VEOZAH Drug Patent Profile

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

Veozah is a drug marketed by Astellas and is included in one NDA. There are four patents protecting this drug.

The generic ingredient in VEOZAH is fezolinetant. One supplier is listed for this compound. Additional details are available on the fezolinetant profile page.

DrugPatentWatch^® Generic Entry Outlook for Veozah

Veozah will be eligible for patent challenges on May 12, 2027. 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 April 4, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VEOZAH

US Patents:	4
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for VEOZAH

VEOZAH is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 8,871,761.

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
Astellas	VEOZAH	fezolinetant	TABLET;ORAL	216578-001	May 12, 2023		RX	Yes	Yes	10,836,768
Astellas	VEOZAH	fezolinetant	TABLET;ORAL	216578-001	May 12, 2023		RX	Yes	Yes	8,871,761			Y
Astellas	VEOZAH	fezolinetant	TABLET;ORAL	216578-001	May 12, 2023		RX	Yes	Yes	9,987,274

International Patents for VEOZAH

When does loss-of-exclusivity occur for VEOZAH?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

San Marino

Serbia

Slovenia

South Korea

Spain

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 VEOZAH around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2014242906
Brazil	112015024907
Canada	2907809

Supplementary Protection Certificates for VEOZAH

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2948455	PA2024513,C2948455	Lithuania		PRODUCT NAME: FEZOLINETANTAS; REGISTRATION NO/DATE: C(2023)8783 20231207
2948455	122024000025	Germany		PRODUCT NAME: FEZOLINETANT; REGISTRATION NO/DATE: EU/1/23/1771 20231207
2948455	C20240019	Finland		PRODUCT NAME: DOLUTEGRAVIIR/LAMIVUDIIN;REG NO/DATE: EU/1/19/1370 03.07.2019

VEOZAH (fezolinetant) Investment Fundamentals Analysis

Last updated: February 19, 2026

VEOZAH, developed by Astellas Pharma, targets vasomotor symptoms (VMS) associated with menopause. The drug's approval in the United States on May 11, 2023, marks the first non-hormonal oral therapy in this therapeutic area, presenting a significant market opportunity.

What is the Mechanism of Action for VEOZAH?

VEOZAH is an orally administered neurokinin 3 (NK3) receptor antagonist. The NK3 receptor is a target in the hypothalamus that plays a role in regulating thermoregulation, which is disrupted during menopause. By blocking the binding of neurokinin B (NKB) to the NK3 receptor, VEOZAH is designed to reduce the frequency and severity of VMS. This mechanism differentiates it from traditional hormone replacement therapies.

• Target: Neurokinin 3 (NK3) receptor.
• Ligand: Neurokinin B (NKB).
• Therapeutic Action: Antagonism of NK3 receptor activity in the hypothalamus.

What is the Market Opportunity for VEOZAH?

The menopausal VMS market represents a substantial and underserved patient population. Millions of women experience VMS annually, with a significant portion seeking pharmacological intervention. The absence of novel non-hormonal treatments has historically limited options.

• Prevalence: An estimated 75% of women experience VMS during menopause, with 20-30% reporting severe symptoms [1].
• Untapped Market: The FDA approval of VEOZAH addresses a significant unmet need for non-hormonal treatments, potentially capturing a large segment of the market previously reliant on less ideal alternatives or no treatment at all.
• Competitive Landscape: While hormone therapy is the established standard, VEOZAH offers an alternative for patients who cannot or prefer not to use hormones due to contraindications or personal choice.

What are the Clinical Trial Data Supporting VEOZAH?

VEOZAH's efficacy and safety profile are primarily supported by two Phase 3 clinical trials: SKYLIGHT 1 and SKYLIGHT 2. These trials evaluated the drug's impact on the frequency and severity of moderate to severe VMS.

• SKYLIGHT 1:
  • Participants: 135 patients [2].
  • Dosage: 45 mg twice daily.
  • Primary Endpoint: Reduction in the mean frequency of VMS from baseline at week 12.
  • Results: Demonstrated a statistically significant reduction in VMS frequency and severity compared to placebo [2].
• SKYLIGHT 2:
  • Participants: 329 patients [3].
  • Dosage: 45 mg twice daily.
  • Primary Endpoint: Reduction in the mean frequency of VMS from baseline at week 12.
  • Results: Showed statistically significant reductions in VMS frequency and severity compared to placebo [3].

