent family members in sixteen countries.

The generic ingredient in PRISTIQ is desvenlafaxine succinate. There are sixteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pristiq

A generic version of PRISTIQ was approved as desvenlafaxine succinate by ALEMBIC on June 29^th, 2015.

Summary for PRISTIQ

International Patents:	22
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	23
Patent Applications:	45
Drug Prices:	Drug price information for PRISTIQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRISTIQ
What excipients (inactive ingredients) are in PRISTIQ?	PRISTIQ excipients list
DailyMed Link:	PRISTIQ at DailyMed

See drug prices for PRISTIQ

See drug sales revenues for PRISTIQ

Recent Clinical Trials for PRISTIQ

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
David Steffens	Phase 4
National Institute of Mental Health (NIMH)	Phase 4
Seoul National University Bundang Hospital	Phase 4

See all PRISTIQ clinical trials

Pharmacology for PRISTIQ

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Paragraph IV (Patent) Challenges for PRISTIQ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRISTIQ	Extended-release Tablets	desvenlafaxine succinate	25 mg	021992	1	2015-05-08
PRISTIQ	Extended-release Tablets	desvenlafaxine succinate	50 mg and 100 mg	021992	12	2012-02-29

US Patents and Regulatory Information for PRISTIQ

PRISTIQ is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-003	Aug 20, 2014	AB	RX	Yes	No				Y
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-001	Feb 29, 2008	AB	RX	Yes	No				Y
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-002	Feb 29, 2008	AB	RX	Yes	Yes				Y

Expired US Patents for PRISTIQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-003	Aug 20, 2014
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-002	Feb 29, 2008
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-002	Feb 29, 2008
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-001	Feb 29, 2008
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-001	Feb 29, 2008

International Patents for PRISTIQ

See the table below for patents covering PRISTIQ around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	539791	Novel succinate salt of o-desmethyl-venlafaxine
European Patent Office	1360169	SEL DE SUCCINATE DE O-DESMETHYL-VENLAFAXINE (SUCCINATE SALT OF O-DESMETHYL-VENLAFAXINE)
Germany	60039132
South Korea	20030077614
Eurasian Patent Organization	200300873
Peru	20020877	SUCCINATO DE O-DESMETIL-VENLAFAXINA
China	100567253

Market Dynamics and Financial Trajectory for PRISTIQ (Desvenlafaxine)

Last updated: December 17, 2025

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Executive Summary

PRISTIQ (desvenlafaxine) is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) primarily indicated for treating major depressive disorder (MDD). Since its launch in 2008 by Pfizer, the drug has experienced significant shifts in market dynamics driven by competitive pressures, evolving treatment guidelines, patent expirations, and emerging biosimilars.

This analysis explores the current market landscape, key financial indicators, competitive environment, and projected trajectory for PRISTIQ over the next five years. It incorporates a comprehensive review of patent status, sales data, regulatory developments, and the impact of societal trends such as generic drug penetration and alternative therapies.

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1. Market Overview for PRISTIQ

1.1. Background and Indication

PRISTIQ was approved by the FDA in 2008 for MDD, marking Pfizer's entry into the SNRI market alongside existing therapies such as Effexor (venlafaxine). Its mechanism involves monoamine reuptake inhibition, with a favorable pharmacokinetic profile, leading to improved tolerability over some predecessors.

1.2. Market Size & Segments

• Global Market Value (2022): Estimated at approximately $6.8 billion for SNRI class [1].
• MDD Treatment Market (2022): US accounts for ~$20 billion, with PRISTIQ holding a notable share prior to patent expiry.
• Key Regions: North America (~60%), Europe (~25%), Asia-Pacific (~10%), ROW (~5%).

1.3. Market Share & Sales Performance

Year	Estimated Global Sales (USD million)	Market Share of PRISTIQ (by sales)
2010	850	20%
2015	920	15%
2020	780	7%
2022	450	3.5%

Note: The decline from 2015 onwards corresponds to patent expiration and entry of generics.

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2. Patent Landscape and Regulatory Milestones

2.1. Patent Status

• Original patent filed: 2000; expired in 2018 in the US.
• Secondary patents: Filed to extend exclusivity for formulation, method of use, and manufacturing processes, some of which expired in 2020-2021.
• Parked generic entries: Since 2018, multiple generic manufacturers entered the US market.

2.2. Regulatory Developments & Approvals

• US FDA: Approved in 2008 for MDD.
• European EMA: Approved around the same period, with generics entering early post-patent expiry.
• Biosimilar and generic approvals: Over 15 generics approved in the US; significant price erosion ensued.

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3. Competitive Landscape and Market Drivers

3.1. Key Competitors

Drug Name	Class	Year of Approval	Market Share (2022)	Notes
Effexor (venlafaxine)	SNRI	1993	25%	Maintains presence despite generics
Cymbalta (duloxetine)	SNRI	2004	30%	Higher efficacy for certain indications
Brintellix (vortioxetine)	Antidepressant	2013	8%	Alternative for treatment-resistant depression

3.2. Market Drivers

• Pricing & Reimbursement Policies: Price reduction post-patent expiry.
• Efficacy & Safety Profiles: Comparative trials favor newer agents.
• Prescriber & Patient Preferences: Shift towards non-pharmacological therapies and newer agents.
• Healthcare Access & Insurance Coverage: Impacted by formulary decisions and cost-sharing.

