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ZELBORAF Drug Patent Profile

Which patents cover Zelboraf, and when can generic versions of Zelboraf launch?

Zelboraf is a drug marketed by Hoffmann La Roche and is included in one NDA. There are six patents protecting this drug.

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

The generic ingredient in ZELBORAF is vemurafenib. One supplier is listed for this compound. Additional details are available on the vemurafenib profile page.

DrugPatentWatch^® Generic Entry Outlook for Zelboraf

Zelboraf was eligible for patent challenges on August 17, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 6, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZELBORAF

International Patents:	198
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	53
Patent Applications:	3,447
Drug Prices:	Drug price information for ZELBORAF
What excipients (inactive ingredients) are in ZELBORAF?	ZELBORAF excipients list
DailyMed Link:	ZELBORAF at DailyMed

See drug prices for ZELBORAF

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

NDA:

202429

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 ZELBORAF

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

Sponsor	Phase
University of Manchester	Phase 2/Phase 3
Hoffmann-La Roche	Phase 2/Phase 3
University of Birmingham	Phase 2/Phase 3

See all ZELBORAF clinical trials

Pharmacology for ZELBORAF

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

US Patents and Regulatory Information for ZELBORAF

ZELBORAF is protected by seven US patents and one FDA Regulatory Exclusivity.

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
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes	8,470,818
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes	7,504,509		Y	Y
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes	9,447,089		Y
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes

EU/EMA Drug Approvals for ZELBORAF

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 ZELBORAF

When does loss-of-exclusivity occur for ZELBORAF?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Germany

Honduras

Hong Kong

Hungary

Israel

Japan

Jordan

Malaysia

Mexico

Morocco

New Zealand

Nicaragua

Peru

Poland

Portugal

Russian Federation

San Marino

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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 ZELBORAF around the world.

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 ZELBORAF

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

ZELBORAF Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zelboraf (Vemurafenib)

Introduction to Zelboraf (Vemurafenib)

Zelboraf, also known as vemurafenib, is a targeted therapy used in the treatment of advanced melanoma, specifically in patients with a BRAF V600 mutation. This drug has significantly impacted the melanoma treatment landscape since its approval.

Market Size and Growth

The melanoma market, driven by advancements in targeted therapies like Zelboraf, is expected to experience substantial growth. As of 2023, the melanoma market size was valued at USD 3.9 billion, and it is projected to reach USD 8.9 billion by 2034, with a Compound Annual Growth Rate (CAGR) of 7.93% during 2024-2034[4].

Development and Approval Costs

The development and approval of Zelboraf involved significant financial investment. The estimated development and approval cost for Zelboraf was approximately $260 million in 2018. Additionally, the expected capitalized cost was $1,596.2 million, reflecting the extensive resources required to bring this drug to market[1].

Clinical Value and Cost-Effectiveness

Zelboraf has demonstrated strong clinical value, particularly in improving progression-free survival and overall survival in patients with BRAF V600 mutation-positive advanced melanoma. The Economic Guidance Panel estimated the incremental cost-effectiveness ratio of Zelboraf to be between $227,571 and $279,433 per Quality-Adjusted Life Year (QALY) when compared to dacarbazine, highlighting its cost-effectiveness despite high treatment costs[3].

Treatment Costs

The cost of Zelboraf is substantial. At the recommended dose of 960 mg twice daily, the daily cost is $372.32, and the average cost for a 28-day course is $10,425.34. This high cost is a significant factor in the overall budget impact analysis for healthcare systems[3].

Market Share and Competition

Zelboraf competes in a market with several other drugs for melanoma treatment. The drug's market share is influenced by factors such as the capture rate of BRAF mutation testing and the prevalence of melanoma. Despite competition, Zelboraf remains a key player in the targeted therapy segment, particularly for patients with the BRAF V600 mutation[3].

Sales Performance

The sales performance of Zelboraf has been notable. In the first nine quarters after its launch, Zelboraf generated sales of $475.31 million in 2018. This strong sales performance underscores the drug's market acceptance and clinical utility[1].

