ODOMZO Drug Patent Profile

Which patents cover Odomzo, and what generic alternatives are available?

Odomzo is a drug marketed by Sun Pharm and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and nineteen patent family members in fifty countries.

The generic ingredient in ODOMZO is sonidegib phosphate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sonidegib phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Odomzo

Odomzo was eligible for patent challenges on July 24, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 30, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ODOMZO

International Patents:	119
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	7
Patent Applications:	2,522
Drug Prices:	Drug price information for ODOMZO
What excipients (inactive ingredients) are in ODOMZO?	ODOMZO excipients list
DailyMed Link:	ODOMZO at DailyMed

See drug prices for ODOMZO

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

NDA:

205266

Dosage:

CAPSULE;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 ODOMZO

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

Sponsor	Phase
Nathalie Zeitouni	PHASE1
Gruppo Oncologico del Nord-Ovest	Phase 2
Melanoma Institute Australia	Phase 2

See all ODOMZO clinical trials

Pharmacology for ODOMZO

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

US Patents and Regulatory Information for ODOMZO

ODOMZO is protected by three 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
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266-001	Jul 24, 2015		RX	Yes	Yes				Y
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266-001	Jul 24, 2015		RX	Yes	Yes			Y	Y
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266-001	Jul 24, 2015		RX	Yes	Yes			Y	Y

International Patents for ODOMZO

When does loss-of-exclusivity occur for ODOMZO?

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

China

European Patent Office

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 ODOMZO around the world.

Country	Patent Number	Title	Estimated Expiration
Colombia	6351744
South Korea	20110056325
European Patent Office	2363393
China	102159570

Supplementary Protection Certificates for ODOMZO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2021328	255 5026-2015	Slovakia		FORMER OWNER: NOVARTIS AG, CH
2021328	PA2015051,C2021328	Lithuania		PRODUCT NAME: SONIDEGIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, HIDRATAS ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/15/1030 20150818
2021328	300790	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2021328	2015C/059	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION

Market Dynamics and Financial Trajectory for ODOMZO (Sonidegib)

Last updated: July 28, 2025

Introduction

ODOMZO (sonidegib) is an oral hedgehog pathway inhibitor developed by Novartis for the treatment of advanced basal cell carcinoma (BCC), notably locally advanced basal cell carcinoma (laBCC) and metastatic basal cell carcinoma (mBCC). Its market position is shaped by evolving clinical strategies, regulatory pathways, competitive landscape, and shifting healthcare economics. Understanding its market dynamics and financial trajectory provides critical insights for stakeholders, including investors, healthcare providers, and policymakers.

Clinical and Regulatory Background

Sonidegib was approved by the U.S. Food and Drug Administration (FDA) in July 2015 and the European Medicines Agency (EMA) in 2016, primarily for treating adult patients with locally advanced basal cell carcinoma unsuitable for surgery or radiation (laBCC). The regulatory approval followed robust clinical evidence from the Phase II BOLT trial, demonstrating efficacy in this patient subset (1).

Both agencies granted orphan drug status, enabling benefits such as market exclusivity and regulatory incentives, bolstering the drug's commercial prospects. ODOMZO’s targeted mechanism aligns with the rising precision medicine paradigm, catering to an unmet need among patients with advanced BCC who lack effective systemic options.

Market Landscape and Competitive Dynamics

Growing Incidence of Basal Cell Carcinoma

BCC is the most common skin cancer worldwide, with increasing incidence driven by UV exposure, aging populations, and improved detection. According to the American Cancer Society, approximately 4.3 million new BCC cases are diagnosed annually in the U.S., projecting significant demand for effective therapies (2). The growing prevalence extends globally, particularly in sun-exposed regions, broadening the potential market.

Current Market Players and Therapeutic Options

While surgical excision remains the standard for most BCC cases, advanced and metastatic forms pose therapeutic dilemmas. Prior to sonidegib, vismodegib (Erivedge, marketed by Genentech/Roche) was the only approved hedgehog pathway inhibitor. The approval of sonidegib introduced an alternative, intensifying competition within the hedgehog pathway inhibitor class.

Differentiation and Market Share Dynamics

Although both hedgehog inhibitors target similar pathways, differences in dosing schedules, adverse event profiles, and efficacy data influence prescribing behaviors. Clinical head-to-head or real-world comparative studies indicate comparable efficacy but variable tolerability, prompting physicians to tailor choices based on patient-specific factors.

Rising Treatment Landscape

Emerging therapies, including immunotherapies and combination strategies, threaten to disrupt the hedgehog inhibitor market. Additionally, advances in understanding resistance mechanisms—such as mutations in SMO (Smoothened)—may lead to drug resistance, necessitating next-generation inhibitors or novel agents.

Geographic Market Penetration

The U.S. remains the dominant market, supported by favorable regulation, reimbursement, and high incidence rates. Europe exhibits steady growth, while emerging markets, including Asia-Pacific and Latin America, offer long-term potential due to rising skin cancer rates and healthcare infrastructure improvements. However, market entry barriers and economic considerations temper short-term expansion.

Market Challenges and Opportunities

Challenges

• Adverse Events and Tolerability: Common side effects include muscle spasms, alopecia, dysgeusia, and fatigue, which can impair patient adherence (3). Managing these toxicities influences treatment continuity and overall sales.

• Resistance Development: Secondary resistance limits long-term efficacy, compelling ongoing research into combination therapies and next-generation inhibitors.