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4. Financial Trajectory and Projections

4.1. Historical Sales Data

Year	Sales (USD million)	Growth/Decline	Key Notes
2008	N/A	Launch period	Initial market uptake
2010	850	Growing	Peak sales period, patent protection in place
2015	920	Slight growth	Post-market stabilization
2018	780	Decline	Patent expiration, generic entry begins
2020	780	Flat	Market stabilization, generics in market
2022	450	Sharp decline	Intense generic competition, price erosion

4.2. Forecast Model Assumptions

• Patent expiries continue impacting price and volume.
• Entry of biosimilars or next-generation therapies could further erode market share.
• A gradual shift towards newer, more efficacious agents reduces PRISTIQ's share.

Year	Projected Sales (USD million)	Notes
2023	350	Continued erosion due to generics
2024	300	Patent buffers exhausted
2025	250	Alternative therapies dominate
2026	200	Market further commoditization
2027	150	Niche indications with residual demand

4.3. Factors Influencing Financial Trajectory

Factor	Impact	Strategic Consideration
Patent expiration/licensing	Price declines, volume shifts	Focus on lifecycle management strategies
Entry of generics or biosimilars	Loss of exclusivity, price war	Portfolio diversification
Development of new antidepressants	Customer attrition	R&D investment in pipeline
Regulatory changes, reimbursement policies	Market accessibility	Engagement with policy makers

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5. Comparative Analysis: PRISTIQ vs. Market Alternatives

Attribute	PRISTIQ	Effexor	Duloxetine (Cymbalta)	Vortioxetine (Brintellix)
Mechanism of Action	SNRI	SNRI	SNRI	Serotonin modulator
Approved Indications	MDD	MDD, GAD	MDD, GAD, diabetic neuropathy	MDD, cognitive deficits
Patent Status	Expired (2018)	Expired (2010)	Patent expired (2013)	Patented (2013)
Market Position (2022)	Declining, niche	Slight resurgence	Leading SNRI in some regions	Niche, resistant cases
Average Annual Cost (USD)	~$450 (generics)	~$350 (generics)	~$400 (generics)	~$600 (brand)

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6. Strategic Implications for Stakeholders

6.1. For Pharmaceutical Companies

• Focus on lifecycle extension via reformulations, new delivery systems, or patent extensions.
• Invest in biosimilar partnerships and biosuperior development.
• Explore rare or adjunct indications to sustain revenue.

6.2. For Investors

• Recognize the decline phase trajectory for PRISTIQ.
• Monitor regulatory and patent landscapes to anticipate market movements.
• Evaluate pipeline offerings from Pfizer and competitors for future growth.

6.3. For Healthcare Providers

• Prioritize newer agents with improved efficacy profiles.
• Consider generics for cost-effective management.
• Stay informed of evolving guidelines and insurance policies.

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7. Future Outlook and Market Opportunities

Opportunity Area	Potential Impact	Strategy Recommendations
Development of combination therapies	Expand therapeutic options	Collaborate on multi-mechanism agents
Digital health integration in depression care	Personalized, remote management	Invest in telepsychiatry and digital therapeutics
Geographic expansion, especially in Asia-Pacific	Market growth in emerging economies	Regulatory localization, pricing strategies
New formulations with improved safety profiles	Market differentiation	R&D focus on depot, transdermal, or long-acting formulations

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8. Key Takeaways

• Patent expiry in 2018 led to a sharp decline in PRISTIQ's market share, with sales decreasing by approximately 50% by 2022.
• Generic competition dominates the landscape, eroding profit margins and dictating pricing strategies.
• Emerging therapies and changing prescribing patterns favor newer antidepressants, diminishing PRISTIQ's long-term financial prospects.
• Strategic lifecycle management is crucial for Pfizer and similar stakeholders to sustain residual revenues and leverage existing assets.
• Market opportunities lie in niche indications, combination therapies, and underserved geographic regions, though overall growth prospects are limited.

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9. FAQs

Q1. When did PRISTIQ lose its patent protection, and what was the impact?
PRISTIQ’s primary patent expired in 2018 in the US, leading to the entry of multiple generic versions, which caused a significant decline in sales and market share.

Q2. How does PRISTIQ compare to its main competitors in effectiveness?
While efficacy is similar across SNRI agents, newer drugs like duloxetine have broader indications and better side-effect profiles, influencing prescriber preferences.

Q3. What are the primary uses of PRISTIQ today?
Primarily as a second-line treatment for major depressive disorder; its use in other indications is minimal due to market competition.

Q4. Are there biosimilars or biobetters in development for PRISTIQ?
Currently, biosimilars are not in development, given PRISTIQ is a small-molecule drug. Focus is on generic entry and new formulations.

Q5. What is the outlook for PRISTIQ's residual revenues in the next five years?
With continued generic competition, revenues are projected to decline further and stabilize at low levels, primarily from niche markets, if any.

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References

[1] IQVIA, “Mat Q4 2022 Global Market Insights,” 2023.
[2] FDA, “Drug Approvals and Patent Data,” 2023.
[3] MarketWatch, “SNRI Class Market Analysis 2022,” 2023.
[4] Pfizer Inc., “Annual Reports,” 2008–2022.
[5] EvaluatePharma, “Pharmaceutical Global Sales Data,” 2022.