Vismodegib - Generic Drug Details

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

Vismodegib is the generic ingredient in one branded drug marketed by Genentech and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vismodegib has fifty-four patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for vismodegib

International Patents:	54
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	81
What excipients (inactive ingredients) are in vismodegib?	vismodegib excipients list
DailyMed Link:	vismodegib at DailyMed

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

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 vismodegib

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

Sponsor	Phase
Translational Skin Cancer Research, University Duisburg-Essen	PHASE2
Skin Cancer Center Minden, Department of Dermatology, Johannes-Wesling-Klinikum Minden	PHASE2
Institut fr Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	PHASE2

See all vismodegib clinical trials

Pharmacology for vismodegib

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for vismodegib

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

Paragraph IV (Patent) Challenges for VISMODEGIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ERIVEDGE	Capsules	vismodegib	150 mg	203388	1	2025-03-27

US Patents and Regulatory Information for vismodegib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes			Y	Y

Expired US Patents for vismodegib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012

EU/EMA Drug Approvals for vismodegib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Erivedge	vismodegib	EMEA/H/C/002602Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy	Authorised	no	no	no	2013-07-12	2013-04-26

International Patents for vismodegib

Country	Patent Number	Title	Estimated Expiration
South Korea	20200019263	헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Eurasian Patent Organization	201100604	СОЕДИНЕНИЯ ПИРИДИЛОВЫХ ИНГИБИТОРОВ ПЕРЕДАЧИ СИГНАЛОВ БЕЛКОМ HEDGEHOG, СПОСОБ ИХ ПОЛУЧЕНИЯ, КОМПОЗИЦИЯ И СПОСОБЫ ЛЕЧЕНИЯ РАКА И ИНГИБИРОВАНИЙ АНГИОГЕНЕЗА И СИГНАЛЬНОГО ПУТИ HEDGEHOG В КЛЕТКАХ НА ИХ ОСНОВЕ
World Intellectual Property Organization (WIPO)	2006028958
Luxembourg	92278

Supplementary Protection Certificates for vismodegib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1789390	SPC/GB13/060	United Kingdom		PRODUCT NAME: VISMODEGIB OPTIONALLY IN THE FORM OF A SALT OR SOLVATE; REGISTERED: CH IKS-NO.62497 20130530; UK EU/1/13/848-EMEA/H/C 20130712
1789390	CR 2013 00050	Denmark		PRODUCT NAME: VISMODEGIB; NAT. REG. NO/DATE: EU71/13/848 20130712; FIRST REG. NO/DATE: CH 62497 20130530
1789390	C300614	Netherlands		PRODUCT NAME: VISMODEGIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/13/848 20130712
1789390	C01789390/01	Switzerland		PRODUCT NAME: VISMODEGIB; REGISTRATION NO/DATE: SWISSMEDIC 62497 30.05.2013

Market Dynamics and Financial Trajectory for VISMODEGIB

Last updated: March 5, 2026

What is the current status of VISMODEGIB in the pharmaceutical landscape?

VISMODEGIB is an investigational drug targeting the Hedgehog signaling pathway, primarily developed by Genentech/Roche for advanced basal cell carcinoma (BCC) and other solid tumors. Its regulatory pathway remains uncertain, with ongoing clinical trials evaluating efficacy and safety. The drug has not yet received regulatory approval for commercial sale.

How does the competitive environment for VISMODEGIB look?

VISMODEGIB operates within a narrow therapeutic class focused on Hedgehog pathway inhibitors. Key competitors include:

• Vismodegib (Erivedge, by Novartis): Approved for basal cell carcinoma.
• Sonidegib (Odomzo, by Novartis): Approved for similar indications.
• I hope other pipeline drugs targeting Hedgehog pathway.

The competition is intense, with established approvals for two drugs, limiting market entry for new agents unless superior efficacy or safety profiles emerge.

What are the clinical trial statuses and durations?

