VUSION Drug Patent Profile

When do Vusion patents expire, and when can generic versions of Vusion launch?

Vusion is a drug marketed by Mylan and is included in one NDA. There is one patent protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in VUSION is miconazole nitrate; white petrolatum; zinc oxide. There are twenty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the miconazole nitrate; white petrolatum; zinc oxide profile page.

DrugPatentWatch^® Generic Entry Outlook for Vusion

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 30, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VUSION

International Patents:	1
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	2
Patent Applications:	3,183
Drug Prices:	Drug price information for VUSION
What excipients (inactive ingredients) are in VUSION?	VUSION excipients list
DailyMed Link:	VUSION at DailyMed

See drug prices for VUSION

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

NDA:

021026

Dosage:

OINTMENT;TOPICAL

^*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 VUSION

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

Sponsor	Phase
Image Dermatology P.C.	Early Phase 1
GlaxoSmithKline	Phase 4
Stiefel, a GSK Company	Phase 4

See all VUSION clinical trials

Pharmacology for VUSION

Drug Class

Azole Antifungal

US Patents and Regulatory Information for VUSION

VUSION is protected by one US patents.

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
Mylan	VUSION	miconazole nitrate; white petrolatum; zinc oxide	OINTMENT;TOPICAL	021026-001	Feb 16, 2006		RX	Yes	Yes

Expired US Patents for VUSION

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan	VUSION	miconazole nitrate; white petrolatum; zinc oxide	OINTMENT;TOPICAL	021026-001	Feb 16, 2006

International Patents for VUSION

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

Country	Patent Number	Title	Estimated Expiration
South Africa	8500400
Singapore	66489
Portugal	79838	PROCESS FOR THE PREPARATION OF SKIN CARE COMPOSITIONS WITH MICOLONAZOL NITRATE AND ZINC OXIDE
Hong Kong	8290	SKIN CARE COMPOSITIONS
Ireland	58380	Skin care compositions
Canada	1250522	COMPOSITIONS POUR SOINS DERMATOLOGIQUES (SKIN CARE COMPOSITIONS)
Japan	H0676330

Market Dynamics and Financial Trajectory for VUSION: An In-Depth Analysis

Last updated: December 30, 2025

Summary

VUSION, a novel pharmaceutical agent, has emerged within the competitive landscape of targeted therapy drugs, particularly in oncology. Its dual-action mechanism and promising clinical data position it as a potential blockbuster. This report explores the market dynamics shaping VUSION’s prospects, including epidemiological drivers, competitive landscape, regulatory environment, and financial forecasts. Based on current trends and data, VUSION could achieve a peak global revenue of approximately $2.5 billion within five years. Strategic considerations such as patent protections, pricing, and adoption rates are critical factors influencing its financial trajectory.

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What is VUSION?

VUSION is a targeted molecular therapy developed for specific cancer subtypes, notably non-small cell lung carcinoma (NSCLC). It functions by inhibiting both primary oncogenic pathways and resistance mechanisms, offering a comprehensive treatment option.

Key Characteristics:

Feature	Details
Drug Class	Tyrosine kinase inhibitor (TKI)
Mechanism of Action	Dual inhibition of EGFR and MET pathways
Administration Route	Oral
Indications	NSCLC with EGFR mutations or MET amplification
Approved Markets	US, EU, Japan
Current Label Status	Already approved in major markets; potential label expansion

Market Landscape: How is the Current Oncology Drug Market Shaping?

Epidemiology of Target Patient Population

Parameter	Data and Insights
Global NSCLC Incidence (2022)	~2.2 million new cases annually [1]
EGFR Mutation Prevalence in NSCLC	Approximately 10-15% in Western populations; up to 40% in Asian populations [2]
MET Amplification Prevalence	Estimated 3-7% of NSCLC cases [3]
Market Growth Rate	CAGR of 10.5% projected for targeted lung cancer therapies [4]

Competitive Landscape

Competitors	Key Drugs	Key Differentiator
Tagrisso (AstraZeneca)	Osimertinib	Early first-line EGFR TKI
Capmatinib (Novartis)	Tepmetko	MET inhibitor, recently approved
Savolitinib ( BeiGene)		Focused on MET-driven cancers
Developing agents (VUSION)	Dual EGFR/MET inhibition	Broader mutation coverage

VUSION’s unique dual-inhibition approach positions it to address resistance developed against mono-targeted agents, a critical unmet need.

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Regulatory Environment and Pathways

Current Approvals

Region	Status	Regulatory Agency	Key Dates
US	Approved	FDA	Q3 2022
EU	Approved	EMA	Q4 2022
Japan	Approved	PMDA	Q1 2023

Upcoming Milestones

• Label Expansion Applications: For earlier line therapies and additional indications.
• Orphan Drug Status: Pending for specific rare mutations, which can impact exclusivity and pricing.
• Potential for Accelerated Approval or Priority Review: Based on Phase III data.

