VEMURAFENIB - Generic Drug Details

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

Vemurafenib is the generic ingredient in one branded drug marketed by Hoffmann La Roche and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vemurafenib has one hundred and ninety-eight patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for VEMURAFENIB

International Patents:	198
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	149
Patent Applications:	7,190
What excipients (inactive ingredients) are in VEMURAFENIB?	VEMURAFENIB excipients list
DailyMed Link:	VEMURAFENIB at DailyMed

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

Dosage:

TABLET;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 VEMURAFENIB

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

Sponsor	Phase
University of Birmingham	Phase 2/Phase 3
Cancer Research UK	Phase 2/Phase 3
Royal Marsden NHS Foundation Trust	Phase 2/Phase 3

See all VEMURAFENIB clinical trials

Pharmacology for VEMURAFENIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 1A2 Inhibitors P-Glycoprotein Inhibitors Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for VEMURAFENIB

L01EC	B-Raf serine-threonine kinase (BRAF) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for VEMURAFENIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes			Y
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes			Y	Y
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for VEMURAFENIB

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Zelboraf	vemurafenib	EMEA/H/C/002409 Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.,	Authorised	no	no	no	2012-02-17

International Patents for VEMURAFENIB

Country	Patent Number	Title	Estimated Expiration
Mexico	2012005224	NUEVO PROCESO PARA LA MANUFACTURA DE PREPARACIONES FARMACEUTICAS. (PROPANE-I-SULFONIC ACID {3-[5-(4-CHLORO-PHENYL)-1H-PYRROLO[2,3-B] PYRIDINE-3-CARBONYL]-2,4-DIFLUORO-PHENYL}-AMIDE COMPOSITIONS AND USES THEREOF.)
South Korea	101440257
Israel	214328	דיספרסיה מוצקה של פרופאן-1-חומצה סולפונית {3-[5-(4-כלורו-פניל)-1h-פירולו[3,2-b] פירידין-3-קרבוניל]-4,2-דיפלואורו-פניל}-אמיד תכשיר המכיל אותה ושיטה להכנתה (Solid dispersion comprising propane-1-sulfonic acid {3-[5-(4-chloro-phenyl)-1h-pyrrolo [2,3-b] pyridine-3-carbonyl]-2,4-difluoro-phenyl}-amide, composition comprising the same and method for making the solid dispersion)
China	104910150	Process for the manufacture of pharmaceutically active compounds

Supplementary Protection Certificates for VEMURAFENIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893612	122 5012-2012	Slovakia		FIRST REGISTRATION NO/DATE: EU/1/12/751/001, 20120217
1893612	122012000043	Germany		PRODUCT NAME: VEMURAFENIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
1893612	CA 2012 00028	Denmark
1893612	462	Finland

VEMURAFENIB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Vemurafenib

Introduction to Vemurafenib

Vemurafenib, marketed under the brand name Zelboraf, is a targeted therapy used primarily in the treatment of metastatic melanoma with the BRAF V600E mutation. This drug works by inhibiting the BRAF V600E mutation in the MAPK signaling pathway, which is crucial for regulating cell growth and division, thereby slowing down or stopping the growth of cancer cells[1][4].

Market Growth and Drivers

Rising Incidence of Melanoma

The global market for vemurafenib has seen significant growth due to the increasing incidence of melanoma, particularly in regions with high UV exposure. This rise in melanoma cases drives the demand for effective treatment options like vemurafenib[1].

Advancements in Targeted Therapies

The growing emphasis on personalized medicine and targeted therapies in oncology has boosted the adoption of drugs like vemurafenib. These therapies offer improved efficacy and fewer side effects compared to conventional treatments, making them a preferred choice for patients and healthcare providers[1].

Investment in Research and Development

Substantial investments in research and development for cancer treatments have led to the development of new and improved formulations of vemurafenib. This includes combination therapies and extended indications for other types of cancers, further enhancing its market potential[1].

Key Players and Market Landscape

Pharmaceutical Giants and Biotechnology Firms

Leading pharmaceutical companies and biotechnology firms dominate the vemurafenib market. These companies leverage their expertise and resources to drive growth and innovation. Key players include F. Hoffmann-La Roche Ltd., Novartis AG, and other major pharmaceutical and biotech companies[1][4].

