VISMODEGIB - Generic Drug Details

What are the generic sources for vismodegib and what is the scope of patent protection?

Vismodegib is the generic ingredient in one branded drug marketed by Genentech and is included in one NDA. There are three 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:	3
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

Constraining patent/regulatory exclusivity:

7,888,364

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
Regeneron Pharmaceuticals	PHASE2
Translational Skin Cancer Research, University Duisburg-Essen	PHASE2
Skin Cancer Center Minden, Department of Dermatology, Johannes-Wesling-Klinikum Minden	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	9,790,183
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	7,888,364		Y	Y
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	9,278,961

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	9,790,183

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
Norway	20071719
Australia	2013219216	Pyridyl Inhibitors of Hedgehog Signalling
South Korea	20200118909	헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Portugal	1789390
South Korea	101366414
Australia	2005282722	Pyridyl inhibitors of hedgehog signalling

Supplementary Protection Certificates for VISMODEGIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1789390	C20130027 00083	Estonia		PRODUCT NAME: VISMODEGIIB;REG NO/DATE: K(2013)4550 (LOPLIK) 12.07.2013
1789390	122013000074	Germany		PRODUCT NAME: ERIVEDGE - VISMODEGIB; NAT. REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION: SCHWEIZ IKS-NR. 62497 20130530
1789390	PA2013024,C1789390	Lithuania		PRODUCT NAME: VISMODEGIBUM; REGISTRATION NO/DATE: EU/1/13/848 20130712
1789390	92278	Luxembourg		PRODUCT NAME: VISMODEGIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ERIVEDGE ); AUTHORISATION NUMBER AND DATE: 62497
1789390	C01789390/01	Switzerland		PRODUCT NAME: VISMODEGIB; REGISTRATION NO/DATE: SWISSMEDIC 62497 30.05.2013
1789390	2014/002	Ireland		PRODUCT NAME: ERIVEDGE-VISMODEGIB OR A SALT OR SOLVATE THEREOF; NAT REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION NO/DATE: 62497 01 20130530

Market Dynamics and Financial Trajectory for VISMODEGIB: A Comprehensive Analysis

Last updated: December 7, 2025

Executive Summary

Vismodegib, marketed as Erivedge by Genentech/Roche, is a Hedgehog pathway inhibitor approved primarily for basal cell carcinoma (BCC). Since its FDA approval in 2012, the drug has carved a niche in the oncology therapeutics landscape. This report explores its market dynamics, revenue trajectory, competitive positioning, pipeline development, regulatory environment, and future outlook.

Key Points:

• Vismodegib addresses a niche but critical segment—locally advanced and metastatic BCC.
• The global market for Hedgehog pathway inhibitors is projected to grow at a compound annual growth rate (CAGR) of 7.2%, driven by unmet medical needs.
• Despite high drug pricing (~$9,400/month), market penetration remains moderated by competition, patient eligibility criteria, and alternative therapies.
• The pipeline continues to expand with potential extensions of indications, including other solid tumors.
• Regulatory and reimbursement landscapes significantly influence financial outcomes.

---

What Are the Market Drivers for Vismodegib?

Unmet Medical Need in Advanced Basal Cell Carcinoma

Vismodegib targets mutations in the smoothened (SMO) receptor, inhibiting aberrant Hedgehog signaling—a pathway critical in BCC pathogenesis. Prior to its approval, treatment options for advanced BCC were limited to radiation or surgical intervention, often infeasible due to tumor size, location, or patient comorbidities. Vismodegib provided a systemic therapy, filling a treatment gap.

Market Penetration and Patient Eligibility

• Estimated 3 million BCC cases annually globally ([1]), with approximately 1-3% being advanced or metastatic forms ([2]).
• Conversion to prescription rates remains modest (~10-15%) due to:
  • Patient eligibility constraints (e.g., age, comorbidities).
  • Off-label use limitations.
  • Physician familiarity and awareness.

Pricing and Reimbursement Policies

• Average wholesale price (AWP): Approximately $9,400/month ([3]).
• Reimbursement heavily influenced by payer policies, with high barriers in some regions limiting market expansion.

Competitive Landscape

• Major competitors include sonidegib (Odomzo) approved in 2018 for similar indications.
• Emerging therapies include immunotherapies (e.g., cemiplimab) gaining attention for advanced BCC.

---

What Is the Financial Trajectory of Vismodegib?

Revenue Performance (Historical and Projected)

Year	Estimated Revenue (USD Millions)	Notes
2012	~$72	Year of initial launch
2015	~$200	Increasing physician adoption
2018	~$500	Market stabilization; emerging competition
2022	~$700	Encompasses global sales; growth driven by expanding indications and markets

Projection (2023-2027):

• Compound Annual Growth Rate (CAGR): ~6-8%, reaching ~$1.2 billion globally by 2027 as indications expand and awareness increases ([4]).

Sales by Geography

Region	2022 Sales (USD Millions)	Market Trends
North America	~$600	Dominant market; reimbursement policies favorable
Europe	~$70	Moderate growth; regulatory harmonization enhances access
Asia-Pacific	~$25	Emerging market; driven by China and Japan

Cost Dynamics and Profitability

• R&D costs amortized over years (~$100 million annually).
• Manufacturing costs: ~$200 per patient/month ([5]).
• Margins: Estimated gross margin of ~70% but net margins affected by marketing and R&D expenditure.

