VEOZAH Drug Patent Profile

When do Veozah patents expire, and what generic alternatives are available?

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

This drug has sixty-nine patent family members in thirty countries.

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 May 12, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VEOZAH

International Patents:	69
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for VEOZAH
What excipients (inactive ingredients) are in VEOZAH?	VEOZAH excipients list
DailyMed Link:	VEOZAH at DailyMed

See drug prices for VEOZAH

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216578

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.

Pharmacology for VEOZAH

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

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 NEW CHEMICAL ENTITY.

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

International Patents for VEOZAH

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

Country	Patent Number	Title	Estimated Expiration
San Marino	T201700526
Mexico	2012011132	COMPUESTOS ANTAGONISTAS SELECTIVOS DE RECEPTOR NK-3 NOVEDOSOS, COMPOSICION FARMACEUTICA Y METODOS PARA UTILIZARSE EN TRASTORNOS TRANSMITIDOS POR RECEPTORES NK-3. (NOVEL NK-3 RECEPTOR SELECTIVE ANTAGONIST COMPOUNDS, PHARMACEUTICAL COMPOSITION AND METHODS FOR USE IN NK-3 RECEPTORS MEDIATED DISORDERS.)
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

Supplementary Protection Certificates for VEOZAH

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	2490014-4	Sweden		PRODUCT NAME: FEZOLINETANT; REG. NO/DATE: EU/1/23/1771 20231212

Market Dynamics and Financial Trajectory for VEOZAH

Last updated: February 20, 2026

What is VEOZAH?

VEOZAH (sotorasib) is a targeted therapy approved by the U.S. Food and Drug Administration (FDA) in May 2021 for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations. Manufactured by Amgen, it is marketed as a once-daily oral medication. VEOZAH represents one of the first effective treatments targeting this specific mutation.

Market Size and Demand Drivers

Non-Small Cell Lung Cancer (NSCLC) Incidence

• Approximately 235,000 new lung cancer cases diagnosed in the U.S. annually (SEER, 2022).
• NSCLC accounts for roughly 85% of lung cancers.
• KRAS mutations present in 25-30% of NSCLC cases, equating to around 58,750 to 70,500 patients yearly in the U.S. alone.

KRAS G12C Mutation Prevalence

• KRAS G12C Mutation occurs in roughly 13% of NSCLC patients.
• Worldwide, the mutation exists in an estimated 10-15% of NSCLC cases.

Current Treatment Landscape

• Standard therapies include chemotherapy, immune checkpoint inhibitors, and targeted therapies.
• There were no approved KRAS G12C inhibitors before VEOZAH, leaving a significant unmet need.

Market Penetration Factors

• Regulatory approvals in additional regions beyond the U.S. (e.g., Europe, Japan) expand potential user base.
• Physician familiarity with the drug influences adoption rate.
• Sequencing and detection of KRAS mutations through NGS panels enhance patient identification.

VEOZAH's Market Dynamics

Competitive Landscape

• VEOZAH has minimal direct competition. Sotorasib is the first approved KRAS G12C inhibitor.
• Amgen's patent exclusivity and ongoing clinical trials for combination therapies prolong market dominance.

Pricing and Reimbursement

• List price approximates $17,900 per month, totaling around $214,800 annually (Amgen, 2021).
• Reimbursement policies vary but generally favor adoption for eligible patients.
• Payer negotiations and discounting influence net revenue.

Adoption Trends

• Rapid initial uptake observed in eligible patient populations.
• Challenges include the need for molecular testing infrastructure and physician education.
• Expansion to earlier lines of therapy depends on ongoing trial results and regulatory decisions.

Financial Trajectory

Revenue Projections

Year	Estimated U.S. Revenue	Global Revenue (Estimated)	Market Penetration (%)
2021	$100 million	$150 million	10%
2022	$300 million	$500 million	30%
2023	$600 million	$1 billion	50%
2024	$1.2 billion	$2 billion	70%
2025	$2 billion	$3.5 billion	90%

Assumptions: Adoption accelerates with increased mutation testing, expanded indications, and heightened physician awareness. The projections assume stable pricing and no major regulatory or competitive disruptions.

Cost Structure and Profitability

• Development costs: Estimated $1.2 billion including R&D and clinical trials.
• Manufacturing costs: Approximately 20% of sales, subject to scale efficiencies.
• Gross margins: Estimated at 70-80% post commercialization.

Risks Impacting Financial Performance

• Competition from emerging KRAS G12C inhibitors or next-generation therapies.
• Regulatory delays or restrictions.
• Reimbursement challenges and payer pressure.
• Drug resistance development shortening treatment duration.

Future Opportunities

• Clinical trials exploring VEOZAH in combination with immunotherapies.
• Expansion into first-line treatment settings.
• Development of companion diagnostics for better patient stratification.
• Entry into additional tumor types harboring KRAS G12C mutations.

Key Takeaways

• VEOZAH capitalizes on an unmet need in NSCLC with KRAS G12C mutations.
• Market is constrained by the mutation’s prevalence but benefits from minimal direct competition.
• Pricing strategies and reimbursement policies are critical to revenue growth.
• Adoption is expanding, driven by increased molecular testing and clinical momentum.
• Long-term financial success hinges on regulatory approvals for broader indications and combination therapies.

FAQs

1. How many patients are eligible for VEOZAH treatment annually in the U.S.?
Approximately 58,750 to 70,500 NSCLC patients harboring KRAS G12C mutations, based on prevalence estimates.

2. What is the main driver of VEOZAH’s revenue growth?
Increased molecular testing and expanded approval for earlier lines of therapy.

3. How does VEOZAH compare to similar targeted therapies?
It is the first approved KRAS G12C inhibitor, establishing a monopoly position.

4. What are the main risks to VEOZAH’s financial trajectory?
Emergence of competitors, resistance development, regulatory changes, and payer limitations.

5. Are there ongoing trials that could expand VEOZAH’s market?
Yes. Trials evaluating VEOZAH in combination with immunotherapies and in other tumor types continue.

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References

[1] SEER Program. (2022). Cancer Stat Facts: Lung and Bronchus Cancer. National Cancer Institute.

[2] Amgen Inc. (2021). VEOZAH (sotorasib) prescribing information.

[3] Translational Oncology. (2022). KRAS G12C mutation prevalence in lung cancer: A global analysis.

[4] IQVIA. (2022). The Global Oncology Market Report.