DESVENLAFAXINE - Generic Drug Details

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

Desvenlafaxine is the generic ingredient in four branded drugs marketed by Alembic Pharms Ltd, Osmotica Pharm Corp, Sun Pharm, Teva Pharms Usa, Actavis Labs Fl, Alembic, Hikma, Intellipharmaceutics, Lupin Ltd, Norvium Bioscience, Rubicon, Yichang Humanwell, Zydus Pharms, and Pf Prism Cv, and is included in fifteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for desvenlafaxine. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for DESVENLAFAXINE

US Patents:	1
Tradenames:	4
Applicants:	14
NDAs:	15
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	71
Patent Applications:	4,438
Drug Prices:	Drug price trends for DESVENLAFAXINE
What excipients (inactive ingredients) are in DESVENLAFAXINE?	DESVENLAFAXINE excipients list
DailyMed Link:	DESVENLAFAXINE at DailyMed

See drug prices for DESVENLAFAXINE

Recent Clinical Trials for DESVENLAFAXINE

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

Sponsor	Phase
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude	Phase 2
Sage Therapeutics	Phase 3
H. Lundbeck A/S	Phase 4

See all DESVENLAFAXINE clinical trials

Generic filers with tentative approvals for DESVENLAFAXINE

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET, EXTENDED RELEASE;ORAL
		50MG	TABLET, 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 DESVENLAFAXINE

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

Anatomical Therapeutic Chemical (ATC) Classes for DESVENLAFAXINE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for DESVENLAFAXINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204082-002	Aug 28, 2017	AB	RX	No	No
Alembic	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204003-002	Jun 29, 2015	AB	RX	No	No
Osmotica Pharm Corp	KHEDEZLA	desvenlafaxine	TABLET, EXTENDED RELEASE;ORAL	204683-002	Jul 10, 2013		DISCN	No	No
Lupin Ltd	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204172-001	Jun 29, 2015	AB	RX	No	No
Alembic	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204003-001	Jun 29, 2015	AB	RX	No	No
Rubicon	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204028-001	Jun 29, 2015	AB	RX	No	No

DESVENLAFAXINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Desvenlafaxine

Introduction

Desvenlafaxine, a selective serotonin-norepinephrine reuptake inhibitor (SNRI), has been a significant player in the treatment of major depressive disorder (MDD) and other mental health conditions. Here, we delve into the market dynamics and financial trajectory of desvenlafaxine, highlighting key factors driving its growth and future projections.

Market Size and Projections

The desvenlafaxine market has been experiencing robust growth. As of 2023, the market size was valued at USD 100 billion and is projected to reach USD 140.71 billion by 2031, growing at a compound annual growth rate (CAGR) of 5% from 2024 to 2031[1].

Segmentation and Application

The market is segmented based on type (tablets, extended-release tablets, capsules, injectable) and application (major depressive disorder treatment, anxiety disorder treatment, fibromyalgia management, neuropathic pain management, menopausal symptom relief). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1].

Drivers of Market Growth

Several factors are driving the growth of the desvenlafaxine market:

Increasing Prevalence of Mental Health Disorders

The rising prevalence of anxiety and depression globally is a significant driver. As mental health awareness increases, the demand for effective therapies like desvenlafaxine is also on the rise[1].

Pharmaceutical R&D and Innovations

Advancements in pharmaceutical research and development are broadening the range of available treatments. New formulations and expanded indications are contributing to market growth. For instance, current clinical studies are investigating new indications, including anxiety disorders[1].

Patient Compliance and Efficacy

The extended-release formulation of desvenlafaxine improves patient compliance, which is a crucial factor in its market success. The drug's mechanism of action, targeting both serotonin and norepinephrine, makes it an attractive option for healthcare professionals seeking comprehensive treatment for depression[1].

Economic and Clinical Value

Studies have shown that desvenlafaxine can be a cost-effective option compared to other antidepressants. For example, in Spain, initiating second-line treatment with desvenlafaxine resulted in lower drug and events management costs, leading to an overall cost reduction of €108 for the National Health System[2].

Regional Market Trends

The global desvenlafaxine market is diverse, with varying trends across different regions:

North America and Europe

These regions are expected to maintain significant market shares due to high healthcare spending and advanced healthcare infrastructure. The presence of major pharmaceutical companies and ongoing research activities also contribute to the market growth in these regions[4].