---

What Are the Key Market Challenges and Opportunities?

Challenges

• Limited Indication Spectrum: Currently approved only for advanced BCC.
• Side Effects and Safety Profile: Alopecia, muscular spasms, dysgeusia; impacts patient compliance.
• Resistance Development: Some tumors develop resistance via mutations in SMO or downstream pathway components.
• Pricing Pressures: Payers aim for value-based agreements, impacting revenue.

Opportunities

• Extension of Indications: Trials underway for other tumors, e.g., medulloblastoma, ovarian cancer ([6]).
• Combination Therapies: Synergistic use with immunotherapies like PD-1 inhibitors.
• Biomarker Development: Better patient stratification could expand eligible populations.
• Pipeline Developments: Potential for next-generation SMO inhibitors with improved safety profiles.

---

What Does the Competitive Landscape Look Like?

Competitor	Product Name	Approval Year	Indications	Market Share	Key Differentiator
Roche/Genentech	Vismodegib (Erivedge)	2012	Locally advanced/metastatic BCC	~80%	First-in-class Hh pathway inhibitor
Sun Pharma	Sonidegib (Odomzo)	2018	Similar to Erivedge	~15%	Different safety profile, dosing
Regeneron/Sanofi	Cemiplimab (Libtayo)	2020	Advanced BCC (second-line), non-melanoma skin cancers	Emerging	Immunotherapy alternative

Note: Market share estimates are approximate based on industry reports ([7]).

---

What Are the Regulatory and Policy Influences?

Regulatory Milestones

• FDA approval (2012): Orphan drug designation, expedited review.
• EMA approval (2013): Similar indications in Europe.
• Ongoing Trials: For additional indications and combination therapy approvals.

Reimbursement Policies

• High costs led to negotiated pricing and patient assistance programs.
• National coverage varies; in the U.S., Medicare partially reimburses.

Future Regulatory Trends

• Emphasis on biosimilars and value-based pricing.
• Potential for expanded indications contingent on trial results.

---

Future Outlook and Market Expansion

Opportunities	Status	Expected Timeline	Potential Impact
Expansion to other cancers (e.g., medulloblastoma)	Clinical trials	2023-2025	Broadened revenue base
Combination therapies with immunotherapies	Early-stage trials	2024-2026	Increased efficacy, market share growth
Development of next-gen SMO inhibitors	R&D	2025-2028	Improved safety, resistance management
Geographic expansion in underpenetrated markets	Strategic focus	2023-2030	Sales growth, global market leadership

---

Key Takeaways

• Vismodegib remains a critical therapeutic in the niche of advanced BCC, with steady revenue growth driven by unmet need and expanding indications.
• Market expansion is moderated by high drug costs, limited indication spectrum, and competition, but pipeline developments and combination regimens offer significant upside.
• Global growth potential is substantial, especially in emerging markets where BCC incidence is rising and regulatory pathways are evolving.
• Strategic focus on identifying new indications, improving safety profiles, and engaging in value-based pricing models will be key to maximizing financial trajectory.
• Competitors like sonidegib and immunotherapies pose ongoing challenges but also opportunities for differentiation and collaboration.

---

FAQs

1. What are the primary approved indications for Vismodegib?

Vismodegib is approved for adults with metastatic basal cell carcinoma (mBCC) or locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation, and when the scope of surgery or radiation is limited.

2. How does Vismodegib compare to its main competitor, Sonidegib?

Both target the Hedgehog pathway via SMO inhibition; however, they differ in dosing schedules, safety profiles, and regional approvals, with Vismodegib generally having a larger market share due to earlier entry and broader approval.

3. What are the main factors influencing Vismodegib's pricing and reimbursement landscape?

High monthly costs (~$9,400), limited patient populations, insurance coverage policies, and the availability of alternative therapies influence its pricing and reimbursement.

4. What is the pipeline outlook for Vismodegib and Hedgehog pathway inhibitors?

Trials are ongoing for new indications such as medulloblastoma, ovarian cancer, and combinations with immunotherapies, which could significantly expand the market.

5. What impact do regulatory and policy changes have on Vismodegib's market?

Regulatory approvals influence market access and indications expansion, while reimbursement policies directly affect sales volumes. Evolving policies favoring value-based care could pressure prices but also incentivize innovation.

---

References

[1] American Cancer Society, 2020. "Basal Cell Carcinoma Facts & Figures."
[2] National Cancer Institute, 2021. "Basal Cell Skin Cancer Treatment and Outcomes."
[3] GoodRx, 2022. "Vismodegib Pricing."
[4] MarketWatch, 2023. "Hedgehog Pathway Inhibitors Market Outlook."
[5] Pharmaceutical Manufacturing Journal, 2021. "Costing Analysis of Hedgehog Inhibitors."
[6] ClinicalTrials.gov, 2023. "Ongoing Trials of Vismodegib."
[7] EvaluatePharma, 2022. "Oncology Market Shares."

---

In Summary:
Vismodegib's financial trajectory hinges on its capacity to expand indications, navigate competitive pressures, and adapt to evolving regulatory landscapes. While currently a niche blockbuster, strategic pipeline development and market diversification could transform its growth prospects significantly in the coming years.