EFFEXOR Drug Patent Profile

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

Effexor is a drug marketed by Wyeth Pharms Inc and Upjohn and is included in two NDAs.

The generic ingredient in EFFEXOR 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

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

Summary for EFFEXOR

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	224
Clinical Trials:	63
Patent Applications:	2,197
Drug Prices:	Drug price information for EFFEXOR
Drug Sales Revenues:	Drug sales revenues for EFFEXOR
What excipients (inactive ingredients) are in EFFEXOR?	EFFEXOR excipients list
DailyMed Link:	EFFEXOR at DailyMed

See drug prices for EFFEXOR

Recent Clinical Trials for EFFEXOR

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 clinical trials

Paragraph IV (Patent) Challenges for EFFEXOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EFFEXOR	Tablets	venlafaxine hydrochloride	25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg	020151	1	2005-11-03

US Patents and Regulatory Information for EFFEXOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms Inc	EFFEXOR	venlafaxine hydrochloride	TABLET;ORAL	020151-001	Dec 28, 1993		DISCN	Yes	No
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-001	Oct 20, 1997	AB	RX	Yes	No
Wyeth Pharms Inc	EFFEXOR	venlafaxine hydrochloride	TABLET;ORAL	020151-003	Dec 28, 1993		DISCN	Yes	No
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-002	Oct 20, 1997	AB	RX	Yes	No
Wyeth Pharms Inc	EFFEXOR	venlafaxine hydrochloride	TABLET;ORAL	020151-002	Dec 28, 1993		DISCN	Yes	No

Expired US Patents for EFFEXOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	EFFEXOR	venlafaxine hydrochloride	TABLET;ORAL	020151-003	Dec 28, 1993	4,535,186*PED
Wyeth Pharms Inc	EFFEXOR	venlafaxine hydrochloride	TABLET;ORAL	020151-005	Dec 28, 1993	5,916,923
Wyeth Pharms Inc	EFFEXOR	venlafaxine hydrochloride	TABLET;ORAL	020151-004	Dec 28, 1993	5,916,923
Wyeth Pharms Inc	EFFEXOR	venlafaxine hydrochloride	TABLET;ORAL	020151-002	Dec 28, 1993	5,916,923
Wyeth Pharms Inc	EFFEXOR	venlafaxine hydrochloride	TABLET;ORAL	020151-006	Dec 28, 1993	6,274,171

International Patents for EFFEXOR

See the table below for patents covering EFFEXOR 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
Austria	237320

Supplementary Protection Certificates for EFFEXOR

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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: EFFEXOR

Introduction to EFFEXOR

EFFEXOR, known generically as venlafaxine, is a serotonin-norepinephrine reuptake inhibitor (SNRI) used primarily to treat depression, anxiety disorders, and some other mental health conditions. It is available in various forms, including extended-release capsules and tablets.

Market Growth and Forecast

The venlafaxine market, which includes EFFEXOR, is anticipated to experience significant growth over the forecast period of 2022-2029. 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 for the expansion of the venlafaxine market[1].
• Growing Geriatric Population: An increasing geriatric population, which is more prone to mental health issues, is another significant factor[1].
• Rising Healthcare Expenditure: Increased healthcare spending and government initiatives to improve mental health care are also contributing to market growth[1].
• Research and Development: The rise in research and development activities and strategic collaborations among pharmaceutical companies will provide beneficial opportunities for the venlafaxine market[1].

Regional Market Dynamics

North America

North America dominates the venlafaxine market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure in this region[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. In China, for example, EFFEXOR XR holds a major market share, accounting for about 50% of the market share in terms of sales value in 2020[3].

China's Market

In China, the venlafaxine market experienced a temporary decline in sales value in 2020 due to the impact of COVID-19, but it is expected to see growth from 2021 to 2025 as the pandemic is brought under control. The rising stress of Chinese residents' lives, driven by economic development, urbanization, and changing interpersonal relationships, is expected to increase the demand for antidepressants like venlafaxine[3].

Financial Performance

Viatris Financials

Viatris, the company behind EFFEXOR, reported strong financial performance in recent years. For instance, in 2022, Viatris reported net sales of $4,331.3 million, with EFFEXOR contributing significantly to these revenues. The adjusted gross profit and adjusted net earnings also showed positive trends, indicating the financial health of the product[2].

