Vilazodone hydrochloride - Generic Drug Details

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

Vilazodone hydrochloride is the generic ingredient in two branded drugs marketed by Abbvie, Accord Hlthcare, Alembic, Apotex, Invagen Pharms, and Teva Pharms Usa, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for vilazodone hydrochloride. Fourteen suppliers are listed for this compound.

Summary for vilazodone hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	27
Patent Applications:	162
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for vilazodone hydrochloride
What excipients (inactive ingredients) are in vilazodone hydrochloride?	vilazodone hydrochloride excipients list
DailyMed Link:	vilazodone hydrochloride at DailyMed

Recent Clinical Trials for vilazodone hydrochloride

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

Sponsor	Phase
Risk Benefit Statistics LLC
National Alliance on Mental Illness New Mexico
Montana State University

See all vilazodone hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for vilazodone hydrochloride

Antidepressive Agents

Serotonin 5-HT1 Receptor Agonists

Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for vilazodone hydrochloride

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for VILAZODONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIIBRYD	Tablets	vilazodone hydrochloride	10 mg, 20 mg, and 40 mg	022567	5	2015-01-21

US Patents and Regulatory Information for vilazodone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	VILAZODONE HYDROCHLORIDE	vilazodone hydrochloride	TABLET;ORAL	208209-003	Apr 27, 2021	AB	RX	No	No
Invagen Pharms	VILAZODONE HYDROCHLORIDE	vilazodone hydrochloride	TABLET;ORAL	208200-001	Apr 7, 2021	AB	RX	No	No
Invagen Pharms	VILAZODONE HYDROCHLORIDE	vilazodone hydrochloride	TABLET;ORAL	208200-003	Dec 6, 2022	AB	RX	No	No
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-002	Jan 21, 2011	AB	RX	Yes	No
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-003	Jan 21, 2011	AB	RX	Yes	No
Apotex	VILAZODONE HYDROCHLORIDE	vilazodone hydrochloride	TABLET;ORAL	208228-003	Jul 7, 2023	AB	RX	No	No

Expired US Patents for vilazodone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-001	Jan 21, 2011
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-002	Jan 21, 2011
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-003	Jan 21, 2011

Vilazodone hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vilazodone Hydrochloride (Viibryd)

Introduction to Vilazodone Hydrochloride

Vilazodone hydrochloride, marketed as Viibryd, is an antidepressant that combines the mechanisms of a selective serotonin reuptake inhibitor (SSRI) and a 5-HT1A receptor partial agonist. This unique pharmacological profile makes it an attractive option for treating major depressive disorder (MDD) and potentially other mental health conditions[3][5].

Market Size and Growth Projections

The Viibryd market is anticipated to experience significant growth over the forecast period from 2024 to 2031. The market is projected to grow at a compound annual growth rate (CAGR) of approximately 5.3% to 5.7%, driven by increasing prevalence of mental health disorders, rising awareness about treatment options, and ongoing destigmatization of mental health issues[3][4].

Segmentation of the Viibryd Market

The Viibryd market is segmented based on several key factors:

By Product

• The market is segmented into 10 mg, 20 mg, and 40 mg doses. The 10 mg segment has been particularly notable, accounting for a significant share of the global market and expected to experience significant growth[1][3].

By Application

• The primary application is for the treatment of major depressive disorder (MDD), but there is also potential for use in anxiety and other mood disorders[3][4].

By Geography

• North America currently dominates the market with a share of around 45%, followed by Europe with approximately 30%, and the Asia-Pacific region with about 15%. China's market share stands at around 10%[3].

Key Drivers of Market Growth

Several factors are driving the growth of the Viibryd market:

Increasing Prevalence of Mental Health Disorders

• The rising incidence of depression and other mental health conditions is a major driver. As more people seek treatment, the demand for effective antidepressants like Viibryd increases[3].

Improving Healthcare Access and Awareness

• Enhanced healthcare infrastructure and growing awareness about mental health treatments are contributing to the market's expansion. The ongoing destigmatization of mental health issues also encourages more patients to seek medical help[3].

Innovations in Drug Formulations

• Advances in drug formulations and delivery mechanisms are improving patient compliance and expanding the market. New formulations and delivery systems can enhance the efficacy and tolerability of Viibryd[3].

