Vandetanib - Generic Drug Details

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

Vandetanib is the generic ingredient in one branded drug marketed by Genzyme Corp and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Vandetanib has forty patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for vandetanib

International Patents:	40
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	91
What excipients (inactive ingredients) are in vandetanib?	vandetanib excipients list
DailyMed Link:	vandetanib at DailyMed

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

Constraining patent/regulatory exclusivity:

8,067,427

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 vandetanib

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

Sponsor	Phase
Hoffmann-La Roche	Phase 3
West China Hospital	PHASE2
Loxo Oncology, Inc. a wholly owned subsidiary of Eli Lilly and Company	Phase 3

See all vandetanib clinical trials

Pharmacology for vandetanib

Drug Class	Kinase Inhibitor
Mechanism of Action	Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for vandetanib

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for vandetanib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011		RX	Yes	No	8,067,427		Y
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011		RX	Yes	Yes	8,067,427		Y

Expired US Patents for vandetanib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011	6,414,148
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011	7,173,038
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011	RE42353

EU/EMA Drug Approvals for vandetanib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sanofi B.V.	Caprelsa	vandetanib	EMEA/H/C/002315Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.Caprelsa is indicated in adults, children and adolescents aged 5 years and older.For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.	Authorised	no	no	no	2012-02-16

International Patents for vandetanib

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005112934
Croatia	P20090547
Slovenia	1753431

Supplementary Protection Certificates for vandetanib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1244647	SPC/GB12/036	United Kingdom		PRODUCT NAME: VANDETANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/749/001 20120217; UK EU/1/11/749/002 20120217
1244647	C300543	Netherlands		PRODUCT NAME: VANDETANIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
1244647	300543	Netherlands		PRODUCT NAME: VANDETANIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217

Market Dynamics and Financial Trajectory for Vandetanib

Last updated: March 5, 2026

What is Vandetanib?

Vandetanib is an oral tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR-2), epidermal growth factor receptor (EGFR), and rearranged during transfection (RET) kinase. It is approved for treating metastatic medullary thyroid carcinoma (MTC) by the FDA and other regulatory agencies.

Market Overview

Vandetanib operates within the targeted cancer therapy segment, predominantly for thyroid cancers. Here are key market elements:

• Indications: Metastatic medullary thyroid carcinoma.
• Market exclusivity: Patents expired or nearing expiration in several regions.
• Competitive landscape: Competes against cabozantinib (another RET inhibitor), sorafenib, and lenvatinib (multi-kinase inhibitors).

Regulatory and Patent Status

• FDA approval: April 2011 for MTC.
• European approval: September 2011.
• Patent lifecycle: Original patents filed in 2002, with expiration expected around 2025-2028.[1]
• Generic entry risk: High post-expiry, potentially reducing revenue substantially.

Sales and Revenue Data

Vandetanib historically generated modest revenues, reflecting niche use:

Year	Worldwide Sales (USD millions)	Notes
2012	250	Initial sales following approval.
2015	180	Decline due to increasing competition.
2020	140	Further erosion with generics nearing.
2022	110	Continued decline.

Global sales hinge on the prevalence of MTC (approx. 1,000 new cases annually in the US) and the drug’s market penetration.

Market Challenges

• Limited patient pool: MTC accounts for less than 1% of all thyroid cancers, constraining revenue.
• Treatment alternatives: Cabozantinib and other multi-kinase inhibitors show similar efficacy, competing for market share.
• Patent expiration: Approaching 2025, threatening generic erosion.
• Regulatory barriers: Indications limited mostly to MTC; no expansion to broader thyroid or other cancer types.

Growth Opportunities and Risks

Opportunities

• New indications: Potential clinical approval for other RET-driven cancers.
• Combination therapies: Trials investigating Vandetanib plus immunotherapies.
• Biomarker development: Enhances patient selection, improving efficacy and market adoption.

Risks

• Generic competition: Entry expected within 1-3 years of patent expiry.
• Pipeline stagnation: Lack of development for additional indications limits long-term revenues.
• Pricing pressure: Payers demand cost-effective treatments, particularly in markets with constrained healthcare budgets.

Competitive Landscape

Drug	Target/Indication	Approvals	Market Share (2022)	Key Advantages
Vandetanib	RET, VEGFR2, EGFR for MTC	2011 (FDA)	50%	Specific RET inhibition
Cabozantinib	RET, VEGFR, metastatic thyroid	2012 (FDA)	30%	Broader targeting, more flexible
Lenvatinib	Multiple kinase inhibition	2015 (FDA)	10%	Approved for differentiated thyroid cancer
Sorafenib	Multikinase inhibitor	2005 (FDA)	10%	Longer market presence

Financial Outlook

From 2023 onward, revenues will decline due to patent expiry and competition, compounded by limited indications:

• Pre-expiry forecasts: Revenue stabilization around USD 100-120 million.
• Post-expiry projections: Drop by 50-70% within two years of patent loss due to generics.
• Investment in pipeline: Required to sustain revenue growth; current R&D focuses on combination therapies and expanding indications.

Strategic Considerations

• Patent enforcement: Companies may pursue litigation or secondary patents to extend exclusivity.
• Market penetration: Strengthen label use in other RET-positive cancers.
• Pricing strategies: Flexible pricing and managed access to mitigate revenue loss.

Key Takeaways

• Vandetanib’s revenue is constrained by a limited, niche market and upcoming patent expires.
• Competitive pressure from other RET and multi-kinase inhibitors limits market share.
• Generic entry is imminent, sharply impacting sales and profitability.
• Expansion into new indications and biomarker-driven treatments present growth avenues.
• Long-term viability relies on pipeline development and strategic market positioning.

FAQs

1. When does Vandetanib’s patent expire?
   Patent protection is expected to end around 2025-2028, depending on jurisdiction and patent extensions.

2. What are the main competitors of Vandetanib?
   Cabozantinib, lenvatinib, sorafenib, and emerging RET inhibitors like selpercatinib.

3. Can Vandetanib be used for other cancers?
   Currently, its approved indication is metastatic medullary thyroid carcinoma. Research is ongoing for other RET-driven tumors.

4. What is the potential impact of generics on Vandetanib’s revenue?
   Generics could reduce revenues by 50-70% within two years of patent expiry.

5. Are there any ongoing clinical trials for Vandetanib?
   Yes, trials are investigating combinations with immunotherapies and new indications, but results are pending.

Sources

[1] U.S. Food and Drug Administration. (2011). Vandetanib NDA approval documents.