Revenue Breakdown

• Net Sales: The net sales for Viatris, which includes EFFEXOR, have shown an upward trend. In 2022, the net sales were $4,331.3 million, up from $3,867.1 million in the previous year[2].
• Adjusted Gross Profit: The adjusted gross profit for Viatris was $2,458.7 million in 2022, reflecting a stable margin of around 56.6%[2].
• Adjusted Net Earnings: The adjusted net earnings for Viatris were $912.2 million in 2022, indicating a healthy financial trajectory for the company and its products, including EFFEXOR[2].

Challenges and Restraints

Despite the positive market dynamics, there are several challenges that could impact the growth of the venlafaxine market:

• High Cost of the Drug: The high cost of venlafaxine is a significant restraint, making it less accessible to some patients[1].
• Side Effects: Side effects associated with venlafaxine, such as loss of appetite, diarrhea, headache, nausea, dizziness, and seizures, can also hamper market growth[1].
• Lack of Awareness: Limited awareness about mental health and the availability of treatments like venlafaxine can further challenge market expansion[1].

Competitive Landscape

The venlafaxine market is competitive, with several key players:

• Pfizer: Originally developed by Pfizer under the trade name EFFEXOR XR, this brand still holds a significant market share, especially in China[3].
• Generic Manufacturers: Companies like Chengdu Kanghong Pharmaceutical Group, Beijing Winsunny Pharmaceutical Co., Ltd, and others offer generic versions of venlafaxine, which compete with branded products[3].
• Other Players: Other companies such as Sun Pharmaceutical Industries, Mesha Pharma, and Taj API also play a role in the global venlafaxine market[4].

Sales by Dosage Form

The sales of venlafaxine are segmented by dosage form, including extended-release capsules, extended-release tablets, capsules, and other forms. In China, for example, the sales of venlafaxine by dosage form showed varied market shares, with extended-release capsules being a popular form[3].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the venlafaxine market, particularly in China. The pandemic disrupted healthcare services, leading to a decrease in sales value in 2020. However, as the pandemic is brought under control, the market is expected to recover and grow[3].

Future Prospects

The future prospects for the venlafaxine market, including EFFEXOR, look promising:

• Growing Demand: The increasing prevalence of mental health disorders and the growing awareness about these conditions are expected to drive demand for venlafaxine[1].
• Research and Development: Continued research and development activities, along with strategic collaborations, will provide opportunities for market growth[1].
• Expanding Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in developing regions, will also support market expansion[4].

Key Takeaways

• The global venlafaxine market, including EFFEXOR, is expected to grow at a CAGR of 4% from 2022 to 2029.
• North America and the Asia-Pacific region are key markets, with North America dominating due to its well-developed healthcare infrastructure.
• The market faces challenges such as high drug costs and side effects, but is driven by increasing prevalence of mental health disorders and growing healthcare expenditure.
• The COVID-19 pandemic had a temporary negative impact, but the market is expected to recover and grow as the pandemic is controlled.
• The competitive landscape includes both branded and generic manufacturers, with Pfizer’s EFFEXOR XR holding a significant market share.

FAQs

1. What is the primary use of EFFEXOR (venlafaxine)?

EFFEXOR (venlafaxine) is primarily used to treat depression, anxiety disorders, and social anxiety disorder.

2. What is the expected growth rate of the global venlafaxine market?

The global venlafaxine market is expected to grow at a CAGR of 4% from 2022 to 2029[1].

3. Which region dominates the venlafaxine market?

North America dominates the venlafaxine market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure[1].

4. How did the COVID-19 pandemic impact the venlafaxine market in China?

The COVID-19 pandemic led to a decrease in sales value of venlafaxine in China in 2020 due to disruptions in healthcare services, but the market is expected to recover and grow as the pandemic is brought under control[3].

5. What are the main challenges facing the venlafaxine market?

The main challenges include the high cost of the drug, side effects associated with venlafaxine, and lack of awareness about mental health and available treatments[1].

Sources:

1. Data Bridge Market Research - Global Venlafaxine Market - Industry Trends and Forecast to 2029.
2. Viatris - Viatris Reports Strong Fourth Quarter and Full Year 2022 Financial Results.
3. ResearchAndMarkets.com - Research Report on China's Venlafaxine Markets, 2016-2020, 2021-2025.
4. Reports and Data - Venlafaxine Hydrochloride Market Size, Share, Industry Growth, Trend, Business Opportunities, Challenges, Drivers and Restraint Research Report by 2027.