Venlafaxine hydrochloride - Generic Drug Details

What are the generic sources for venlafaxine hydrochloride and what is the scope of patent protection?

Venlafaxine hydrochloride is the generic ingredient in three branded drugs marketed by Upjohn, Alembic, Anchen Pharms, Annora Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Intellipharmaceutics, Inventia Hlthcare, Macleods Pharms Ltd, Norvium Bioscience, Nostrum Pharms Llc, Orbion Pharms, Teva, Torrent, Valeant Pharms North, Wockhardt Bio Ag, Yichang Humanwell, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Alkem Labs Ltd, Appco, Ascent Pharms Inc, Cadila Pharms Ltd, Dexcel, Nostrum Labs Inc, Osmotica Pharm Us, Sun Pharm, Swiss Pharm, Unique, Zydus Pharms, Wyeth Pharms Inc, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Heritage, Pliva Hrvatska Doo, Prinston Inc, Sun Pharm Inds Inc, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in forty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-one drug master file entries for venlafaxine hydrochloride. Sixty-eight suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for venlafaxine hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	42
NDAs:	47
Drug Master File Entries:	41
Finished Product Suppliers / Packagers:	68
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	205
Patent Applications:	3,157
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for venlafaxine hydrochloride
What excipients (inactive ingredients) are in venlafaxine hydrochloride?	venlafaxine hydrochloride excipients list
DailyMed Link:	venlafaxine hydrochloride at DailyMed

Recent Clinical Trials for venlafaxine hydrochloride

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

Sponsor	Phase
Reinier de Graaf Groep	Phase 3
Shalamar Institute of Health Sciences	N/A
Dr. Inge Winter	Phase 4

See all venlafaxine hydrochloride clinical trials

Generic filers with tentative approvals for VENLAFAXINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		150MG	CAPSULE, EXTENDED RELEASE; ORAL
		75MG	CAPSULE, EXTENDED RELEASE; ORAL
		37.5MG	CAPSULE, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for venlafaxine hydrochloride

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

Medical Subject Heading (MeSH) Categories for venlafaxine hydrochloride

Antidepressive Agents, Second-Generation

Serotonin and Noradrenaline Reuptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for venlafaxine hydrochloride

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for VENLAFAXINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VENLAFAXINE HYDROCHLORIDE	Extended-release Tablets	venlafaxine hydrochloride	225 mg	022104	1	2011-01-10
VENLAFAXINE HYDROCHLORIDE	Extended-release Tablets	venlafaxine hydrochloride	37.5 mg, 75 mg and 150 mg	022104	1	2009-02-12
EFFEXOR XR	Extended-release Tablets	venlafaxine hydrochloride	37.5 mg, 75 mg and 150 mg	020699	1	2007-05-03
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 venlafaxine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Anchen Pharms	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078087-001	Mar 16, 2012		DISCN	No	No
Zydus Pharms	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	215622-001	Aug 30, 2022	AB	RX	No	No
Intellipharmaceutics	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201272-001	Nov 23, 2018	AB	RX	No	No
Yichang Humanwell	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	214654-002	Aug 6, 2021	AB	RX	No	No
Zydus Pharms Usa Inc	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	090174-001	Apr 14, 2011	AB	RX	No	No

Expired US Patents for venlafaxine hydrochloride

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
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-004	Oct 20, 1997	6,310,101
Wyeth Pharms Inc	EFFEXOR	venlafaxine hydrochloride	TABLET;ORAL	020151-006	Dec 28, 1993	6,274,171
Wyeth Pharms Inc	EFFEXOR	venlafaxine hydrochloride	TABLET;ORAL	020151-003	Dec 28, 1993	5,916,923
Wyeth Pharms Inc	EFFEXOR	venlafaxine hydrochloride	TABLET;ORAL	020151-004	Dec 28, 1993	6,274,171

Venlafaxine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Venlafaxine Hydrochloride

Introduction

Venlafaxine hydrochloride, a versatile antidepressant medication, has been a significant player in the pharmaceutical market for several years. This article delves into the market dynamics, financial trajectory, and key factors influencing the venlafaxine hydrochloride market.

Market Size and Growth

The global venlafaxine hydrochloride market has demonstrated substantial growth over recent years. As of 2023, the market size was valued at several million dollars, with a projected compound annual growth rate (CAGR) of a significant percentage from 2024 to 2031[1][3][4].

Regional Analysis

The market is segmented into five major regions: North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region contributes significantly to the overall market revenue, with the Asia Pacific region expected to register a higher growth rate due to increasing research activities and a growing patient population in countries like China, India, and Japan[1][3][4].

Application and End-Use Industries

Venlafaxine hydrochloride is widely used for treating major depressive disorders, generalized anxiety disorders, panic disorder, social phobia, and vasomotor symptoms. It also finds application in the treatment of diabetic neuropathy, migraine, and potentially attention deficit-hyperactivity disorder (ADHD) and post-traumatic stress disorder (PTSD)[4].

Market Drivers

Several factors drive the growth of the venlafaxine hydrochloride market:

• Increasing Prevalence of Mental Health Disorders: The rising incidence of depression, anxiety, and other mental health conditions globally is a significant driver.
• Effective Pharmacologic Benefits: Venlafaxine's early onset of action, dose flexibility, and broad range of activity make it a preferred choice among healthcare providers[2][4].
• Cost-Effectiveness: Studies have shown that venlafaxine can result in cost savings compared to other antidepressants, such as fluoxetine, due to its improved tolerability and efficacy[2].