Recent Innovations

Recent innovations in the vemurafenib market include the development of combination therapies with other targeted therapies or immunotherapies. Research is also ongoing to explore the efficacy of vemurafenib in treating other types of cancers with BRAF mutations, potentially expanding its therapeutic applications[1].

Financial Trajectory

Cost-Effectiveness and Economic Evaluation

The economic evaluation of vemurafenib highlights its significant cost. The incremental cost-effectiveness ratio for vemurafenib is estimated to be between $227,571 and $279,433 per Quality-Adjusted Life Year (QALY) when compared to dacarbazine. This includes costs of treatment, medical resource utilization, and treatment of adverse events[3].

Long-Term Costs and Survival Benefits

Studies have shown that while vemurafenib offers significant survival benefits, its long-term costs are substantial. For instance, the cumulative costs per life-month gained with vemurafenib are estimated to be around $11,002 by year 7, compared to $4,281 for ipilimumab[2].

Market Size and Projection

The global vemurafenib market is expected to continue growing, driven by the increasing incidence of melanoma and advancements in cancer treatment. The BRAF kinase inhibitors market, which includes vemurafenib, is projected to grow from USD 1.27 billion in 2023 to USD 4.20 billion by 2028, with a Compound Annual Growth Rate (CAGR) of 7.93%[4].

Regional Market Dynamics

North America and Europe

North America and Europe are expected to dominate the market during the forecast period due to their advanced healthcare infrastructure, robust research environments, and early adoption of novel therapies. These regions have strong pharmaceutical industries, favorable healthcare coverage, and significant cancer burdens, which support the growth of the vemurafenib market[4].

Asia-Pacific and Other Regions

The Asia-Pacific region is anticipated to show lucrative growth due to the growing cancer burden, emerging economies, and diverse patient populations. Latin America, the Middle East, and Africa are also expected to grow at a healthy CAGR during the projected period, driven by government initiatives, medical tourism, and genomic advancements[4].

Challenges and Future Prospects

High Treatment Costs

One of the significant challenges facing the vemurafenib market is the high cost of treatment, which can limit access for patients in low-income regions. This cost barrier is a critical factor that healthcare providers and policymakers need to address[1].

Resistance and Side Effects

The development of resistance to vemurafenib and potential side effects are other challenges that require ongoing research and management strategies. These issues can impact the long-term efficacy and patient compliance with the treatment[1].

Future Growth Opportunities

Despite these challenges, the future prospects of the vemurafenib market are promising. The growing incidence of melanoma, advancements in personalized medicine, and opportunities in emerging markets are expected to drive further growth. Strategic partnerships and mergers, as well as collaborations with research institutions, will continue to play a significant role in shaping the market[1].

Key Takeaways

• Market Growth: The vemurafenib market is driven by the increasing incidence of melanoma and advancements in targeted therapies.
• Financial Trajectory: Vemurafenib is associated with high treatment costs but offers significant survival benefits.
• Regional Dynamics: North America and Europe dominate the market, while the Asia-Pacific region shows promising growth.
• Challenges: High treatment costs and potential resistance are key challenges.
• Future Prospects: The market is expected to grow due to advancements in personalized medicine and emerging market opportunities.

FAQs

What is the primary use of vemurafenib?

Vemurafenib is primarily used to treat metastatic melanoma with the BRAF V600E mutation by inhibiting the MAPK signaling pathway.

How does vemurafenib compare to other treatments in terms of cost-effectiveness?

Vemurafenib has a higher cumulative cost per life-month gained compared to ipilimumab, with costs estimated at $11,002 by year 7 for vemurafenib versus $4,281 for ipilimumab[2].

What are the key drivers of the vemurafenib market?

The key drivers include the rising incidence of melanoma, advancements in targeted therapies, and significant investments in research and development.

Which regions are expected to dominate the vemurafenib market?

North America and Europe are expected to dominate the market, followed by the Asia-Pacific region, which is anticipated to show lucrative growth.

What are the challenges facing the vemurafenib market?

High treatment costs and the development of resistance to vemurafenib are significant challenges that need to be addressed.

Sources

1. Market Research Intellect: Vemurafenib Market Analysis, Key Players, and Future Prospects Revealed.
2. PMC: Long-term drug costs per life-month gained associated with first-line treatments for metastatic melanoma.
3. pan-Canadian Oncology Drug Review: Final Economic Guidance Report - Vemurafenib.
4. Market Data Forecast: BRAF Kinase Inhibitors Market Size, Share & Growth, 2032.