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 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:	77
Patent Applications:	3,554
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
Sun Pharmaceutical Industries Limited	Phase 2
H. Lee Moffitt Cancer Center and Research Institute	Early Phase 1
Genentech, Inc.	Early Phase 1

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

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	9,278,961
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	9,790,183

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/002602 Erivedge 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
Australia	2021205133	Pyridyl inhibitors of hedgehog signalling
Spain	2377430
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
Norway	339260
Denmark	1789390
Australia	2017261491	Pyridyl Inhibitors of Hedgehog Signalling

Supplementary Protection Certificates for vismodegib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1789390	14C0002	France		PRODUCT NAME: VISMODEGIB AINSI QUE SES SELS ET SOLVATES; NAT. REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION: IKS 62497 20130530
1789390	C 2013 038	Romania		PRODUCT NAME: VISMODEGIB SI SARURILE SI SOLVATIIACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/848; DATE OF NATIONAL AUTHORISATION: 20130712; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 62497 01; DATE OF FIRST AUTHORISATION IN EEA: 20130530
1789390	PA2013024	Lithuania		PRODUCT NAME: VISMODEGIBUM; NAT. REGISTRATION NO/DATE: SWISS 62497 01 20130530; FIRST REGISTRATION: EU/1/13/848 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	170 12-2013	Slovakia		PRODUCT NAME: VISMODEGIB; REGISTRATION NO/DATE: EU/1/13/848/001 20130712
1789390	514	Finland

Vismodegib Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vismodegib

Introduction to Vismodegib

Vismodegib, marketed under the brand name Erivedge, is a Hedgehog pathway inhibitor that has emerged as a significant therapeutic option for treating various forms of skin cancer, particularly basal cell carcinoma (BCC).

Market Size and Growth

The global hedgehog pathway inhibitors market, which includes vismodegib, is projected to experience substantial growth. As of 2022, the market size was valued at USD 603.98 million and is expected to reach USD 1545 million by 2031, registering a Compound Annual Growth Rate (CAGR) of 11% during the forecast period of 2023-2031[1].

Key Drivers of Market Growth

Several factors are driving the growth of the vismodegib market:

• Increasing Incidence of Skin Cancer: The rising incidence of skin cancer, including basal cell carcinoma, due to factors such as pollution, global warming, and exposure to UV radiation, is a major driver[1].
• Growing Awareness and Need for Targeted Therapies: The increasing awareness of the risks associated with acute myeloid leukemia (AML) and basal cell carcinoma (BCC), along with the need for painless or minimally invasive treatments, is boosting demand for vismodegib[1].
• Advancements in Treatment Techniques: The development of user-friendly cancer treatment techniques and funding from governmental and non-governmental organizations to promote innovation in cancer treatment are also contributing to market growth[1].

Regional Market Analysis

North America

North America, particularly the United States and Canada, is a prominent player in the global pharmaceutical market for vismodegib. The region has a strong healthcare infrastructure, advanced research facilities, and a significant patient population, making it an important market for oncology medicines. North America is expected to grow at a CAGR of 4% over the forecast period[1].

Asia Pacific

The Asia Pacific region is identified as the fastest-growing market for hedgehog pathway inhibitors, including vismodegib. This growth is driven by increasing healthcare expenditure, improving healthcare infrastructure, and a rising incidence of skin cancer in the region[1].

Clinical Efficacy and Applications

Basal Cell Carcinoma (BCC)

Vismodegib has shown significant efficacy in treating locally advanced and metastatic BCC. In the pivotal phase 2 ERIVANCE BCC trial, the objective response rate was 48.5% for metastatic BCC and 43% for locally advanced BCC[4].

• Neoadjuvant Treatment: Studies have demonstrated that vismodegib can be effective in the neoadjuvant setting, allowing for downstaging of surgical procedures for locally advanced BCC, especially in functionally sensitive locations. For example, the VISMONEO clinical trial showed that 80% of patients were eligible for downstaging surgery after vismodegib treatment[2].

Other Potential Applications

Research is ongoing to expand the indications for vismodegib beyond its initial approved applications. For instance, clinical trials are investigating the use of vismodegib in combination with chemotherapy for pancreatic cancer, showing potential for illness control and overall survival[1].

Side Effects and Tolerability

While vismodegib has a favorable response profile, it is associated with several side effects, including muscle cramps, dysgeusia (taste disturbances), weight loss, and alopecia. Despite these side effects, the treatment has been found to improve health-related quality of life for patients with periocular BCC[4].

Market Competition and Strategic Alliances

The skin cancer drugs market, including vismodegib, is highly competitive with major players such as Novartis AG, Bristol Myers Squibb, Eli Lilly, and Roche. Companies are increasingly seeking strategic alliances to enhance their research and development capabilities and expedite the development of new drugs[3].

Financial Projections

The global skin cancer drugs market, which includes vismodegib, is expected to grow from $3.03 billion in 2022 to $3.41 billion in 2023 at a CAGR of 12.7%. By 2027, the market is projected to reach $5.23 billion, driven by the increasing prevalence of skin cancer and the demand for targeted therapies[3].

Key Takeaways

• Vismodegib is a critical component of the growing hedgehog pathway inhibitors market.
• The market is driven by increasing skin cancer incidence, advancements in treatment techniques, and strong healthcare infrastructure in regions like North America.
• Vismodegib has shown significant efficacy in treating BCC and is being explored for other cancer types.
• Despite side effects, the drug improves quality of life for patients.
• Strategic alliances and continuous R&D are key strategies in the competitive skin cancer drugs market.

FAQs

What is the primary use of vismodegib?

Vismodegib is primarily used to treat basal cell carcinoma (BCC), particularly in cases where the cancer is locally advanced or metastatic[4].

What are the common side effects of vismodegib?

Common side effects of vismodegib include muscle cramps, dysgeusia (taste disturbances), weight loss, and alopecia[4].

How effective is vismodegib in treating BCC?

Vismodegib has shown a response rate of 48.5% for metastatic BCC and 43% for locally advanced BCC in clinical trials[4].

Is vismodegib used in combination with other treatments?

Yes, vismodegib is being studied in combination with chemotherapy for other types of cancer, such as pancreatic cancer, to improve treatment outcomes[1].

What is the projected market growth for vismodegib and related drugs?

The global hedgehog pathway inhibitors market, including vismodegib, is projected to grow from USD 603.98 million in 2022 to USD 1545 million by 2031, with a CAGR of 11%[1].

Cited Sources:

1. Straits Research: Hedgehog Pathway Inhibitors Market Size, Share & Trends Analysis Report.
2. The Lancet: Vismodegib in neoadjuvant treatment of locally advanced basal cell carcinoma.
3. PR Newswire: Skin Cancer Drugs Global Market Research Report 2023.
4. ScienceDirect: Exploring vismodegib: A non-surgical breakthrough in the treatment of basal cell carcinoma.