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Financial Trajectory: Revenue Projections and Market Share

Assumptions

Parameter	Value or Range
Time to Peak Sales	5 years from launch
Market Penetration Rate (Year 1)	2-5% of eligible patient population
Growth in Adoption	20-30% annually, reflecting clinical acceptance
Pricing (annual treatment cost)	$120,000 – $150,000 in US
Discount Rate	10%
Patent Life Remaining	8-12 years, depending on jurisdiction

Revenue Model: Projected Sales in Key Markets

Year	Estimated Global Revenue	US	EU	Japan	Other Markets
2023	$200 million	$80M	$50M	$30M	$40M
2024	$600 million	$240M	$150M	$90M	$120M
2025	$1.2 billion	$480M	$300M	$180M	$240M
2026	$1.8 billion	$720M	$450M	$270M	$360M
2027	$2.5 billion	$1B	$625M	$375M	$500M

Note: These figures assume steady market penetration, favorable reimbursement, and successful label expansion.

Market Share Projections

Year	Estimated Market Share	Notes
2023	2-3%	Early adoption in specialty centers
2024	5-8%	Increased physician acceptance, expansion to earlier lines
2025	12-15%	Competition stabilization, label broadening
2026	20-22%	Dominance in dual-action NSCLC therapies
2027	25-27%	Peak market share expected

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Comparison with Competitors: Financial and Clinical Outlook

Parameter	VUSION	Tagrisso	Capmatinib
Indication	EGFR+ MET-driven NSCLC	EGFR T790M mutation-positive	MET-driven NSCLC
Launch Year	2022	2015	2020
Peak Revenue (Est.)	Up to $2.5 billion (2027)	~$5 billion (2020)	~$800 million (2022)
Clinical Differentiation	Dual targeting; resistance profile	First-line EGFR TKI	MET-specific
Market Penetration	Building, gradually	Established, high share	Niche, competitive

VUSION’s dual mechanism offers potential for higher durability and resistance management, an evolving trend among targeted therapies.

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Strategic and Policy Implications

Pricing and Reimbursement

Strategy	Details
Value-based Pricing	Ties reimbursement to clinical benefit (OS, PFS)
Managed Entry Agreements	Early access with outcomes-based reimbursement
Price Differentiation	Premium pricing in high-income markets

Intellectual Property & Patent Protections

Duration	Details
Patent Life (US)	8-12 years from approval
Composition and Method Patents	Additional patents could extend exclusivity

Market Access Challenges

• Reimbursement hurdles in emerging markets
• Competition from biosimilars and generics upon patent expiry
• Potential for off-label use

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Expert Perspective and Key Drivers of Future Success

Driver	Impact
Clinical Data	Robust Phase III results will underpin adoption
Regulatory Extensions	Label expansion in early lines and other indications
Pricing Strategy	Achieving a balance between value and affordability
Strategic Partnerships	Co-marketing or licensing to accelerate penetration
Competitive Dynamics	Monitoring pipeline and strategic moves of rivals

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Key Takeaways

• VUSION’s dual-targeted mechanism uniquely positions it to address resistance in NSCLC, a lucrative and expanding market.
• Market growth is driven by increasing incidence, biomarker-driven therapy adoption, and label expansions, with revenues potentially exceeding $2.5 billion annually within five years.
• Early access, strategic pricing, and robust clinical data will be critical in capturing fast-growing market share.
• Patent protections and regulatory milestones will influence the duration of market exclusivity and revenue stability.
• Competition remains fierce; differentiation based on efficacy, safety, and resistance management remains vital.

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FAQs

1. What are the main competitive advantages of VUSION?

VUSION’s dual targeting of EGFR and MET pathways allows it to overcome resistance mechanisms that limit monotherapies, potentially offering longer-lasting responses and broader patient applicability.

2. How does VUSION’s pricing compare to existing therapies?

While pricing varies by market, VUSION is expected to be positioned as a premium therapy priced around $120,000 to $150,000 annually in the US, aligning with its targeted mechanism and clinical benefits.

3. What are the biggest regulatory hurdles for VUSION’s global expansion?

Key challenges include obtaining label expansions, demonstrating cost-effectiveness for reimbursement, and alleviating off-label use concerns. Differing regional policies also influence approval timelines.

4. How sensitive is VUSION’s revenue to market penetration?

Highly sensitive. A 1-2% variation in early adoption rates can significantly impact total revenues, emphasizing the importance of market access strategies.

5. What is the outlook for VUSION’s pipeline and indication expansion?

Pending positive Phase III outcomes, VUSION could expand into first-line settings, other solid tumors with EGFR/MET involvement, and potentially receive orphan drug designations, further boosting its market and revenue potential.

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Sources

[1] Global Cancer Statistics 2022. International Agency for Research on Cancer (IARC).
[2] Hirsch, F., et al. (2017). "Epidemiology of lung cancer." Lung Cancer Journal.
[3] Camidge, D. R., et al. (2017). "MET amplification and resistance to EGFR inhibitors." Clinical Cancer Research.
[4] Research and Markets. (2022). "Oncology Drug Market Forecast 2022-2027."