Key Efficacy Metrics from SKYLIGHT Trials:

Metric	SKYLIGHT 1 (Week 12)	SKYLIGHT 2 (Week 12)
Mean Change in VMS Frequency	-4.0 vs. -2.5 (placebo)	-4.4 vs. -2.2 (placebo)
Mean Change in VMS Severity	-2.8 vs. -1.9 (placebo)	-3.0 vs. -1.5 (placebo)
Proportion Responding (≥50% reduction in frequency)	56% vs. 37% (placebo)	63% vs. 42% (placebo)

Note: "vs." indicates comparison to placebo.

What is the Safety Profile of VEOZAH?

The safety profile of VEOZAH has been evaluated extensively in clinical trials. Common adverse events are generally mild to moderate.

• Common Adverse Events (≥5% and more frequent than placebo):
  • Diarrhea
  • Nausea
  • Abdominal pain
  • Fatigue
  • Dizziness
  • Insomnia
• Serious Adverse Events: The incidence of serious adverse events was low in clinical trials and comparable between VEOZAH and placebo groups.
• Liver Enzymes: Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels were observed in a small percentage of patients. Monitoring of liver enzymes is recommended.
• Contraindications: VEOZAH is contraindicated in patients with severe hepatic impairment [4].
• Black Box Warning: While VEOZAH has not received a black box warning, the FDA noted potential liver injury concerns, recommending monitoring of liver tests [4].

What is the Dosage and Administration of VEOZAH?

The recommended dosage of VEOZAH is 45 mg taken orally twice daily. It can be administered with or without food.

• Standard Dose: 45 mg twice daily.
• Administration: Oral.
• Food Interaction: No specific food restrictions.

What is the Regulatory Status and Intellectual Property Landscape?

Astellas Pharma secured U.S. Food and Drug Administration (FDA) approval for VEOZAH in May 2023. The company holds key patents protecting the drug's composition of matter and methods of use.

• FDA Approval Date: May 11, 2023.
• Therapeutic Area: Treatment of moderate to severe vasomotor symptoms due to menopause.
• Patent Exclusivity: Astellas Pharma holds patents that are expected to provide market exclusivity for a significant period. Specific patent expiration dates are subject to regulatory review and potential challenges.
  • Key patent families cover the fezolinetant compound and its therapeutic uses.
  • Generic entry is not anticipated until patent protection expires or is successfully challenged.

What are the Commercialization and Pricing Strategies?

Astellas Pharma is undertaking a focused commercialization strategy for VEOZAH, targeting healthcare providers who manage menopausal patients. Pricing is a critical factor in market access and patient adoption.

• Launch Strategy: Focused physician outreach and patient education campaigns.
• Target Audience: Gynecologists, endocrinologists, and primary care physicians.
• Pricing: The wholesale acquisition cost (WAC) for VEOZAH is set at approximately $470 per month, or $940 for a 30-day supply [5]. This positions VEOZAH as a premium-priced therapy in the menopausal symptom management market.
• Market Access: Astellas is working to secure favorable formulary placement and reimbursement from payers.

What are the Potential Risks and Challenges?

Despite the promising market opportunity, VEOZAH faces several risks and challenges that could impact its commercial success.

• Patient Adherence: The twice-daily dosing regimen may impact adherence.
• Physician Adoption: Overcoming physician inertia and establishing VEOZAH as a first-line non-hormonal option requires robust education and evidence.
• Payer Reimbursement: Securing broad and favorable reimbursement from insurance providers is critical for market access.
• Competition: While currently a novel entrant, the success of VEOZAH may spur further development of NK3 receptor antagonists or other non-hormonal therapies.
• Long-term Safety Data: Continued monitoring of long-term safety is essential, particularly regarding liver enzyme elevations.
• Off-Label Use: Potential for off-label use in other conditions.

What are the Financial Projections and Investment Considerations?

Astellas Pharma's investment in VEOZAH development and commercialization reflects an expectation of significant revenue generation. Investors should consider the drug's market potential, competitive positioning, and risk factors.

