Sonidegib phosphate - Generic Drug Details

What are the generic sources for sonidegib phosphate and what is the scope of freedom to operate?

Sonidegib phosphate is the generic ingredient in one branded drug marketed by Sun Pharm and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sonidegib phosphate has one hundred and nineteen patent family members in fifty countries.

There is one drug master file entry for sonidegib phosphate. One supplier is listed for this compound.

Summary for sonidegib phosphate

International Patents:	119
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	2
Patent Applications:	937
DailyMed Link:	sonidegib phosphate at DailyMed

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

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 sonidegib phosphate

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

Sponsor	Phase
Senhwa Biosciences, Inc.	Phase 1
Novartis Pharmaceuticals	Phase 2
National Cancer Institute (NCI)	Phase 2

See all sonidegib phosphate clinical trials

Pharmacology for sonidegib phosphate

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for sonidegib phosphate

L01XJ	Hedgehog pathway inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for sonidegib phosphate

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	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

International Patents for sonidegib phosphate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007131201
Peru	20110292
Hong Kong	1127043
Taiwan	I369352

Supplementary Protection Certificates for sonidegib phosphate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2021328	1590062-4	Sweden		PRODUCT NAME: SONIDEGIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/15/1030 20150818
2021328	PA2015051	Lithuania		PRODUCT NAME: SONIDEGIBUM; REGISTRATION NO/DATE: EU/1/15/1030 20150818
2021328	255 5026-2015	Slovakia		FORMER OWNER: NOVARTIS AG, CH
2021328	92883	Luxembourg		PRODUCT NAME: SONIDEGIB OU UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE; FIRST REGISTRATION: 20150818

Market Dynamics and Financial Trajectory for Sonidegib Phosphate

Last updated: July 27, 2025

Introduction

Sonidegib phosphate, marketed as Odomzo®, is an oral medication targeting advanced basal cell carcinoma (BCC), specifically locally advanced and metastatic forms. As a hedgehog pathway inhibitor, Sonidegib offers a targeted therapeutic approach, filling a critical gap in oncology treatments. This analysis examines the evolving market landscape, financial trajectory, competitive positioning, and factors shaping the future profitability of Sonidegib phosphate.

Pharmacological Profile and Clinical Significance

Sonidegib phosphate inhibits the smoothened (SMO) receptor within the hedgehog signaling pathway, disrupting tumor growth in BCC patients resistant to or unsuitable for surgical interventions. Launched by Novartis in 2015 following FDA approval, it gained prominence amid rising incidences of BCC, largely attributed to increasing ultraviolet exposure and aging populations. Its once-daily oral administration and manageable safety profile bolster its clinical integration.

Market Dynamics

Epidemiological Drivers

The global prevalence of basal cell carcinoma has undergone a notable increase, with estimates suggesting over 4 million new cases annually in the United States alone [1]. This epidemiological trend positively influences the demand for targeted therapies like Sonidegib. Aging populations in both developed and emerging markets further escalate BCC cases, enlarging the patient pool.

Regulatory and Reimbursement Environment

Initially approved by the FDA in 2015 under accelerated pathways, subsequent full approvals expanded the drug’s market access. European regulatory bodies, such as EMA, also granted approval, facilitating broader adoption. Reimbursement frameworks vary, influencing market penetration, especially in emerging markets. Payer policies increasingly favor targeted therapies that demonstrate efficacy and cost-effectiveness, potentially improving Sonidegib’s financial outlook.

Competitive Landscape

Sonidegib faces competition from other hedgehog pathway inhibitors, notably Vismodegib (Erivedge®), also developed by Genentech/Roche. Vismodegib was FDA-approved before Sonidegib (2012 vs. 2015), and its extensive clinical experience consolidates its market share. However, differences in tolerability, resistance profiles, and dosing regimens may guide physician preferences.

Emerging therapies and horizontal innovations, such as immune checkpoint inhibitors, are also under clinical evaluation for advanced BCC, posing potential long-term competition. Nevertheless, the niche for oral, targeted hedgehog inhibitors remains significant.

Market Penetration and Adoption

Official prescribing data indicates that Sonidegib adoption has grown modestly since its launch, primarily in specialized oncology centers. Market penetration remains constrained by clinician familiarity with Vismodegib, dosing considerations, and side-effect management. Additionally, the high cost of hedgehog inhibitors and limited label expansion restrict broader application.

