VOQUEZNA Drug Patent Profile

Which patents cover Voquezna, and when can generic versions of Voquezna launch?

Voquezna is a drug marketed by Phathom and is included in three NDAs. There are two patents protecting this drug.

This drug has one hundred and three patent family members in forty-three countries.

The generic ingredient in VOQUEZNA is amoxicillin; clarithromycin; vonoprazan fumarate. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; clarithromycin; vonoprazan fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Voquezna

Voquezna will be eligible for patent challenges on May 3, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 3, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VOQUEZNA

International Patents:	103
US Patents:	2
Applicants:	1
NDAs:	3

US Patents and Regulatory Information for VOQUEZNA

VOQUEZNA is protected by two US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-001	Nov 1, 2023		RX	Yes	No	7,977,488			Y
Phathom	VOQUEZNA TRIPLE PAK	amoxicillin; clarithromycin; vonoprazan fumarate	CAPSULE, TABLET, TABLET;ORAL	215152-001	May 3, 2022		RX	Yes	Yes
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-002	Nov 1, 2023		RX	Yes	Yes	9,186,411		Y
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-001	Nov 1, 2023		RX	Yes	No
Phathom	VOQUEZNA DUAL PAK	amoxicillin; vonoprazan fumarate	CAPSULE, TABLET;ORAL	215153-001	May 3, 2022		RX	Yes	Yes	9,186,411		Y
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-002	Nov 1, 2023		RX	Yes	Yes	7,977,488			Y

International Patents for VOQUEZNA

When does loss-of-exclusivity occur for VOQUEZNA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Japan

Malaysia

Mexico

Morocco

New Zealand

Peru

Singapore

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VOQUEZNA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2936400
Japan	2013047239	PHARMACEUTICAL COMPOSITION
South Korea	20080039998
Spain	2391757
Georgia, Republic of	P20146166
Montenegro	P10009

Investment Scenario and Fundamentals Analysis for VOQUEZNA

Last updated: February 20, 2026

What Is VOQUEZNA?

VOQUEZNA (vilazodone) is an anti-depressant marketed by Neurocrine Biosciences. Approved by the FDA in 2019, it targets major depressive disorder (MDD). The drug operates as a selective serotonin reuptake inhibitor (SSRI) and partial 5-HT1A receptor agonist, aiming to improve antidepressant response with fewer side effects.

Market Overview

The global depression treatment market was valued at approximately $16 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 3.9% through 2030. Key factors include rising mental health awareness and increased prescription of antidepressants.

Major competitors include:

Drug	Class	Year Approved	Market Share (2022)	Notable Features
Prozac (fluoxetine)	SSRI	1987	12%	Well-established, generic
Paxil (paroxetine)	SSRI	1992	8%	High side-effect profile
Zoloft (sertraline)	SSRI	1991	10%	Widely prescribed
Vilazodone (VOQUEZNA)	SSRI + 5-HT1A partial agonist	2019	<1% in MDD market	Novel mechanism, potential niche

Market Penetration and Adoption

VOQUEZNA remains underpenetrated due to competitive dominance by generics and established brands. Its unique mechanism may target patients with partial response to traditional SSRIs or those intolerant to side effects.

Prescription volume data (2022):

• Estimated 500,000 prescriptions in the U.S.
• Limited international sales, primarily in the U.S.
• Market share in depression medications remains below 1%, suggesting significant growth potential if commercialization expands.

Financial Fundamentals & Investment Indicators

Available financial disclosures indicate modest revenues:

Metric	2022	2023 (Estimate)	Notes
Revenue ($ millions)	$20	$50	Growth tied to sales expansion
R&D expenses ($ millions)	$7	$8	Focused on line extensions and formulations
Marketing & Admin ($ millions)	$10	$12	scaled to support commercialization

Profitability remains negative due to high R&D and marketing costs, with potential for revenue turn positive upon increased adoption.

Investment Considerations

Strengths

• Novel mechanism offering potential niche market.
• Growing awareness of depression treatments.
• Opportunities in expanding indications, e.g., generalized anxiety disorder.

Weaknesses

• Limited market share and low current revenue.
• Competition from well-established drugs.
• Dependence on successful commercialization and formulary acceptance.

Opportunities

• Line extensions, such as alternative formulations.
• International expansion.
• Strategic partnerships for marketing.

Threats

• Market saturation by generic SSRIs.
• Potential regulatory changes affecting approval.
• Uncertain reimbursement landscape.

Regulatory and Commercial Outlook

The drug's approval process faced no major hurdles, and the company has initiated global expansion plans. Patent status remains stable through 2030, but generic competition on the basic SSRIs limits upside unless VOQUEZNA sustains a premium niche.

Valuation and Investment Risks

Given limited revenue and ongoing R&D costs, valuation models (DCF, comparables) suggest high risk. Upside hinges on increasing prescriptions, expanding indications, and potential pricing power.

Key Takeaways

• VOQUEZNA operates in a competitive depression treatment market with only marginal current market share.
• Its unique mechanism provides differentiation but has yet to translate into substantial revenue.
• Investment risk is high due to market saturation, competition, and early-stage commercial success.
• Near-term value depends on expanding prescriptions and international markets.
• Long-term prospects hinge on line extensions and potential new indications.

FAQs

1. How does VOQUEZNA compare to other antidepressants?
It combines SSRI activity with 5-HT1A partial agonism, potentially reducing side effects and improving response, positioning it as a niche therapy.

2. What are the key hurdles for market penetration?
Establishing prescriber confidence, competing with generic SSRIs, and securing formulary placements.

3. What regulatory risks does VOQUEZNA face?
Potential delays in approvals for new indications and pricing negotiations could impact revenue.

4. How significant is patent protection for VOQUEZNA?
Patents extend until approximately 2030, providing market exclusivity but facing eventual patent cliffs and generic entry.

5. What is the outlook for international expansion?
Limited current presence outside the U.S., but plans exist, offering growth opportunities if regulatory and market access barriers are managed.

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References

[1] Neurocrine Biosciences. (2022). Annual Report 2022.
[2] MarketWatch. (2023). Depression Treatment Market Analysis.
[3] U.S. Food and Drug Administration. (2019). FDA Approval for VOQUEZNA.
[4] Grand View Research. (2023). Global Depression Treatment Market.