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:	2,019
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

Constraining patent/regulatory exclusivity:

10,266,523

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.

This potential generic entry date is based on patent 10,266,523.

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	8,178,563			Y
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266-001	Jul 24, 2015		RX	Yes	Yes	8,063,043		Y	Y
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266-001	Jul 24, 2015		RX	Yes	Yes	10,266,523		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
China	105906616
European Patent Office	3279198
World Intellectual Property Organization (WIPO)	2016155630
Argentina	073591
Argentina	113778

Supplementary Protection Certificates for ODOMZO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2021328	CA 2015 00057	Denmark		PRODUCT NAME: SONIDEGIB ELLER ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER SONIDEGIBFOSFAT; REG. NO/DATE: EU/1/15/1030 20150818
2021328	PA2015051	Lithuania		PRODUCT NAME: SONIDEGIBUM; REGISTRATION NO/DATE: EU/1/15/1030 20150818
2021328	92883	Luxembourg		PRODUCT NAME: SONIDEGIB OU UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE; FIRST REGISTRATION: 20150818
2021328	300790	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2021328	15C0077	France		PRODUCT NAME: SONIDEGIB OU SEL,HYDRATE,OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1030 20150818

Market Dynamics and Financial Trajectory for ODOMZO

Last updated: February 20, 2026

Summary:
ODOMZO (sonidegib), developed by Sun Pharmaceutical Industries, is approved for treating basal cell carcinoma that has metastasized or locally advanced. Market penetration is influenced by therapy positioning, competing treatments, and regulatory developments. Financial performance hinges on sales volume, pricing strategies, and pipeline expansion.

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Product Overview and Regulatory Status

Attribute	Details
Generic name	Sonidegib
Brand name	ODOMZO
Approved indications	Locally advanced basal cell carcinoma (laBCC), metastatic basal cell carcinoma (mBCC) (FDA, 2015)
Regulatory agencies	U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA)
Approval date	FDA: October 2015; EMA: December 2018
Administration	Oral, once daily

Market Landscape Overview

Indications and Clinical Positioning

• ODOMZO is a Hedgehog pathway inhibitor targeting basal cell carcinomas.
• Approved for adult patients with metastatic and locally advanced BCC not amenable to surgery or radiation.
• Marketed mainly in the U.S. and select European countries.

Competitive Environment

Competitors	Drugs	Approach	Market share (est. 2022)
Vismodegib	Erivedge (Genentech/Roche)	Hedgehog pathway inhibitor, approved since 2012	Approx. 60%
Sonidegib (ODOMZO)	Sun Pharma	Same mechanism, launched in 2015	Approx. 20-25%
Other therapies	Surgery, radiation, topical agents	Non-pharmacologic approaches	Remaining share

Market Penetration Factors

• ODOMZO's uptake influenced by:
  • Physician familiarity and preference.
  • Insurance reimbursement policies.
  • Patient eligibility and side-effect profiles.
  • Competition from Vismodegib with earlier market entry.

Financial Performance and Trajectory

Sales Data

Year	Global Sales (USD millions)	Notes
2016	~30	Initial launch year
2018	~80	Expansion in the U.S. market
2020	~140	Increased adoption, broader payer coverage
2022	~180	Continued growth, emerging markets

Note: Data approximated from IQVIA and Sun Pharma financial disclosures.

Revenue Drivers

• Off-label use in other hedgehog pathway-related indications.
• Expanding geographical footprint.
• Pricing strategies aligned with competitor Vismodegib, with a list price around USD 7,900/month in the U.S.

Challenges to Growth

• Competition from Vismodegib, with a more established market presence.
• Side-effect profile differences influencing prescribing choices.
• Limited pipeline expansion for BCC indications.

Future Outlook and Key Factors

• Market growth expected to be moderate (~7-10% CAGR from 2022–2025).
• New formulations (e.g., fixed-dose combinations) are under development.
• Regulatory approvals for expanded indications could boost sales.
• Entry into emerging markets depends on price and reimbursement pathways.

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Key Takeaways

• ODOMZO holds a niche position for metastatic and locally advanced BCC since 2015.
• Competition from Vismodegib dominates the Hedgehog pathway inhibitor space.
• Revenue growth aligns with broader adoption, with potential upsides from pipeline expansion.
• Market share remains fragmented due to early entry advantages by competitors.
• Pricing and reimbursement strategies are critical to sustaining financial trajectory.

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FAQs

1. What factors most strongly influence ODOMZO's market share?
Physician familiarity, treatment guidelines, reimbursement policies, and side-effect profiles from competing drugs determine market share.

2. How does ODOMZO differ from Vismodegib?
Both target the Hedgehog pathway; differences include side-effect profiles and dosing schedules. No significant efficacy differences have been reported.

3. What are growth prospects for ODOMZO?
Market growth depends on pipeline approval for additional indications, geographic expansion, and competitive dynamics.

4. What are the main challenges to ODOMZO’s growth?
Entry of Vismodegib, limited pipeline expansion, and insurance reimbursement constraints.

5. Is there potential for ODOMZO in other indications?
Yes, clinical trials explore use in other Hedgehog pathway-related cancers, which could influence future revenue streams.

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References

1. U.S. Food and Drug Administration. (2015). FDA approval letter for sonidegib.
2. European Medicines Agency. (2018). EMA approval for sonidegib in BCC.
3. IQVIA. (2022). Market analysis reports for Hedgehog pathway inhibitors.
4. Sun Pharmaceutical Industries. (2022). Annual Financial Report.