Market Restraints

Despite its benefits, the market faces several challenges:

• Side Effects: Venlafaxine is associated with serious side effects, including suicidal symptoms, bipolar disorder, discontinuation syndrome, and cardiovascular events[5].
• Withdrawal Symptoms: The medication has a high risk of withdrawal symptoms if stopped abruptly, which can be severe and resemble a stroke[5].

Competitive Landscape

The venlafaxine hydrochloride market is competitive, with key players such as Teva and Pfizer focusing on strengthening their product portfolios and expanding their business globally. These companies employ strategies like mergers, acquisitions, product launches, and brand promotions to maintain their market position[3][4].

Financial Performance

The financial performance of the venlafaxine hydrochloride market is robust, with significant revenue generated from various segments:

• Revenue Share: The market is segmented based on type, application, and region, with each segment contributing to the overall revenue share. For instance, the 37.5mg segment of venlafaxine hydrochloride extended-release capsules accounted for a noticeable share in 2023 and is projected to experience significant growth[3].
• Cost Savings: Venlafaxine has been shown to offer cost savings in the treatment of depression, with an estimated 11.3% cost savings compared to fluoxetine in one study[2].

Technological and Regulatory Trends

The market is influenced by various technological and regulatory trends:

• Patent Analysis: The expiration of patents for branded versions like Effexor has led to the rise of generic venlafaxine, which is significantly cheaper and equally effective[5].
• COVID-19 Impact: The COVID-19 pandemic has accelerated the demand for mental health treatments, including venlafaxine hydrochloride, due to increased stress and anxiety levels globally[1][3].

Market Attractiveness

The venlafaxine hydrochloride market remains attractive due to several factors:

• Growing Demand: The increasing prevalence of mental health disorders and the effectiveness of venlafaxine in treating these conditions make it a lucrative market.
• Competitive Strategies: Companies are continuously innovating and expanding their product lines, which keeps the market dynamic and competitive[1][3][4].

Consumer Behavior Analysis

Consumer behavior plays a crucial role in the venlafaxine hydrochloride market:

• Patient Preferences: Patients often prefer generic versions due to their lower cost without compromising on efficacy. However, the risk of serious side effects and withdrawal symptoms necessitates careful consideration and medical supervision[5].
• Healthcare Provider Influence: Healthcare providers' recommendations significantly influence the choice of medication, with many opting for venlafaxine due to its pharmacologic benefits and cost-effectiveness[2][4].

Future Prospects

The future prospects of the venlafaxine hydrochloride market are promising:

• Forecasted Growth: The market is expected to grow significantly from 2025 to 2031, driven by increasing demand and technological advancements[1][3][4].
• Emerging Markets: The Asia Pacific region is expected to be a key growth driver due to its large patient population and increasing healthcare expenditure[1][3][4].

Key Takeaways

• The venlafaxine hydrochloride market is growing significantly due to the increasing prevalence of mental health disorders.
• The medication offers several pharmacologic benefits and is cost-effective compared to other antidepressants.
• Despite its benefits, the market faces challenges related to side effects and withdrawal symptoms.
• The competitive landscape is dynamic, with key players focusing on innovation and expansion.
• The future prospects of the market are promising, especially in emerging regions like the Asia Pacific.

FAQs

What are the primary uses of venlafaxine hydrochloride?

Venlafaxine hydrochloride is primarily used to treat major depressive disorders, generalized anxiety disorders, panic disorder, social phobia, and vasomotor symptoms. It is also used for treating diabetic neuropathy, migraine, and potentially ADHD and PTSD[4].

What are the key drivers of the venlafaxine hydrochloride market?

The key drivers include the increasing prevalence of mental health disorders, the effective pharmacologic benefits of venlafaxine, and its cost-effectiveness compared to other antidepressants[2][4].

What are the major side effects associated with venlafaxine hydrochloride?

Major side effects include suicidal symptoms, bipolar disorder, discontinuation syndrome, and cardiovascular events. The medication also has a high risk of withdrawal symptoms if stopped abruptly[5].

How does the generic version of venlafaxine compare to the branded version?

The generic version of venlafaxine is equally effective as the branded version (Effexor) but is significantly cheaper. There is no added benefit to taking the brand-name medication over the generic version[5].

What regions are expected to drive the growth of the venlafaxine hydrochloride market?

The Asia Pacific region is expected to be a key growth driver due to its large patient population and increasing healthcare expenditure. Other regions, including North America, Europe, Latin America, and Middle East & Africa, also contribute significantly to the market growth[1][3][4].

Sources

1. Cognitive Market Research: Global Venlafaxine Hydrochloride Market Report 2024 Edition.
2. PubMed: Cost-effectiveness of venlafaxine for the treatment of major depression.
3. Cognitive Market Research: Global Venlafaxine Hydrochloride Extended Release Capsule Market Report 2024.
4. Reports and Data: Venlafaxine Hydrochloride Market Share & Analysis, 2020-2027.
5. Illuminate Labs: Venlafaxine Review | Depression & Anxiety Treatment?