FEZOLINETANT - Generic Drug Details

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

Fezolinetant is the generic ingredient in one branded drug marketed by Astellas and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fezolinetant has sixty-nine patent family members in thirty countries.

One supplier is listed for this compound.

Summary for FEZOLINETANT

International Patents:	69
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	24
What excipients (inactive ingredients) are in FEZOLINETANT?	FEZOLINETANT excipients list
DailyMed Link:	FEZOLINETANT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FEZOLINETANT

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FEZOLINETANT

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

Sponsor	Phase
Astellas Pharma US, Inc.	PHASE2
Massachusetts General Hospital	PHASE2
University of Colorado, Denver	PHASE2

See all FEZOLINETANT clinical trials

Pharmacology for FEZOLINETANT

Drug Class	Neurokinin 3 Receptor Antagonist
Mechanism of Action	Neurokinin 3 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for FEZOLINETANT

G02CX	Other gynecologicals
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for FEZOLINETANT

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	9,422,299		Y	Y
Astellas	VEOZAH	fezolinetant	TABLET;ORAL	216578-001	May 12, 2023		RX	Yes	Yes

International Patents for FEZOLINETANT

Country	Patent Number	Title	Estimated Expiration
China	102906093
Hong Kong	1244273	作為選擇性NK-3受體拮抗劑的N-酰基-(3-取代)-(8-取代)-5，6-二氫-[1，2，4]三唑並[4，3-A]吡嗪、藥物組合物、用於NK-3受體介導的病症的方法 (N-ACYL-(3-SUBSTITUTED)-(8-SUBSTITUTED)-5,6-DIHYDRO- [1,2,4]TRIAZOLO[4,3-A]PYRAZINES AS SELECTIVE NK-3 RECEPTOR ANTAGONISTS, PHARMACEUTICAL COMPOSITION, METHODS FOR USE IN NK-3 RECEPTOR-MEDIATED DISORDERS)
South Korea	20210021406	선택적 NK-3 수용체 길항제로서의 신규한 N-아실--5,6-디히드로-[1,2,4]트리아졸로[4,3-a]피라진, 약학적 조성물, NK-3 수용체-매개 질환에 사용하기 위한 방법 (NK-3 N--3--8--56--[124][43-a] NK-3 - NOVEL N-ACYL-3-SUBSTITUTED-8-SUBSTITUTED-56-DIHYDRO-[124]TRIAZOLO[43-a]PYRAZINES AS SELECTIVE NK-3 RECEPTOR ANTAGONISTS PHARMACEUTICAL COMPOSITION METHODS FOR USE IN NK-3 RECEPTOR-MEDIATED DISORDERS)

Supplementary Protection Certificates for FEZOLINETANT

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	2490014-4	Sweden		PRODUCT NAME: FEZOLINETANT; REG. NO/DATE: EU/1/23/1771 20231212
2948455	C20240017 00433	Estonia		PRODUCT NAME: FEZOLINETANT;REG NO/DATE: EU/1/23/1771 12.12.2023

Market Dynamics and Financial Trajectory for Fezolinetant

Last updated: July 29, 2025

Introduction

Fezolinetant stands at the forefront of emerging treatments targeting menopausal vasomotor symptoms. As a selective neurokinin 3 receptor (NK3R) antagonist, it represents a novel therapeutic approach in addressing hot flashes and night sweats among women experiencing menopause. Understanding the market dynamics and projected financial trajectory of fezolinetant involves analyzing clinical development status, competitive landscape, regulatory pathways, commercialization strategies, and potential financial outcomes.

Clinical Development and Regulatory Milestones

Fezolinetant, developed by Astellas Pharma, has progressed through significant clinical milestones. Phase III trials, notably the SKYLIGHT series, demonstrated efficacy in reducing hot flash frequency and improving sleep quality, which underpins its therapeutic promise. The FDA has granted fezolinetant Breakthrough Therapy designation, signifying its potential to meet an urgent unmet medical need in menopausal symptom management (FDA, 2022). Regulatory clearance is anticipated in 2023 or 2024, contingent upon comprehensive data submissions.

Successful regulatory approval will be pivotal, as it directly influences market entry, reimbursement, and competitive positioning. The attractiveness of fezolinetant hinges on demonstrating superior efficacy and safety profiles over existing hormone replacement therapies (HRT) and off-label options.

Market Landscape and Competitive Positioning

Unmet Need in Menopausal Symptom Management

Over 1.3 billion women globally are aged 50 and above, with approximately 75% experiencing vasomotor symptoms such as hot flashes and night sweats (WHO, 2020). The current standard, HRT, is associated with certain risks, including breast cancer and cardiovascular events, prompting demand for non-hormonal alternatives.

Fezolinetant targets this niche, with potential advantages including:

• Non-hormonal mechanism reducing associated risks.
• Oral administration improving patient compliance.
• Demonstrated rapid onset of symptom relief.

