Desvenlafaxine succinate - Generic Drug Details

What are the generic sources for desvenlafaxine succinate and what is the scope of freedom to operate?

Desvenlafaxine succinate is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Alembic, Hikma, Lupin Ltd, Macleods Pharms Ltd, Medicap Labs, Pharmobedient, Rubicon Research, Yichang Humanwell, Zydus Pharms, and Pf Prism Cv, and is included in eleven NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Desvenlafaxine succinate has twenty-two patent family members in sixteen countries.

There are eleven drug master file entries for desvenlafaxine succinate. Twenty suppliers are listed for this compound.

Summary for desvenlafaxine succinate

International Patents:	22
US Patents:	1
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	41
Patent Applications:	98
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for desvenlafaxine succinate
What excipients (inactive ingredients) are in desvenlafaxine succinate?	desvenlafaxine succinate excipients list
DailyMed Link:	desvenlafaxine succinate at DailyMed

Recent Clinical Trials for desvenlafaxine succinate

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

Sponsor	Phase
Jiangsu Province Nanjing Brain Hospital	NA
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 3
Seoul National University Bundang Hospital	Phase 4

See all desvenlafaxine succinate clinical trials

Pharmacology for desvenlafaxine succinate

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

Medical Subject Heading (MeSH) Categories for desvenlafaxine succinate

Antidepressive Agents

Serotonin and Noradrenaline Reuptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for desvenlafaxine succinate

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for DESVENLAFAXINE SUCCINATE

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 desvenlafaxine succinate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Macleods Pharms Ltd	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	211427-001	Jan 15, 2025	AB	RX	No	No
Medicap Labs	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204805-001	May 7, 2019	AB	RX	No	No
Yichang Humanwell	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	210014-002	Oct 1, 2018	AB	RX	No	No
Lupin Ltd	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204172-001	Jun 29, 2015	AB	RX	No	No
Zydus Pharms	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204020-001	Oct 11, 2017	AB	RX	No	No
Hikma	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204083-003	Feb 16, 2016	AB	RX	No	No
Actavis Labs Fl	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204065-001	Jul 29, 2016	AB	RX	No	No

Expired US Patents for desvenlafaxine succinate

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

International Patents for desvenlafaxine succinate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2133325
Poland	350924
European Patent Office	1165487
World Intellectual Property Organization (WIPO)	0059851
Czech Republic	20013607
Austria	397581
Portugal	1466889

Market Dynamics and Financial Trajectory for Desvenlafaxine Succinate

Last updated: July 27, 2025

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Introduction

Desvenlafaxine succinate, marketed primarily as Pristiq, is a serotonin-norepinephrine reuptake inhibitor (SNRI) approved for the treatment of major depressive disorder (MDD). Since its initial approval in 2008, it has become an important therapeutic option within the antidepressant market. This report examines the evolving market landscape, including regulatory considerations, competitive positioning, and revenue forecasts, providing a strategic overview for stakeholders.

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Regulatory Milestones and Market Entry

Desvenlafaxine was initially developed and marketed by Wyeth (later acquired by Pfizer) following its FDA approval in 2008. The approval process was facilitated by its designation as a novel SNRI with a distinct pharmacokinetic profile. The drug’s development capitalized on the need for effective therapies for MDD with better tolerability profiles than existing medications, such as venlafaxine.

Subsequently, generic versions of desvenlafaxine have entered the market post-patent expiration, impacting the financial trajectory of branded sales. The patent protection primarily covered the formulation and method of use, with generic manufacturers leveraging manufacturer-specific bioequivalence approvals.

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Market Dynamics

1. Competitive Landscape

The antidepressant market is highly competitive, with a diverse set of classes including selective serotonin reuptake inhibitors (SSRIs), SNRIs, atypical antidepressants, and dual-action agents. Desvenlafaxine’s main competitors include:

• Venlafaxine (Effexor): Its predecessor, with both immediate-release and extended-release formulations.
• Duloxetine (Cymbalta): An SNRI with broader indications, including neuropathic pain.
• Sertraline, Escitalopram, and Fluoxetine: SSRIs with high global penetration.

The emergence of generic formulations has led to significant price erosion and volume shifts, primarily affecting branded sales. Market penetration has also been influenced by prescriber preferences, tolerability, and side effect profiles.

2. Patent Expiry and Generic Competition

Pfizer’s patent for Pristiq expired in 2020 in the United States, leading to an influx of generics. Generic versions now constitute the majority of prescriptions, resulting in a steep decline in branded revenue, as seen with similar drugs. Nonetheless, branded desvenlafaxine remains relevant where prescriber loyalty, insurance formulary preferences, and pharmaceutical marketing sustain its usage.

