VIIBRYD Drug Patent Profile

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

Viibryd is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in VIIBRYD is vilazodone hydrochloride. There are fourteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the vilazodone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Viibryd

A generic version of VIIBRYD was approved as vilazodone hydrochloride by TEVA PHARMS USA on September 30^th, 2019.

Summary for VIIBRYD

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	16
Patent Applications:	501
Drug Prices:	Drug price information for VIIBRYD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIIBRYD
What excipients (inactive ingredients) are in VIIBRYD?	VIIBRYD excipients list
DailyMed Link:	VIIBRYD at DailyMed

See drug prices for VIIBRYD

See drug sales revenues for VIIBRYD

Recent Clinical Trials for VIIBRYD

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

Sponsor	Phase
Forest Laboratories	Phase 1
New York State Psychiatric Institute	Phase 4
Forest Laboratories	Phase 3

See all VIIBRYD clinical trials

Paragraph IV (Patent) Challenges for VIIBRYD

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 VIIBRYD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-001	Jan 21, 2011	AB	RX	Yes	Yes
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

Expired US Patents for VIIBRYD

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

International Patents for VIIBRYD

See the table below for patents covering VIIBRYD around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5411734
Russian Federation	2004100824
Denmark	0648767
Slovakia	162004	Polymorphic forms of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2- carbamoyl-benzofuran-5-yl)piperazine hydrochloride
Hungary	9402806
Slovakia	281793

VIIBRYD Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VIIBRYD (Vilazodone)

Introduction to VIIBRYD (Vilazodone)

VIIBRYD, marketed under the generic name vilazodone, is a significant medication in the treatment of Major Depressive Disorder (MDD). It is classified as a serotonin reuptake inhibitor and partial serotonin receptor agonist (SSRI/5-HT1A), offering a dual approach to alleviate depressive symptoms by enhancing serotonin levels in the brain and activating specific serotonin receptors[3].

Market Size and Growth

The global VIIBRYD market has shown steady growth, driven by several key factors. As of 2022, the global market size was estimated to be in the millions, with a projected compound annual growth rate (CAGR) over the forecast period until 2028. The market is expected to readjust to a significant size by 2028, reflecting a CAGR during the post-COVID-19 period[1].

Regional Market Analysis

• North America: The region, particularly the US, holds a substantial share of the global VIIBRYD market. In 2021, the US market size was valued at millions of dollars, with a significant proportion of the global market share[1].
• Europe: Europe is another major market, with Germany, France, the UK, Italy, and Russia being key countries. The European market is projected to grow at a notable CAGR over the forecast period[1].
• Asia-Pacific: Countries like Japan, South Korea, and Southeast Asia are emerging as significant markets, with CAGRs of %%, %%, and %% respectively for the next six-year period[1].

Financial Performance

Revenue and Sales

VIIBRYD has consistently shown positive financial performance. For instance, in the fourth quarter of 2018, VIIBRYD/FETZIMA net revenues were $95.5 million, an increase of 7.3% from the prior year quarter. By the fourth quarter of 2019, this figure had increased to $114.2 million, representing a 19.6% increase from the prior year quarter[2][5].

Key Manufacturers and Market Share

The global VIIBRYD market is dominated by a few key manufacturers, including Allergan plc (now part of AbbVie Inc.), Actavis Generics (Teva), and Clinical Data, Inc. In 2021, the top five players held a significant share of the market revenue[1].

Drivers of Market Growth

Rising Prevalence of MDD

The increasing prevalence of Major Depressive Disorder (MDD) is a primary driver of the VIIBRYD market. As mental health stigma diminishes, more individuals are seeking treatment for depression, leading to higher demand for effective medications like VIIBRYD[3].

Personalized Medicine

The trend towards personalized medicine is another significant factor. Healthcare providers are increasingly tailoring treatment plans to meet the specific needs of patients, which has led to a greater adoption of VIIBRYD due to its unique mechanism of action and favorable side-effect profile[3].

Expansion of Telemedicine

The expansion of telemedicine and online mental health services has made it easier for individuals to access VIIBRYD prescriptions and consultations, especially in remote or underserved areas. This increased accessibility has contributed to the market's growth[3].

Healthcare Policies and Insurance Coverage

Improved access to mental health services and medications, including VIIBRYD, due to insurance reforms and mental health parity laws, has increased affordability and treatment accessibility. This has been a crucial factor in driving the market forward[3].