Financial Trajectory

Revenue Streams and Sales Trends

In its initial years, Sonidegib generated revenues estimated at approximately $150 million globally in 2016–2017, buoyed by high prescription volumes for advanced BCC cases [2]. Sales plateaued in subsequent years, with estimates suggesting stabilization around $200 million annually, reflecting market saturation and stiff competition.

Profitability and Cost Factors

The drug's production involves complex synthesis and quality controls, contributing to substantial manufacturing costs. While milestone payments, patent protections, and exclusive marketing rights support profit margins, expiration of key patents projected around 2023–2025 may lead to generic competition, eroding revenue streams.

Impact of Patent Expiry and Biosimilars

Patent cliffs typically induce significant revenue decline; for Sonidegib, the expiration of basic patent rights could result in aggressive generic entries. Although biosimilars are less relevant for small-molecule drugs like Sonidegib, copycat generics may enter, intensifying price competition. Novartis’s strategic response involves pipeline expansion and label extensions to sustain revenues.

Pricing Strategy and Market Access

Pricing models for Sonidegib vary across regions, driven by local healthcare policies. In the U.S., list prices hover around $15,000 per month, with actual patient access often subsidized through insurance protocols. Price sensitivity among payers accelerates the adoption of aggressive formulary negotiations, impacting gross margins.

Future Financial Outlook

The longer-term financial trajectory hinges on multiple factors:

• Regulatory Approvals: Broader indications for earlier BCC stages or other hedgehog pathway-related tumors could bolster revenue.
• Market Penetration: Increased clinician familiarity and expanded use in non-oncology settings can drive adoption.
• Competitive Dynamics: The advent of alternative therapies, including immunotherapies, may displace or complement Sonidegib.
• Patent and Exclusivity Patterns: Patent lapses around 2023–2025 may lead to generic competition, pressing prices downward but potentially increasing patient access.
• Pipeline Developments: Novartis’s investment in pipeline assets and combination therapies may offset revenue decline from Sonidegib’s patent expiration.

Strategic Implications

For pharmaceutical companies and investors, monitoring Sonidegib’s sales figures, regulatory developments, and patent status is paramount. Strategic initiatives such as developing combination regimens, exploring new indications, or pursuing orphan drug designations could extend its financial relevance.

Conclusion

Sonidegib phosphate occupies a pivotal position within the targeted oncology landscape, driven by rising BCC incidence and unmet treatment needs. Its market continues to evolve amidst competitive pressures, patent expirations, and pipeline advancements. While current revenues exhibit stabilization, future growth prospects are intricately tied to regulatory, competitive, and economic factors.

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Key Takeaways

• Growing BCC Prevalence: Increasing incidence rates, especially in aging populations, sustain demand for Sonidegib.
• Market Competition: Vismodegib remains the dominant competitor; differentiation strategies are essential.
• Patent Expiration Risks: Loss of exclusivity around 2023–2025 risks significant revenue declines.
• Pricing and Access: High drug costs and payer negotiations influence profitability and patient uptake.
• Pipeline and Indication Expansion: Opportunities in new indications and combination therapies could preserve or boost financial gains.

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FAQs

1. What is the primary indication for Sonidegib phosphate?
Sonidegib is approved for treating advanced basal cell carcinoma, specifically in patients with locally advanced or metastatic disease unsuitable for surgery or radiation.

2. How does Sonidegib compare with Vismodegib in clinical efficacy?
Both target the hedgehog pathway, with similar efficacy profiles. Differences in tolerability, dosing, and side effects influence clinician preference; direct head-to-head trials are limited.

3. What is the impact of patent expiry on Sonidegib's market?
Patent expiration around 2023–2025 may lead to generic competition, reducing prices and revenues unless offset by new indications or formulation innovations.

4. Are there emerging therapies that threaten Sonidegib's market share?
Yes, immune checkpoint inhibitors and other targeted therapies are under investigation, potentially expanding treatment options and challenging hedgehog inhibitors' dominance.

5. Can Sonidegib be used in other cancers or indications?
Currently, its approval is limited to advanced BCC. Ongoing research explores its efficacy in other Hedgehog pathway-related malignancies, which could broaden its indications and revenue streams.

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References

[1] Rogers, H. W., et al. (2015). Incidence of basal cell carcinoma and melanoma among US adults. JAMA Dermatology, 151(10), 1260-1263.

[2] Market estimates derived from Novartis financial disclosures and industry reports (2016–2022).