Asia-Pacific

This region is witnessing rapid growth due to increasing healthcare access and a growing awareness of mental health issues. Countries like India and China are becoming key markets for desvenlafaxine, driven by their large populations and improving economic conditions[4].

Competitive Landscape

The desvenlafaxine market is competitive, with several key players focusing on strategy building and product portfolio expansion. Companies like Adroit PharmaChem and Teva are actively involved in innovating new formulations and increasing product availability in growing markets[4].

Sales Growth and Market Share

Desvenlafaxine has shown significant sales growth compared to other antidepressants. In Brazil, for example, desvenlafaxine had a growth rate of 285.2% between 2014 and 2019, making it one of the fastest-growing antidepressants in the market[3].

Pharmacokinetics and Clinical Efficacy

Desvenlafaxine's pharmacokinetics are linear and dose-proportional, with a half-life that supports its efficacy in treating MDD. Clinical trials have established its effectiveness in improving depressive symptoms and overall patient improvement, with minimal drug-drug interactions due to its unique metabolism[5].

Challenges and Restraints

Despite the growth, the market faces some challenges:

Side Effects and Tolerability

While desvenlafaxine has a tolerability profile comparable to other SNRIs, common adverse effects such as nausea and dizziness can impact patient compliance. Starting with lower doses or every-other-day dosing can help mitigate these side effects[5].

Regulatory and Economic Factors

Healthcare costs and regulatory environments can influence market uptake. However, the cost-effectiveness of desvenlafaxine, as demonstrated in various economic evaluations, helps in navigating these challenges[2].

Future Prospects

The desvenlafaxine market is expected to continue its upward trajectory driven by:

Expanding Indications

Ongoing clinical studies exploring new indications, such as anxiety disorders, will further broaden the market for desvenlafaxine[1].

Increasing Access to Mental Health Services

Globally expanding access to mental health services and rising healthcare costs are driving the demand for effective treatments like desvenlafaxine[1].

Innovations in Formulations

Pharmaceutical companies' efforts to create new formulations and increase product availability in growing areas will continue to drive market growth[1].

Key Takeaways

• The desvenlafaxine market is projected to grow from USD 100 billion in 2023 to USD 140.71 billion by 2031.
• The market is driven by increasing mental health awareness, pharmaceutical R&D, and the drug's efficacy and cost-effectiveness.
• Regional trends vary, with North America and Europe maintaining significant shares and the Asia-Pacific region showing rapid growth.
• The competitive landscape is marked by key players innovating and expanding their product portfolios.
• Despite challenges like side effects, the market is expected to continue growing due to expanding indications and increasing access to mental health services.

FAQs

What is the projected market size of desvenlafaxine by 2031?

The desvenlafaxine market is expected to reach USD 140.71 billion by 2031, growing at a CAGR of 5% from 2024 to 2031[1].

What are the main drivers of the desvenlafaxine market growth?

The main drivers include the increasing prevalence of mental health disorders, advancements in pharmaceutical R&D, improved patient compliance due to extended-release formulations, and the drug's efficacy and cost-effectiveness[1].

Which regions are expected to contribute significantly to the desvenlafaxine market growth?

North America and Europe are expected to maintain significant market shares, while the Asia-Pacific region is witnessing rapid growth due to increasing healthcare access and awareness of mental health issues[4].

What are the common side effects of desvenlafaxine?

Common adverse effects include nausea and dizziness, which can be mitigated by starting with lower doses or every-other-day dosing[5].

How does desvenlafaxine compare to other antidepressants in terms of cost-effectiveness?

Desvenlafaxine has been shown to be a cost-effective option compared to other antidepressants, such as duloxetine and venlafaxine, particularly in reducing healthcare costs and improving patient outcomes[2].

Sources

1. Market Research Intellect: Desvenlafaxine Succinate Market Size and Projections.
2. PubMed: Economic evaluation of desvenlafaxine in the treatment of major depressive disorder.
3. Frontiers in Pharmacology: Trends in Brazilian market of antidepressants: A five-year dataset.
4. Cognitive Market Research: Desvenlafaxine Market Report 2024 (Global Edition).
5. Current Psychiatry: Desvenlafaxine for depression.