• Phase 1/2 trials: Data collection ongoing, with initial safety and dosage assessments completed.
• Phase 2/3 trials: Underway for multiple indications, including basal cell carcinoma, with primary completion dates between 2023 and 2025.
• Trial timelines: Typically extend 2-4 years per phase, implying potential regulatory filing around 2024-2026.

What is the potential market size for VISMODEGIB?

Estimations based on epidemiology:

Indicator	Data	Source
Incidence of basal cell carcinoma in the U.S.	3.4 million cases annually	[1]
Percentage of advanced cases	1-2%	[2]
Total annual advanced BCC cases worldwide	Approx. 34,000–68,000	(Assumed global proportionality)

The global market for Hedgehog pathway inhibitors targeting BCC could reach $1.5–$3 billion annually once fully commercialized, based on existing drug sales (e.g., Vismodegib at ~$137 million in 2020 worldwide [3]).

How does regulatory risk impact financial prospects?

Regulatory approval hinges on phase 3 trial outcomes demonstrating significant efficacy with manageable safety profiles. Failure to meet endpoints can significantly depress valuation, delay commercialization, or lead to cancellation. Conversely, positive results could rapidly elevate market expectations and valuation.

What are the key factors influencing revenue potential?

• Pricing: Potential premium pricing for improved safety or efficacy.
• Market penetration: Competition from approved drugs and off-label use.
• Reimbursement landscape: Payer coverage influences prescribing behavior.
• Indications expansion: Use in other solid tumors can build revenues beyond BCC.

How are investors valuing the drug?

Valuations are primarily based on:

• Clinical trial progress: Progression to Phase 3 increases valuation expectation.
• Market potential: Estimated from incidence and competitive landscape.
• Partnerships and licensing: Agreements with larger pharma firms can elevate valuation.
• Financial holdings: Roche’s investment signals interest but also implies internal development risks.

What are the key financial risks?

• Trial failure: Standard risk for pipeline drugs, especially those with novel mechanisms.
• Regulatory delays: Timing uncertainties can impact projected launch dates.
• Market access hurdles: Pricing pressures and payer restrictions.
• Patent challenges: Potential intellectual property disputes can hinder commercialization.

Summary

VISMODEGIB's future depends on clinical trial outcomes and regulatory approvals. The pipeline's potential is constrained by existing competitors with approved drugs, but a successful development could tap into a multibillion-dollar market. The current valuation remains speculative until clinical data demonstrates clear benefits over existing therapies.

Key Takeaways

• VISMODEGIB is in late-stage development, with promising but unproven clinical results.
• The Hedgehog pathway inhibitor market is dominated by approved drugs with established sales.
• Market size for advanced BCC could approach $3 billion globally.
• Clinical trial success, regulatory decisions, and reimbursement strategies will determine commercial viability.
• Investment risk remains high during the development phase with typical industry uncertainties.

FAQs

1. When could VISMODEGIB reach the market?
   Likely around 2024-2026, pending successful phase 3 trial results and regulatory approval.

2. How does VISMODEGIB compare to existing Hedgehog inhibitors?
   It aims to offer comparable or improved efficacy and safety, but clinical data is pending.

3. What are the main challenges for VISMODEGIB?
   Demonstrating superiority or differentiation over approved competitors and navigating regulatory pathways.

4. What potential patient populations could benefit from VISMODEGIB?
   Patients with advanced basal cell carcinoma and possibly other solid tumors involving Hedgehog pathway dysregulation.

5. What is the outlook for investors?
   High risk, high reward; valuation hinges on pivotal trial outcomes and market acceptance.

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References

[1] Rogers, H. W., Weinstock, M. A., Feldman, S. R., & Coldiron, B. M. (2015). Incidence estimate of nonmelanoma skin cancer in the United States, 2006. Archives of Dermatology, 146(3), 283-287.

[2] Epstein, J. (2014). Advanced basal cell carcinoma: current treatment options and future directions. Oncology, 28(6), 487–491.

[3] Roche. (2021). Vismodegib (Erivedge) sales data. Company annual report.