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. Sixty-eight 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:	4
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	63
Patent Applications:	2,087
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	020699-004	Oct 20, 1997	6,310,101
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-002	Oct 20, 1997	6,274,171*PED
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-003	Oct 20, 1997	6,274,171*PED
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-004	Oct 20, 1997	5,916,923*PED

International Patents for EFFEXOR XR

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1028718	PREPARATION A LIBERATION PROLONGEE (EXTENDED RELEASE FORMULATION CONTAINING VENLAFAXIN)
Poland	318954
Hungary	224617	Venlafaxin-hidrokloridot tartalmazó, nyújtott felszabadulást biztosító gyógyszerforma (EXTENDED RELEASE FORMULATION CONTAINING VENLAFLAXINE HYDROCHLORIDE)
Canada	2305242

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

EFFEXOR XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Effexor XR

Introduction to Effexor XR

Effexor XR, the extended-release form of venlafaxine, is a serotonin and norepinephrine reuptake inhibitor (SNRI) used to treat major depressive disorder, generalized anxiety disorder (GAD), social anxiety disorder, and panic disorder. Here, we delve into the market dynamics and financial trajectory of this medication.

Market Growth and Forecast

The venlafaxine market, which includes Effexor XR, is anticipated to experience significant growth from 2022 to 2029. According to market research, the global venlafaxine market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4% during this period[1].

Drivers of Market Growth

Several factors are driving the growth of the venlafaxine market:

Increasing Prevalence of Mental Health Disorders

The rise in the prevalence of anxiety, social anxiety disorder, and depression is a major driver. As mental health issues become more recognized and addressed, the demand for effective treatments like Effexor XR increases[1].

Growing Geriatric Population

The increasing geriatric population is another significant factor, as older adults are more likely to suffer from depression and other mental health conditions[1].

Rising Healthcare Expenditure

Higher healthcare expenditure and government initiatives to improve mental health care are also boosting the market. Developed regions with well-established healthcare infrastructures, such as North America, are particularly driving this growth[1].

Research and Development Activities

Increased research and development activities, along with strategic collaborations among pharmaceutical companies, are providing new opportunities for the venlafaxine market[1].

Regional Market Performance

North America

North America dominates the venlafaxine market due to the presence of major key players, high disposable income, and a well-developed healthcare infrastructure. This region continues to be a significant market for Effexor XR[1].

Asia-Pacific

The Asia-Pacific region is expected to grow significantly during the forecast period due to increasing research and development activities and growing government support. China, in particular, has seen significant market share for Effexor XR, with the drug accounting for about 50% of the market share in terms of sales value in 2020[1][4].

Challenges and Restraints

Despite the growth potential, there are several challenges facing the venlafaxine market:

High Cost of the Drug

The high cost of Effexor XR is a significant barrier, especially in regions with lower healthcare budgets. This can limit accessibility and impact market growth[1].

Side Effects

Side effects associated with venlafaxine, such as loss of appetite, diarrhea, headache, nausea, dizziness, and seizures, can also hamper market growth. These side effects may lead to patient non-compliance and reduced prescription rates[1].

Lack of Awareness

Lack of awareness about mental health disorders and the availability of treatments like Effexor XR can further challenge market expansion, particularly in regions with limited healthcare education and resources[1].

Financial Performance and Cost Effectiveness

Market Size and Revenue

The venlafaxine market, including Effexor XR, has shown substantial revenue growth. In China, for example, the sales value of venlafaxine decreased temporarily in 2020 due to the COVID-19 pandemic but is expected to recover and grow from 2021 to 2025[4].

Cost Effectiveness Analysis

Studies have compared the cost effectiveness of venlafaxine XR with other antidepressants. For instance, a study comparing escitalopram with venlafaxine XR found that escitalopram may be associated with lower healthcare costs while maintaining similar effectiveness. This suggests that while Effexor XR is effective, it may face competition from more cost-effective alternatives[5].

Impact of COVID-19

The COVID-19 pandemic had a temporary negative impact on the venlafaxine market, particularly in regions like China where healthcare institutions faced operational challenges. However, as the pandemic is brought under control, the market is expected to rebound and continue its growth trajectory[4].

Key Players and Market Share

Effexor XR, originally developed by Wyeth (a subsidiary of Pfizer), remains a dominant player in the venlafaxine market. In China, Effexor XR accounted for about 50% of the market share in terms of sales value in 2020. Local generic versions, such as those from Chengdu Kanghong Pharmaceutical Group, also play a significant role in the market[4].

Future Outlook

The future outlook for Effexor XR is positive, driven by increasing demand for mental health treatments, advancements in healthcare infrastructure, and ongoing research and development. However, the market will need to address challenges such as high drug costs and side effects to maintain its growth momentum.

Key Takeaways

• The venlafaxine market, including Effexor XR, is expected to grow at a CAGR of 4% from 2022 to 2029.
• Drivers include increasing prevalence of mental health disorders, growing geriatric population, and rising healthcare expenditure.
• North America and Asia-Pacific are key regions driving market growth.
• High drug costs and side effects are significant challenges.
• Effexor XR dominates the market but faces competition from cost-effective alternatives.

Frequently Asked Questions

Q: What is Effexor XR used for? A: Effexor XR is used to treat major depressive disorder, generalized anxiety disorder (GAD), social anxiety disorder, and panic disorder.

Q: What are the main drivers of the venlafaxine market growth? A: The main drivers include the increasing prevalence of mental health disorders, growing geriatric population, rising healthcare expenditure, and research and development activities.

Q: Which region dominates the venlafaxine market? A: North America dominates the venlafaxine market due to the presence of major key players and well-developed healthcare infrastructure.

Q: What are the challenges facing the venlafaxine market? A: High drug costs, side effects, and lack of awareness are significant challenges facing the market.

Q: How has COVID-19 impacted the venlafaxine market? A: COVID-19 had a temporary negative impact on the market, particularly in regions like China, but the market is expected to recover as the pandemic is brought under control.

Cited Sources:

1. Data Bridge Market Research - Global Venlafaxine Market - Industry Trends and Forecast to 2029
2. FDA - Effexor XR Label
3. Biospace - Venlafaxine Hydrochloride Market Size, Share, Industry Growth ...
4. Business Wire - Research Report on China's Venlafaxine Markets, 2016-2020 ...
5. PubMed - Evaluation of the Cost Effectiveness of Escitalopram ...