Financial Metrics and Key Players

Revenue and Market Share

• Major players such as Allergan plc (AbbVie Inc.), Actavis Generics (Teva), and Clinical Data, Inc. are significant contributors to the market. AbbVie reported total revenue of approximately $58 billion in 2022, with a robust segment from its neuroscience products. Teva Pharmaceuticals generated around $15 billion in revenue, highlighting its strong presence in generics and specialty pharmaceuticals[3].

Profitability Analysis

• The financial trajectory for Viibryd manufacturers is positive, with expected growth in total income, gross profit, and net profit over the forecast period. The market data indicates a gross margin and net margin that are favorable, suggesting a profitable venture for manufacturers[2].

Challenges and Restraints

Despite the positive growth trajectory, there are several challenges and restraints to consider:

Regulatory Procedures and Approvals

• Setting up a manufacturing plant for Viibryd involves navigating complex regulatory procedures and obtaining necessary approvals. This can be a significant hurdle for new entrants in the market[2].

Capital and Operational Expenditures

• The capital expenditure (CapEx) and operational expenditure (OpEx) for setting up a Viibryd manufacturing plant are substantial. Detailed financial analysis, including income projections, taxation, depreciation, and liquidity analysis, is essential to ensure the viability of such projects[2].

Safety and Efficacy Concerns

• Ensuring the safety and efficacy of Viibryd is crucial. Post-marketing commitments, such as monitoring blood pressure and pulse rate in patients with hypertension or pre-existing heart disease, are necessary to further characterize the pharmacokinetic profile of the drug[5].

Opportunities for Manufacturers

There are several opportunities for Viibryd manufacturers:

Expanding Indications

• Potential use in anxiety and other mood disorders could significantly expand the market for Viibryd. Ongoing clinical studies and research into new indications are key opportunities for growth[3].

Partnerships and Collaborations

• Collaborations with other pharmaceutical companies for clinical trials and development can influence market dynamics positively. Partnerships can accelerate the development of new therapies and enhance market penetration[3].

Geographical Expansion

• The APAC region and other emerging markets offer significant growth potential due to evolving healthcare infrastructure and rising mental health awareness. Expanding into these regions can help manufacturers tap into new markets[3].

Key Takeaways

• The Viibryd market is expected to grow at a CAGR of 5.3% to 5.7% from 2024 to 2031.
• The market is driven by increasing prevalence of mental health disorders, improving healthcare access, and innovations in drug formulations.
• Major players like AbbVie and Teva dominate the market, with significant revenue contributions from neuroscience products.
• Regulatory procedures, capital and operational expenditures, and safety concerns are key challenges.
• Expanding indications, partnerships, and geographical expansion offer significant opportunities for growth.

FAQs

Q: What is the primary use of Vilazodone Hydrochloride (Viibryd)?

• Vilazodone Hydrochloride (Viibryd) is primarily used for the treatment of major depressive disorder (MDD).

Q: Which segment of the Viibryd market is expected to experience significant growth?

• The 10 mg segment of the Viibryd market is expected to experience significant growth.

Q: What is the projected CAGR for the Viibryd market from 2024 to 2031?

• The Viibryd market is projected to grow at a CAGR of approximately 5.3% to 5.7%.

Q: Who are the major players in the Viibryd market?

• Major players include Allergan plc (AbbVie Inc.), Actavis Generics (Teva), and Clinical Data, Inc.

Q: What are the key drivers of the Viibryd market growth?

• Key drivers include increasing prevalence of mental health disorders, improving healthcare access, and innovations in drug formulations.

Cited Sources

1. Cognitivemarketresearch.com: Viibryd Vilazodone Market Report 2024 (Global Edition)
2. IMARC Group: Vilazodone (Viibryd) Manufacturing Plant Project Report 2024
3. GitHub: Viibryd (Vilazodone) Market Size Focuses on Market Dynamics, In-Depth Analysis and Future Projections of its Market Forecasted for Period from 2024 to 2031
4. MarketResearchIntellect.com: Global Viibryd Vilazodone Market Size And Forcast
5. FDA.gov: NDA 022567 Vilazodone Hydrochloride[5]