VANDETANIB - Generic Drug Details

What are the generic drug 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

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
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	022405-002	Apr 6, 2011		RX	Yes	Yes			Y
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011		RX	Yes	No			Y

Expired US Patents for VANDETANIB

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

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
Brazil	PI0511253	composição farmacêutica
Japan	2007538060
South Africa	200609110	Pharmaceutical compositions comprising ZD6474
Poland	1753431
Argentina	110045	COMPOSICIONES FARMACÉUTICAS
Uruguay	28901	COMPOSICIONES FARMACEUTICAS CONTENIENDO ZD6474 O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LAS MISMAS, DILUYENTES Y PROCESOS PARA SU PREPARACIÓN

Supplementary Protection Certificates for VANDETANIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1244647	12C0048	France		PRODUCT NAME: VANDETANIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/749/002 20120217
1244647	PA2012015	Lithuania		PRODUCT NAME: VANDETANIBUM; REGISTRATION NO/DATE: EU/1/11/749/001, 2012 02 17 EU/1/11/749/002 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
1244647	2012/029	Ireland		PRODUCT NAME: VANDETANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/11/749/001-002 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	1290028-8	Sweden		PRODUCT NAME: VANDETANIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/11/749/001 20120217

Market Dynamics and Financial Trajectory for Vandetanib

Last updated: July 28, 2025

Introduction
Vandetanib, marketed as Caprelsa among other names, is an oral multikinase inhibitor developed by AstraZeneca primarily for the treatment of medullary thyroid carcinoma (MTC). Since its FDA approval in 2011, the drug has navigated a complex landscape of market dynamics influenced by therapeutic demand, competitive drug development, and regulatory evolutions. This analysis explores the current market environment, revenue trajectory, competitive positioning, and future prospects for vandetanib within the global pharmaceutical landscape.

Market Overview and Therapeutic Demand
Vandetanib addresses metastatic or inoperable medullary thyroid carcinoma—a rare endocrine malignancy with limited treatment options. The orphan status grants certain market exclusivities, bolstering its commercial prospects. Although MTC accounts for approximately 3–4% of all thyroid cancers, its incidence varies geographically, with higher prevalence in East Asia.

The limited patient population initially restricted sales; however, the drug's approval catalyzed growth as awareness increased and more clinicians adopted targeted therapy protocols. The pivotal Zactima (vandetanib) approval underscored the shift toward precision medicine in thyroid cancer management, aligning with broader oncology trends favoring targeted kinase inhibitors.

Market Dynamics
Regulatory Environment and Approvals
Since the initial FDA approval, vandetanib has received regulatory validations across multiple jurisdictions, including the European Medicines Agency (EMA). The drug's orphan designation has provided market exclusivity, incentivizing continued investment and commercialization efforts.

Competitive Landscape
Vandetanib faces competition from newer tyrosine kinase inhibitors (TKIs) like cabozantinib and selpercatinib, which target RET mutations more specifically. Cabozantinib gained FDA approval for MTC in 2018, providing competitive pressure partly due to its broader kinase targeting and demonstrated efficacy in tumor control. The emergence of RET-specific inhibitors offers a highly targeted alternative, potentially diminishing vandetanib’s market share over time.

Pricing and Reimbursement
Pricing strategies for vandetanib have varied significantly across markets, shaped by health technology assessments and reimbursement policies. In mature markets like the US and Europe, the high cost of targeted therapies influences prescribing patterns, with payers favoring drugs demonstrating superior efficacy or improved safety over alternatives.

Physician and Patient Adoption
Clinicians favor drugs with manageable safety profiles and proven survival benefits. Vandetanib’s safety profile, including risks of QT prolongation and diarrhea, has influenced prescribing, especially as new agents with more favorable profiles have entered the market.

Financial Trajectory
Historical Revenue Performance
Following its launch, vandetanib experienced steady growth, with peak sales reaching approximately $200 million globally in the late 2010s (exact figures vary by source) (1). The drug’s revenue was driven by increased diagnosis, secure regulatory approval, and its positioning as a standard of care for advanced MTC.