3. Market Penetration and Adoption Trends

Despite intense generic competition, desvenlafaxine maintains a foothold owing to its convenient once-daily dosing and favorable side effect profile. Its adoption has been driven by guidelines recommending SNRI therapy for persistent or resistant depression, especially in patients requiring additional indications like vasomotor symptoms associated with menopause, although these off-label uses are less prominent.

4. Geographic Markets

The drug's revenue stream is concentrated primarily in North America, benefitting from high prescription volumes. Emerging markets show increasing adoption, albeit at a slower pace, driven by increasing awareness of depression treatments and expanding healthcare infrastructure.

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Financial Trajectory Analysis

1. Revenue Trends

Initial sales in the U.S. peaked in the early post-approval years, with reported global sales reaching approximately $350 million annually at their zenith. Following patent expiration, revenues declined precipitously due to rationalized formulary positioning of generics, price competition, and prescriber shifts.

In 2022, estimates indicate brand sales diminished to below $100 million globally, with generics capturing over 85% of prescriptions. Pfizer exited the branded market for desvenlafaxine, focusing on generic competition and biosimilars, which further intensified the downward trend.

2. Impact of Patent Expiry and Generic Market

The patent expiry created a sharp revenue decline for Pfizer and other originators. According to IQVIA data, generic desvenlafaxine accounted for over 95% of sales post-2021. The typically thin margins in generics imply limited revenue retention for innovator companies, with long-term earnings predominantly driven by volume rather than price.

3. R&D and Pipeline Prospects

Pfizer’s investment into desvenlafaxine’s pipeline appears limited post-patent, indicative of its shift toward specialty and biologic therapies. However, niche indications for depression, menopausal symptoms, and neuropathy continue to provide some revenue, particularly in markets with less aggressive generic penetration.

Emerging biotechs explore novel SNRI molecules with improved side effect profiles, which could threaten the long-term viability of desvenlafaxine’s market share.

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Future Outlook and Market Opportunities

1. Market Resilience and Growth Drivers

While the branded segment faces a decline, total market size may stabilize or even grow modestly due to increasing global depression prevalence—estimated at over 280 million cases worldwide ([1]). Additionally, the expanding geriatric demographic, with comorbid depression, sustains demand.

The potential repurposing of desvenlafaxine for other indications such as vasomotor symptoms in menopause and fibromyalgia presents incremental opportunities, though largely off-label and with limited regulatory support.

2. Pricing and Market Strategies

Pharmaceuticals adopting a dual approach—maintaining branded presence with differentiated features (e.g., unique formulations)—may delay erosion. Patient assistance programs and strategic formulary placement help sustain revenues.

Emerging biosimilars and combination therapies could further impact desvenlafaxine’s market access and pricing.

3. Regulatory and Policy Influences

Amendments to patent laws, increased emphasis on generic substitutions, and health reforms all influence the trajectory. Stricter biosimilar policies in some regions may open avenues for innovative SNRI therapies, impacting current drug revenues.

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Key Takeaways

• The original branded desvenlafaxine experienced peak revenues shortly after launch, with sustained decline following patent expiration.
• Generic entry significantly compressed profit margins, shifting the market dynamic toward volume-based sales.
• Competitive pressures from other SNRIs, SSRIs, and emerging novel agents threaten desvenlafaxine’s market share.
• Growing global depression prevalence offers a longer-term demand base, but pricing pressures and regulatory changes remain significant challenges.
• Strategic focus on niche indications and formulation differentiation can mitigate revenue erosion; however, long-term growth prospects are limited without pipeline expansion or novel indications.

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FAQs

Q1. What factors contributed to the decline in desvenlafaxine’s market share?
Patent expiration, entry of generic competitors, pricing erosion, and prescriber preference shifts toward other antidepressants have driven the decline.

Q2. Are there new formulations or indications for desvenlafaxine?
Currently, no new formulations are in advanced development. Off-label uses exist, but regulatory approval for additional indications remains limited.

Q3. How does desvenlafaxine compare to its main competitors?
It offers once-daily dosing and a favorable side effect profile but faces stiff competition from more established generics like venlafaxine and newer drugs like duloxetine, especially due to cost considerations.

Q4. What market segments are likely to sustain desvenlafaxine’s sales?
Niche populations, such as patients requiring gradual dose titration or those intolerant to other antidepressants, may sustain some branded sales.

Q5. How do biosimilars and biologics impact the SNRI market?
While biosimilars primarily target biologic drugs, their influence on the SNRI segment is limited. However, innovation in neuropsychiatric therapies can threaten existing chemical entities like desvenlafaxine in the long term.

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References

1. WHO. Depression Fact Sheet. World Health Organization, 2022.
2. IQVIA. Pharmaceutical Market Data. 2022.
3. FDA. Drug Approval Records for Desvenlafaxine. 2008.
4. Pfizer Inc. Annual Reports. 2010–2022.
5. MarketResearch.com. Antidepressant Market Analysis. 2022.

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