Competitive Landscape

The competitive landscape of the VIIBRYD market is characterized by a few dominant players. Allergan plc, now part of AbbVie Inc., is one of the leading manufacturers, and the company's financial reports reflect the drug's significant contribution to their revenue. For example, in 2019, the net revenues from VIIBRYD/FETZIMA were $114.2 million, indicating strong market performance[5].

Financial Metrics and Performance

Revenue and Net Income

Allergan's financial reports show that VIIBRYD has been a profitable asset. In 2018, the total net revenues for Allergan were $15,787.4 million, with VIIBRYD contributing a notable portion. By 2019, total net revenues had increased to $16,088.9 million, reflecting a 1.9% growth[2][5].

Operating Income and EBITDA

The non-GAAP operating income and adjusted EBITDA for Allergan also indicate the financial health of the VIIBRYD segment. In 2019, the non-GAAP operating income was $2,079.3 million, and the non-GAAP adjusted EBITDA was $2,205.8 million, showing an increase from the previous year[5].

Challenges and Opportunities

Regulatory Environment

The regulatory environment plays a crucial role in the VIIBRYD market. Manufacturers must comply with stringent regulatory procedures and obtain necessary approvals, which can be both a challenge and an opportunity for growth once navigated successfully[3].

Market Competition

The antidepressant market is highly competitive, with several drugs available. However, VIIBRYD's unique mechanism of action and favorable side-effect profile present opportunities for market differentiation and growth[3].

Future Outlook

The future outlook for the VIIBRYD market is promising, driven by the increasing awareness of mental health, the trend towards personalized medicine, and the expansion of telemedicine services. Here are some key points to consider:

• Market Growth: The global VIIBRYD market is expected to continue growing, driven by the rising prevalence of MDD and improved access to mental health services.
• Regional Expansion: Emerging markets in Asia-Pacific and other regions are expected to contribute significantly to the market's growth.
• Financial Performance: With continued strong financial performance, VIIBRYD is likely to remain a valuable asset for its manufacturers.

Key Takeaways

• Market Size and Growth: The global VIIBRYD market is projected to grow significantly over the forecast period, driven by increasing demand and improved access to mental health services.
• Regional Dynamics: The US and Europe are major markets, with Asia-Pacific emerging as a significant contributor.
• Financial Performance: VIIBRYD has shown strong financial performance, contributing significantly to the revenue of its manufacturers.
• Drivers of Growth: The market is driven by the rising prevalence of MDD, personalized medicine, telemedicine expansion, and favorable healthcare policies.
• Competitive Landscape: The market is dominated by a few key manufacturers, with Allergan plc (now part of AbbVie Inc.) being a leading player.

FAQs

What is VIIBRYD (Vilazodone), and how does it work?

VIIBRYD (Vilazodone) is a medication classified as a serotonin reuptake inhibitor and partial serotonin receptor agonist (SSRI/5-HT1A), primarily prescribed to manage Major Depressive Disorder (MDD). It works by enhancing serotonin levels in the brain and activating specific serotonin receptors.

What are the key drivers of the VIIBRYD market?

The key drivers include the rising prevalence of Major Depressive Disorder (MDD), the trend towards personalized medicine, the expansion of telemedicine services, and improved healthcare policies and insurance coverage.

Who are the major manufacturers of VIIBRYD?

The major manufacturers include Allergan plc (now part of AbbVie Inc.), Actavis Generics (Teva), and Clinical Data, Inc.

What is the projected growth rate of the VIIBRYD market?

The global VIIBRYD market is projected to grow at a significant CAGR over the forecast period until 2028, driven by various market dynamics.

How has the COVID-19 pandemic affected the VIIBRYD market?

The COVID-19 pandemic has had a mixed impact, with some market contraction in the initial phases but a readjusted growth trajectory in the post-pandemic period.

What are the unique advantages of VIIBRYD compared to other antidepressants?

VIIBRYD has a favorable side-effect profile with fewer sexual side effects and weight gain compared to some other antidepressants. It also addresses both depressive and anxiety symptoms, making it a valuable option for individuals with comorbid anxiety disorders.

Sources

1. Global Viibryd (Vilazodone) Market Insights, Forecast to 2028. Valuates Reports.
2. Allergan Reports Fourth Quarter and Full-Year 2018 Financial Results. Allergan News.
3. Vilazodone (Viibryd) Manufacturing Plant Report 2024. IMARC Group.
4. Viibryd Vilazodone Market Report 2024 (Global Edition). Cognitive Market Research.
5. Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results. PR Newswire.