Impact of Competitive Products
The advent of alternative therapies has tempered growth, with some reports indicating a plateau or slight decline in revenue since 2018 (2). This trend correlates with the adoption of RET inhibitors like selpercatinib, which have shown superior efficacy and safety in clinical trials.

Future Revenue Projections
Forecasting future financials involves assessing unmet medical needs, regulatory pipelines, and evolving competitive dynamics. If vandetanib maintains its orphan drug status and captures treatment of early-stage MTC, it could sustain revenues in the range of $100–150 million annually over the next 3–5 years. However, the accelerated adoption of emergent, more targeted agents could pressure sales downward unless the drug’s label expands or its clinical utility broadens.

Factors Influencing the Financial Outlook

• Regulatory extensions:** Additional patents or indications could extend market exclusivity.
• Pipeline developments: Combination therapies or new formulations may enhance efficacy or safety, revitalizing demand.
• Pricing negotiations: Payer acceptance of pricing strategies will impact revenue retention.
• Clinical guideline updates: Inclusion in standard-of-care protocols ensures sustained usage.

Long-Term Considerations
Given the trend toward personalized medicine in oncology, vandetanib’s long-term profitability hinges on its ability to adapt to evolving standards. The rise of RET-specific inhibitors, tailored treatments based on genetic profiling, and the shrinking pool of eligible patients present challenges to sustained growth. Conversely, ongoing research into combination regimens and potential new indications could provide renewed revenue streams.

Conclusion
Vandetanib’s market dynamics are shaped by its initial success in bringing targeted therapy to rare thyroid cancers, but increasingly challenged by newer, more specific agents. Its financial trajectory is expected to moderate as the competitive landscape intensifies, although orphan drug protections afford some degree of market stability. Strategic positioning—through pipeline expansion, label indications, and competitive differentiation—will determine its profitability trajectory over the coming years.

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Key Takeaways

• Vandetanib remains a key therapy for metastatic medullary thyroid carcinoma, with peak revenues historically near $200 million.
• The advent of RET-specific inhibitors and other targeted agents has begun to erode its market share, emphasizing the need for differentiation.
• Market exclusivities and orphan drug status provide some insulation, but long-term growth depends on pipeline development and regulatory approvals.
• Pricing strategies and reimbursement policies significantly influence financial performance amidst increasing competition.
• Future success relies on broadening indications, optimizing safety profiles, and leveraging advances in precision oncology.

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FAQs

1. How does vandetanib compare with newer treatments like selpercatinib for MTC?
   Selpercatinib, a RET-specific inhibitor, has demonstrated superior efficacy and safety profiles in clinical trials, leading to increased adoption. Vandetanib may be used in cases where prior therapies are ineffective or contraindicated, but the trend favors newer agents for targeted therapy.

2. What are the patent prospects for vandetanib considering recent generic entries?
   Vandetanib's initial patents have largely expired; however, secondary patents and orphan exclusivities may extend market protection until at least 2025–2030, depending on jurisdiction and patent strategies.

3. Are there off-label uses or expanded indications for vandetanib?
   Currently, vandetanib's approved indication focuses on medullary thyroid carcinoma. Off-label utilization is minimal and limited due to efficacy and safety considerations; ongoing research may expand its use to other RET-driven tumors.

4. What pricing strategies are employed across major markets for vandetanib?
   Pricing varies based on healthcare system budgets, reimbursement policies, and competitive landscape. In the US, it typically sells for several thousand dollars per month, negotiated with payers for coverage.

5. What are the primary challenges facing vandetanib’s future market?
   The main challenges include competition from RET-specific inhibitors, small patient populations, safety concerns, and the need for ongoing patent protection to sustain profitability.

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References

1. [1] AstraZeneca. “Caprelsa (Vandetanib) Prescribing Information,” 2011.
2. [2] IQVIA. “Pharmaceutical Market Reviews,” 2022.