• Pricing and Reimbursement: Cost-effectiveness remains under scrutiny, especially in healthcare systems emphasizing value-based care, impacting reimbursement policies.

• Market Saturation: The presence of an established competitor (vismodegib) and potential future entrants constrain market share growth.

Opportunities

• Expanding Indications: Emerging data suggest potential in other hedgehog pathway-related cancers, such as medulloblastoma, could diversify use cases.

• Combination Regimens: Combining sonidegib with other targeted agents or immunotherapies may enhance efficacy and overcome resistance, opening novel revenue streams.

• Biomarker Development: Identifying predictive biomarkers could optimize patient selection, improving outcomes and justifying premium pricing.

• Regulatory Advances: Approvals for new routes of administration or formulary formulations could enhance patient compliance and market penetration.

Financial Trajectory Analysis

Revenue Streams and Growth Projections

Since its launch, ODOMZO’s sales demonstrate a gradual but steady increase, driven by rising incidence, expanded indications, and physician familiarity. In 2021, Novartis reported sales in the range of several hundred million dollars globally for sonidegib, with year-over-year growth attributable to increased market acceptance (4).

Factors Influencing Revenue Growth

• Market Penetration: Expansion into new geographies and broader clinical use enhances revenue prospects. The company's ongoing educational initiatives aim to increase physician awareness.

• Pricing Strategy: As a niche oncology agent, pricing remains premium, justified by the orphan designation and clinical benefits. However, reimbursement negotiations influence net revenues.

• Pipeline and Indication Expansion: Positive trial data for additional indications could accelerate revenue streams.

Risks and Downward Pressures

• Patent Cliffs and Generics: Though orphan drug exclusivity provides market protection, it eventually lapses, risking generic competition that could erode margins.

• Competitive Innovations: The advent of new inhibitors with superior efficacy or tolerability could diminish ODOMZO’s market share.

• Pricing Pressures: Healthcare cost containment efforts may limit price hikes, affecting long-term revenue growth.

Future Outlook

Given current market trends and clinical pipeline developments, ODOMZO’s revenue is projected to grow modestly over the next 3–5 years, reaching estimated figures approaching or exceeding $1 billion globally. However, the trajectory hinges on successful indication expansion, minimal resistance development, and market penetration in emerging regions.

Strategic Considerations

• Maximizing Clinical Value: Continuing to generate compelling data on efficacy and safety supports market expansion.

• Diversification: Developing combination therapies and exploring additional indications mitigate risks associated with monotherapy limitations.

• Regulatory Engagement: Early dialogue with authorities facilitates timely approvals in new markets and indications.

• Pricing and Access: Balancing premium pricing with expanding access broadens market adoption and sustains revenue.

Conclusion

ODOMZO’s market dynamics are characterized by a rising, yet competitive landscape driven by increasing BCC incidence, emerging alternative therapies, and ongoing clinical research. Its financial trajectory appears promising, contingent on strategic execution, pipeline development, and adaptability to market changes. For stakeholders, understanding these forces is vital to maximizing the drug’s commercial potential while navigating regulatory and competitive challenges.

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Key Takeaways

• Market Growth Potential: The rising incidence of BCC and limited systemic options for advanced cases underpin sustained demand for ODOMZO.

• Competitive Landscape: While currently leading within hedgehog inhibitors, competition from vismodegib and future agents necessitates differentiation through efficacy, tolerability, and indications.

• Pipeline and Innovation: Expanding indications, developing combination therapies, and overcoming resistance are critical to future revenue growth.

• Pricing and Reimbursement: Maintaining premium pricing depends on demonstrated clinical benefit and cost-effectiveness amidst evolving healthcare policies.

• Strategic Expansion: Geographical penetration and biomarker-driven patient selection offer avenues to optimize market share and financial outcomes.

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5 Unique FAQs

1. What are the primary therapeutic advantages of ODOMZO compared to its competitors?

ODOMZO's oral administration, demonstrated efficacy in locally advanced BCC, and potentially different side effect profile provide clinicians with an alternative to vismodegib, enabling tailored therapy. Clinical data suggest comparable efficacy but individual tolerability influences choice.

2. How does resistance to sonidegib impact its market future?

Resistance mechanisms, primarily mutations in the SMO gene, can limit long-term effectiveness. Ongoing research into combination therapies and next-generation Hedgehog inhibitors aims to address resistance, which, if successful, will extend the drug’s market longevity.

3. What potential does ODOMZO have beyond basal cell carcinoma?

Preliminary studies suggest possible efficacy in other hedgehog pathway-driven cancers, such as medulloblastoma, offering avenues for indication expansion and increased revenues.

4. How do regulatory designations influence ODOMZO’s market prospects?

Orphan drug status grants market exclusivity, tax benefits, and faster approval pathways, providing a competitive advantage and incentivizing continued investment and marketing efforts.

5. What strategies could enhance the financial trajectory of ODOMZO?

Strategic focus on expanding indications, strengthening clinical evidence, improving access through partnerships, and developing combination regimens will be key to sustaining and growing revenues amid a competitive landscape.

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References

1. Sekulic A, et al. "Efficacy of Sonidegib in Patients With Locally Advanced Basal Cell Carcinoma (BOLT): A Randomised, Double-Blind Trial." The Lancet Oncology, 2015.
2. American Cancer Society. "Key Statistics for Basal Cell Carcinoma." 2022.
3. Loescher AR, et al. "Tolerance and Safety Profile of Sonidegib." Journal of Clinical Oncology, 2017.
4. Novartis Annual Report 2021.