Financial Impact on Pharmaceutical Companies

For pharmaceutical companies like Roche, which developed Zelboraf, the financial impact is significant. The revenue generated from Zelboraf contributes to the company's overall financial health and supports further research and development in oncology.

Example: Revolution Medicines

While not directly related to Zelboraf, the financial strategies of other biotech companies like Revolution Medicines provide insight into how such drugs can impact a company's financial trajectory. Revolution Medicines, for instance, raised $345 million in a public offering in March 2023 to support its product pipeline, including late-stage clinical development and regulatory planning. This kind of financing is crucial for sustaining the development and commercialization of innovative drugs like Zelboraf[2].

Regulatory and Economic Considerations

Regulatory approvals and economic evaluations play a critical role in the market dynamics of Zelboraf. Health technology assessments (HTAs) and economic guidance reports, such as those from the pan-Canadian Oncology Drug Review, help determine the drug's cost-effectiveness and budget impact. These assessments are essential for healthcare systems to make informed decisions about drug reimbursement and access[3].

Patient Access and Reimbursement

Patient access to Zelboraf is influenced by reimbursement policies and healthcare system budgets. The high cost of the drug necessitates careful consideration of reimbursement strategies to ensure that patients who need the treatment can access it. This often involves negotiations between pharmaceutical companies, healthcare providers, and insurance payers.

Future Outlook

The future outlook for Zelboraf remains positive, driven by ongoing advancements in targeted therapies and immunotherapies. As the melanoma market continues to grow, Zelboraf is expected to remain a significant player, particularly for patients with the BRAF V600 mutation.

Advancements in Immunotherapy

The integration of Zelboraf with other therapies, such as MEK inhibitors, and advancements in immunotherapy are expected to further enhance treatment outcomes for melanoma patients. This synergistic approach is likely to drive continued market growth and reinforce Zelboraf's position in the treatment landscape[4].

Key Takeaways

• Market Growth: The melanoma market is projected to reach USD 8.9 billion by 2034, driven by advancements in targeted and immunotherapies.
• Clinical Value: Zelboraf has demonstrated strong clinical value, improving progression-free survival and overall survival in patients with BRAF V600 mutation-positive advanced melanoma.
• Cost-Effectiveness: Despite high treatment costs, Zelboraf is considered cost-effective, with an incremental cost-effectiveness ratio between $227,571 and $279,433 per QALY.
• Financial Impact: The drug's sales performance and revenue generation are significant for pharmaceutical companies, supporting further research and development.
• Regulatory Considerations: Regulatory approvals and economic evaluations are crucial for determining the drug's market dynamics and patient access.

FAQs

Q1: What is Zelboraf used for?

Zelboraf (vemurafenib) is used in the treatment of advanced melanoma, specifically in patients with a BRAF V600 mutation.

Q2: How much does Zelboraf cost?

The daily cost of Zelboraf is $372.32, and the average cost for a 28-day course is $10,425.34.

Q3: What is the expected market size of the melanoma market by 2034?

The melanoma market is expected to reach USD 8.9 billion by 2034, with a CAGR of 7.93% during 2024-2034.

Q4: How does Zelboraf compare to other treatments in terms of cost-effectiveness?

Zelboraf has an incremental cost-effectiveness ratio between $227,571 and $279,433 per QALY when compared to dacarbazine, indicating its cost-effectiveness.

Q5: What are the key factors influencing the market dynamics of Zelboraf?

Key factors include the capture rate of BRAF mutation testing, the prevalence of melanoma, regulatory approvals, and economic evaluations.

Sources:

1. NCBI: Table A - 19, Zelboraf (vemurafenib) Information.
2. Revolution Medicines: Revolution Medicines Reports First Quarter 2023 Financial Results.
3. pan-Canadian Oncology Drug Review: pCODR Final Economic Guidance Report – Vemurafenib (Zelboraf) for Advanced Melanoma.
4. BioSpace: Melanoma Market to Reach USD 8.9 Billion by 2034.