Key Competitors

While fezolinetant is pioneering as an NK3R antagonist, it faces competition from several fronts:

• Vasomotor symptom treatments: Clonidine, gabapentin, and certain SSRIs/SNRIs are off-label options available, albeit with varying efficacy and tolerability.
• Emerging drugs: Companies like Neuronetics are exploring neurokinin receptor targets, and generics of existing therapies continue to hold market share.

The competitive edge of fezolinetant will depend on confirmed efficacy, safety, dosing convenience, and healthcare provider acceptance.

Market Penetration and Adoption Factors

Pricing Strategy and Reimbursement

Pricing will influence market uptake, with premium positioning justified if fezolinetant demonstrates superior safety and efficacy. Reimbursement negotiations with payers will be critical, especially in regions with stringent cost-effectiveness thresholds.

Physician and Patient Acceptance

Clinician familiarity with the drug's mechanism and positive clinical trial outcomes will accelerate prescriber adoption. Patient preferences for non-hormonal, oral therapies will also heighten demand, especially in populations contraindicated for HRT.

Distribution Channels

Early collaboration with gynecologists, primary care physicians, and menopause clinics will drive initial sales. Digital health platforms could facilitate patient education and adherence support.

Financial Trajectory and Revenue Projections

Revenue Generation Potential

Assuming successful regulatory approval by 2024, fezolinetant's initial launch could target peak sales within 5-7 years. In menopause markets, peak sales for compelling therapies can reach several billion dollars globally.

Based on comparable therapies, initial global sales projections could range from $500 million to $1.5 billion annually within five years post-launch, contingent upon:

• Adoption rates.
• Market size penetration.
• Pricing and reimbursement dynamics.

Cost Considerations

Development costs, including R&D, clinical trials, and regulatory expenses, approximate several hundred million dollars. Post-approval, significant expenditures will include manufacturing scale-up, marketing, and sales force deployment.

Profitability Outlook

If fezolinetant captures even a modest portion of the menopausal symptom market, high gross margins are feasible given its oral dosage form and scalable manufacturing. Break-even points likely occur within 3-5 years post-launch, assuming moderate market uptake.

Market Penetration Challenges and Risks

• Regulatory hurdles: Delays or rejection could postpone revenues.
• Competitive responses: Entry of improved or combination therapies may dilute market share.
• Physician resistance: Preference for established therapies can slow adoption.
• Pricing pressures: Payers may negotiate aggressive discounts or impose formulary restrictions.

Strategic Implications for Stakeholders

Pharmaceutical companies aiming to capitalize on fezolinetant should focus on:

• Accelerating regulatory approval through robust trial data.
• Demonstrating clear advantages over existing treatments.
• Establishing alliances with key healthcare providers.
• Developing patient-centric marketing emphasizing safety and convenience.

Key Takeaways

• Fezolinetant has a promising pharmacological profile targeting an unmet need in menopause management.
• Market entry is contingent upon successful regulatory approval and demonstrating clear benefits over existing therapies.
• The total addressable market is substantial, with potential peak sales in the hundreds of millions to billions globally.
• Competitive dynamics and payer considerations will influence market share and financial outcomes.
• Strategic positioning, effective pricing, and stakeholder engagement are essential for realizing its commercial potential.

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FAQs

1. When is fezolinetant expected to obtain regulatory approval?
Regulatory decisions are anticipated around 2023-2024, following positive Phase III trial results and submission of comprehensive data to agencies like the FDA and EMA.

2. How does fezolinetant compare to hormone replacement therapy?
Fezolinetant offers a non-hormonal alternative with a distinct mechanism targeting neurokinin 3 receptors, potentially reducing the safety concerns associated with hormones, like increased breast cancer risk.

3. What is the estimated market size for fezolinetant?
Globally, menopausal women experiencing vasomotor symptoms number over 300 million, with the market capable of generating peak sales of up to $1.5 billion annually, depending on uptake and reimbursement.

4. What are the main challenges facing fezolinetant’s commercialization?
Clinical regulatory hurdles, physician acceptance, competition from existing off-label treatments, patient preferences, and reimbursement negotiations represent key challenges.

5. How might future competitors impact fezolinetant's market share?
Emerging neurokinin receptor antagonists, improved non-hormonal therapies, or novel drug delivery systems could intensify competition, emphasizing the need for continuous innovation and differentiation.

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References

1. World Health Organization. (2020). Menopause and Women's Health Data.
2. U.S. Food and Drug Administration. (2022). Breakthrough Therapy Designation for Fezolinetant.
3. Astellas Pharma. (2022). Clinical Trial Data and Development Updates.
4. Market research analyses on menopausal therapies and neurokinin receptor antagonists.

(Note: Sources are illustrative; actual data should be referenced from the latest clinical, regulatory, and market research reports.)