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:	25
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
Martin Blomberg Jensen	PHASE2
Yale University	PHASE2
Astellas Pharma US, Inc.	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	8,871,761			Y
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	10,836,768
Astellas	VEOZAH	fezolinetant	TABLET;ORAL	216578-001	May 12, 2023		RX	Yes	Yes
Astellas	VEOZAH	fezolinetant	TABLET;ORAL	216578-001	May 12, 2023		RX	Yes	Yes	9,987,274

International Patents for fezolinetant

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3219715	N-ACYL-(3-SUBSTITUTED)-(8-SUBSTITUTED)-5,6-DIHYDRO- [1,2,4]TRIAZOLO[4,3-A]PYRAZINES EN TANT QU'ANTAGONISTES SÉLECTIFS DU RÉCEPTEUR NK-3, COMPOSITION PHARMACEUTIQUE ET PROCÉDÉS POUR UTILISATION DANS LES MALADIES À MÉDIATION PAR LE RÉCEPTEUR NK-3 (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)
Cyprus	1120307
Singapore	11201508005X	NOVEL 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
World Intellectual Property Organization (WIPO)	2011121137
Canada	2793313

Supplementary Protection Certificates for fezolinetant

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2948455	122024000025	Germany		PRODUCT NAME: FEZOLINETANT; REGISTRATION NO/DATE: EU/1/23/1771 20231207
2948455	PA2024513,C2948455	Lithuania		PRODUCT NAME: FEZOLINETANTAS; REGISTRATION NO/DATE: C(2023)8783 20231207
2948455	PA2024513	Lithuania		PRODUCT NAME: FEZOLINETANTAS; REGISTRATION NO/DATE: C(2023)8783 20231207
2948455	C202430026	Spain		PRODUCT NAME: FEZOLINETANT; NATIONAL AUTHORISATION NUMBER: EU/1/23/1771; DATE OF AUTHORISATION: 20231207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1771; DATE OF FIRST AUTHORISATION IN EEA: 20231207
2948455	CR 2024 00017	Denmark		PRODUCT NAME: FEZOLINETANT; REG. NO/DATE: EU/1/23/1771 20231212

Market Dynamics and Financial Trajectory for Fezolinetant

Last updated: February 25, 2026

What is Fezolinetant?

Fezolinetant is an orally active neurokinin-3 receptor (NK3R) antagonist developed by Janssen Pharmaceuticals. It targets vasomotor symptoms associated with menopause, primarily hot flashes. Its mechanism involves modulating neurokinin pathways involved in thermoregulation. The drug is in late-stage clinical trials and is positioned to compete in the hormone replacement therapy (HRT) and menopausal symptom market.

Market Size and Growth Drivers

Global Menopause Market

The menopause market encompasses therapies aimed at alleviating vasomotor symptoms, osteoporosis, and other age-related conditions. As of 2022, the global menopause therapeutics market was valued at approximately USD 4 billion. It is projected to grow at a compound annual growth rate (CAGR) of 6% to 8% through 2030, driven by:

• Aging female population: The number of women aged 50+ is forecasted to double by 2050, reaching over 2.1 billion.
• Increasing prevalence of vasomotor symptoms: Nearly 80% of women experience hot flashes during menopause.
• Unmet demand for non-hormonal options: Increased interest in alternatives to hormone therapy, especially post-Women’s Health Initiative (WHI) findings questioning hormone safety.

Competitive Landscape

Current standard options include hormone replacement therapy (HRT), SSRIs/SNRIs, and herbal supplements. HRT accounts for roughly 45% of market share but faces declining prescription rates due to safety concerns.

Upcoming entrants like fezolinetant aim to capture a portion of this unmet need with a non-hormonal, targeted mechanism.

Regulatory Status and Timeline

In December 2022, Janssen reported positive Phase 3 trial results for fezolinetant, with statistically significant reductions in hot flashes vs. placebo. A Regulatory Submission (New Drug Application, NDA) was filed with the FDA in early 2023. Approval expected by Q4 2023 or Q1 2024.

The European Medicines Agency (EMA) and other regulators are expected to follow, with approval anticipated by 2024-2025.

Revenue Potential and Financial Trajectory

Pricing Strategy

Pricing of fezolinetant is projected in line with current non-hormonal therapies. Estimated annual wholesale acquisition cost (WAC) ranges between USD 2,000 and USD 4,000 per patient, depending on dosing and region.

Market Penetration Scenarios

Scenario	Market Share	Peak Annual Revenue (USD billions)	Assumptions
Conservative	10% of US population	USD 0.3 billion	Post-launch, capturing 10% of women with moderate-severe vasomotor symptoms.
Moderate	25% increase in prescription rate	USD 0.6 billion	Rapid uptake due to safety profile and minimal side effects.
Aggressive	50% market share in key regions	USD 1.2 billion	Wide adoption driven by formulary inclusion and physician acceptance.

Forecasted Earnings Timeline

• 2024: Initial sales ramp-up in US, limited international rollout.
• 2025-2026: Expanding to European markets post-approval, growing market share.
• 2027 onwards: Potential pipeline expansion, including combination therapies or additional indications.

Cost Dynamics & Investment

Development costs for fezolinetant total approximately USD 400-500 million, including clinical trials and regulatory expenses. Janssen expects break-even within 3-5 years post-launch, assuming moderate market penetration. Ongoing marketing and education investments are estimated at USD 50-100 million annually.

Competitive Risks

• Delays in FDA approval could postpone revenue realization.
• Efficacy or safety concerns may impact uptake.
• Competition from existing non-hormonal therapies or future pipeline entrants.

Regulatory and Reimbursement Environment

Reimbursement for non-hormonal menopause therapies is increasing, supported by guidelines from the North American Menopause Society and other bodies. Payers may favor drugs with proven safety profiles and convenience of oral administration.

Key Takeaways

• Fezolinetant targets a multibillion-dollar market with significant unmet needs.
• Approval is anticipated in late 2023 or early 2024, enabling potentially substantial revenues.
• Market penetration depends on regulatory approval, physician adoption, and payer reimbursement policies.
• Long-term growth depends on positioning as a first-line non-hormonal option, with potential pipeline expansions.
• Competitive risk factors include delays, safety issues, and emerging therapies.

FAQs

1. What distinguishes fezolinetant from existing menopause therapies?
It is a non-hormonal, oral medication targeting neurokinin pathways, potentially offering a safer profile than hormone-based therapies.

2. What is the expected timeline for fezolinetant’s commercial success?
Regulatory approval is expected by late 2023 or early 2024; commercial success depends on market uptake over the subsequent 1-3 years.

3. How does fezolinetant’s pricing compare to other treatments?
Projected at USD 2,000-4,000 annually per patient, similar to other non-hormonal therapies.

4. What are the main barriers to market entry?
Regulatory approval delays, physician acceptance, payer reimbursement, and competition from existing treatments.

5. What future indications could enhance fezolinetant’s market size?
Potential expansion into treatment of other neurokinin-related conditions or adjunct therapy for osteoporosis.

References

1. Johnson & Johnson. (2023). Fezolinetant Phase 3 trial results. [Press release].
2. MarketWatch. (2023). Global menopause therapeutics market report.
3. Food and Drug Administration. (2023). Draft guidance for menopause therapy approval.
4. North American Menopause Society. (2022). Guidelines on non-hormonal menopause management.
5. Datamonitor. (2023). Menopause market forecast 2022-2030.