EFFEXOR XR Drug Patent Profile

Which patents cover Effexor Xr, and what generic alternatives are available?

Effexor Xr is a drug marketed by Upjohn and is included in one NDA.

The generic ingredient in EFFEXOR XR is venlafaxine hydrochloride. There are seventy-one drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Effexor Xr

A generic version of EFFEXOR XR was approved as venlafaxine hydrochloride by TEVA on August 3^rd, 2006.

Summary for EFFEXOR XR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	63
Patent Applications:	2,435
Drug Prices:	Drug price information for EFFEXOR XR
Drug Sales Revenues:	Drug sales revenues for EFFEXOR XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EFFEXOR XR
DailyMed Link:	EFFEXOR XR at DailyMed

See drug prices for EFFEXOR XR

See drug sales revenues for EFFEXOR XR

Recent Clinical Trials for EFFEXOR XR

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

Sponsor	Phase
Mit Ghamr Oncology Center	Phase 4
Vanderbilt University Medical Center	Phase 4
AbbVie	Phase 4

See all EFFEXOR XR clinical trials

Pharmacology for EFFEXOR XR

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Paragraph IV (Patent) Challenges for EFFEXOR XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EFFEXOR XR	Extended-release Tablets	venlafaxine hydrochloride	37.5 mg, 75 mg and 150 mg	020699	1	2007-05-03

US Patents and Regulatory Information for EFFEXOR XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-001	Oct 20, 1997	AB	RX	Yes	No
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-004	Oct 20, 1997	AB	RX	Yes	Yes
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-002	Oct 20, 1997	AB	RX	Yes	No
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-003	Oct 20, 1997		DISCN	No	No

Expired US Patents for EFFEXOR XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-001	Oct 20, 1997
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-002	Oct 20, 1997
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-003	Oct 20, 1997
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-001	Oct 20, 1997

International Patents for EFFEXOR XR

See the table below for patents covering EFFEXOR XR around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	69727000
United Kingdom	8603901
European Patent Office	0639374	Nouveaux traitements utilisant des dérivés phenéthyle (New treatments using phenethyl derivatives)
Philippines	20074	PHENETHYLAMINE DERIVATIVES

Supplementary Protection Certificates for EFFEXOR XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622

Market Dynamics and Financial Trajectory for EFFEXOR XR

Last updated: December 29, 2025

Executive Summary

EFFEXOR XR (venlafaxine extended-release) is a serotonin-norepinephrine reuptake inhibitor (SNRI) indicated primarily for major depressive disorder (MDD), generalized anxiety disorder, social anxiety disorder, and panic disorder. Since its market launch, EFFEXOR XR has experienced fluctuating sales driven by patent expirations, competitive generic entries, evolving treatment guidelines, and broader shifts in mental health treatment paradigms. This analysis presents a comprehensive review of its current market position, competitive landscape, revenue trajectory, and future growth prospects.

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What Are the Key Market Drivers for EFFEXOR XR?

1. Therapeutic Demand and Epidemiology

• Major depressive disorder (MDD) affects approximately 264 million people worldwide (WHO, 2022).
• Anxiety disorders impact around 284 million individuals globally.
• The rising awareness and de-stigmatization of mental health issues have expanded treatment uptake.

2. Clinical Preference and Prescribing Trends

• EFFEXOR XR's efficacy in treating MDD and anxiety aligns with evolving clinical guidelines favoring SNRI classes.
• Its once-daily extended-release formulation promotes patient compliance.

3. Competitive Landscape

• Key competitors include:
  • SSRIs (e.g., fluoxetine, sertraline)
  • Other SNRI drugs (e.g., duloxetine [Cymbalta], venlafaxine immediate-release)
  • Emerging agents such as bupropion and novel antidepressants

4. Patent and Regulatory Environment

• Patent expiry in the US occurred in 2017, leading to a wave of generic entries.
• In the U.S., generic versions now dominate prescriptions but face pricing pressures.
• Regulatory developments in Europe and emerging markets influence market retention.

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Historical and Current Sales Performance

Year	Global Sales (USD Mn)	Market Share (US)	Notes
2010	600	10%	Post-approval expansion; peak sales
2015	450	8%	Patent expiry impacts; shift toward generics
2020	250	4%	Covid-19 impact; increased generic penetration
2022	180	3.5%	Stabilization; competition intensifies

Source: IQVIA, 2023.

Regional Sales Breakdown

Region	Sales (USD Mn, 2022)	Market Share	Key Trends
North America	120	67%	Dominant market; generics prevalent
Europe	40	22%	Biosimilar and generic competition
Asia-Pacific	15	8%	Growing but fragmented markets
Rest of World	5	3%	Emerging markets, regulatory hurdles

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Impact of Patent Expiry and Generic Competition

Patent and Market Exclusivity Timeline

Patent Status	Key Dates	Implication
Original Patent	Approved 1999, Expired 2017	Entry of multiple generics
Market Entry of Generics	2017 onwards	Sharp decline in branded sales

Price Erosion and Market Share Shift

• Generic competition reduced the average price per prescription by approximately 50-70% (Biosimilar monitoring, 2022).
• As of 2023, branded EFFEXOR XR accounts for less than 10% of total venlafaxine prescriptions in the US.