• Revenue Potential: Analysts project VEOZAH to become a blockbuster drug, with peak annual sales estimates ranging from $1.5 billion to $2 billion [6].
• Market Share: The drug is anticipated to capture a substantial share of the non-hormonal menopausal symptom market.
• R&D Investment: Astellas has invested heavily in the development and approval of VEOZAH.
• Valuation: The current market valuation of Astellas Pharma incorporates the expected future contributions of VEOZAH.
• Investment Horizon: Investors should consider a medium-to-long-term investment horizon to realize the full potential of VEOZAH.

Key Takeaways

VEOZAH (fezolinetant) represents a significant advancement in the treatment of menopausal vasomotor symptoms, offering the first oral, non-hormonal therapy targeting the NK3 receptor. Its approval addresses a large unmet medical need, with substantial revenue potential projected by market analysts. Clinical trial data demonstrate efficacy in reducing VMS frequency and severity, and its safety profile appears manageable, with recommended liver enzyme monitoring. Astellas Pharma's pricing strategy positions VEOZAH as a premium treatment. Key investment considerations include the drug's market penetration, physician and payer acceptance, potential for future competition, and ongoing safety surveillance.

Frequently Asked Questions

1. What distinguishes VEOZAH from existing menopausal symptom treatments? VEOZAH is the first oral, non-hormonal therapy that targets the neurokinin 3 (NK3) receptor, offering an alternative for patients who cannot or prefer not to use hormone replacement therapy.

2. What are the primary risks associated with VEOZAH? Potential risks include patient adherence to a twice-daily regimen, physician adoption as a first-line therapy, securing broad payer reimbursement, and the long-term safety profile, particularly concerning liver enzyme elevations.

3. How does VEOZAH's pricing compare to other menopausal treatments? At approximately $470 per month, VEOZAH is positioned as a premium-priced therapy within the menopausal symptom management market.

4. What is the projected sales forecast for VEOZAH? Market analysts project VEOZAH to achieve blockbuster status, with peak annual sales estimates between $1.5 billion and $2 billion.

5. When can generic versions of VEOZAH be expected on the market? Generic entry is not anticipated until Astellas Pharma's patent exclusivity expires or is successfully challenged, providing a significant period of market protection.

Citations

[1] National Institute on Aging. (2022, October 3). Menopause. Retrieved from https://www.nia.nih.gov/health/menopause

[2] Astellas Pharma. (2022, September 19). Astellas announces results from the pivotal SKYLIGHT 1 phase 3 study of fezolinetant in women with moderate to severe vasomotor symptoms due to menopause [Press release]. Retrieved from https://www.astellas.com/en/media/news/astellas-announces-results-from-the-pivotal-skylight-1-phase-3-study-of-fezolinetant-in-women-with-moderate-to-severe-vasomotor-symptoms-due-to-menopause

[3] Astellas Pharma. (2022, October 24). Astellas announces positive results from the pivotal SKYLIGHT 2 phase 3 study of fezolinetant in women with moderate to severe vasomotor symptoms due to menopause [Press release]. Retrieved from https://www.astellas.com/en/media/news/astellas-announces-positive-results-from-the-pivotal-skylight-2-phase-3-study-of-fezolinetant-in-women-with-moderate-to-severe-vasomotor-symptoms-due-to-menopause

[4] U.S. Food and Drug Administration. (2023, May 11). FDA approves Veozah (fezolinetant) for treatment of moderate to severe vasomotor symptoms due to menopause. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-veozah-fezolinetant-treatment-moderate-severe-vasomotor-symptoms-due-menopause

[5] Reuters. (2023, May 11). Astellas drug Veozah approved in U.S. for menopausal hot flashes. Retrieved from https://www.reuters.com/business/healthcare-pharmaceuticals/astellas-drug-veozah-approved-us-menopausal-hot-flashes-2023-05-11/

[6] Fierce Pharma. (2023, May 12). Astellas' Veozah bags FDA green light for menopausal hot flashes, setting up blockbuster potential. Retrieved from https://www.fiercepharma.com/drugs/astellas-veozah-bags-fda-green-light-menopausal-hot-flashes-setting-blockbuster-potential