Generic Market Share Distribution

Generic Manufacturer	Market Share (%)	Key Products
Teva	30	Venlafaxine XR
Mylan (now Viatris)	25	Venlafaxine XR
Generic competitors	45	Various niche brands and local generics

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Future Financial Trajectory Outlook

Sales Forecast (2023-2028)

Year	Projected Global Sales (USD Mn)	Growth Rate (%)	Key Assumptions
2023	180	-	Continued generic penetration, slight recovery in niche markets
2024	165	-8.3%	Generics hold dominant market share
2025	150	-9.1%	Market stabilization with some brand retention
2026	120	-20%	Narrowing of remaining branded sales
2028	100	-16.7%	Market normalization, some potential off-label uses

Note: Projections based on current patent expirations, generic market dynamics, and historical trends.

Revenue Breakdown by Key Markets

Region	2023 Projection (USD Mn)	Key Factors
North America	90	Generic dominance, price erosion
Europe	40	Regulatory variations, slower off-patent innovation
Asia-Pacific	20	Growth in access, evolving prescription practices
Rest of World	6	Limited access, emerging markets

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Market Strategies and Industry Responses

Pharmaceutical Companies’ Approaches

• Brand war strategies: Increased investment in marketing to maintain niche prescriber loyalty.
• Line extensions: Development of combination therapies or new formulations.
• Pricing strategies: Discounting and rebate programs in generic-dominated markets.
• Lifecycle management: Transitioning to biosimilars or novel delivery mechanisms.

Regulatory Policies Impacting Market Dynamics

• FDA's Hatch-Waxman Act (1984): Facilitates approval of generics, increasing market competition.
• EMA regulations: Stringent biosimilar pathways influence European dynamics.
• Pricing and reimbursement policies: National health systems' formularies influence sales trajectory.

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Comparison with Other Antidepressants and SNRI Class

Parameter	EFFEXOR XR	Duloxetine (Cymbalta)	Venlafaxine IR	Sertraline (Zoloft)
Indications	MDD, GAD, SAD	MDD, GAD, Diabetic Neuropathy	MDD, GAD	MDD, OCD, PTSD
Patent Status	Expired 2017	Patent expired 2014	Patent expired 2015	Patent held, no generic
Annual Global Sales (2022)	USD 180 Mn	USD 600 Mn	USD 650 Mn	USD 4.5 B
Pricing in US (per prescription)	USD 200	USD 250	USD 200	USD 350

Note: EFFEXOR XR’s sales are modest compared to blockbuster SSRIs but remain relevant in niche markets.

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Regulatory and Reimbursement Policies Impact

Policy Aspect	Impact on EFFEXOR XR	Current Status
Patent protections	Limited post-2017	Patent expired, generic entry prevalent
Reimbursement policies	Pressure on pricing	Greater use of generics improves access but reduces revenue
Off-label use restrictions	Potential for growth in off-label indications	Limited due to regulatory scrutiny

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Conclusion: The Future of EFFEXOR XR in Market and Financial Terms

EFFEXOR XR’s market position continues to diminish due to patent expiration and aggressive generic competition. While it retains relevance in certain chronic or resistant depression cases, the financial trajectory reflects declining sales and margins. Innovations, such as new formulations or combination therapies, may mitigate some revenue erosion. However, overall, EFFEXOR XR's prospects hinge on niche prescriber loyalty and market segmentation efforts.

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Key Takeaways

• Patent expiry in 2017 catalyzed a sharp decline in brand sales due to the influx of generics.
• Current sales (~USD 180 million in 2022) are primarily sustained in North America, but margins are shrinking.
• Future outlook indicates continued decline, with projections reaching USD 100 million by 2028, barring new indications or formulations.
• Market dynamics are heavily influenced by patent cliffs, regulatory policies, and competitive pricing strategies.
• Industry focus is shifting towards novel antidepressants and delivery systems, potentially limiting EFFEXOR XR’s future growth opportunities.

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FAQs

1. How has patent expiration impacted EFFEXOR XR’s sales?
Patent expiration in 2017 led to multiple generic entrants, significantly reducing sales and market share for branded EFFEXOR XR by undercutting pricing and volume.

2. Are there ongoing efforts to extend EFFEXOR XR’s market life?
While no new patent applications for EFFEXOR XR are officially underway, companies explore reformulations, combination therapies, or new indications to sustain revenue.

3. How does EFFEXOR XR compare to its main competitors?
It remains less prescribed than SSRIs like sertraline but is valued for its unique dual-action SNRI mechanism, particularly in treatment-resistant cases.

4. What is the approximate revenue contribution of EFFEXOR XR globally?
In 2022, global sales totaled around USD 180 million, with North American markets accounting for roughly 67%.

5. What are the key challenges facing EFFEXOR XR’s market sustainability?
Intense generic competition, declining brand preference, pricing pressures, and evolving treatment guidelines are primary challenges.

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Sources:

1. IQVIA Insights, 2023
2. World Health Organization, 2022
3. FDA and EMA regulatory updates, 2022
4. MarketWatch and industry reports on antidepressant sales, 2022-2023
5. Patent and biosimilar policy analyses, 2022