CAPRELSA Drug Patent Profile

When do Caprelsa patents expire, and what generic alternatives are available?

Caprelsa is a drug marketed by Genzyme Corp and is included in one NDA. There is one patent protecting this drug.

This drug has forty patent family members in thirty-three countries.

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

DrugPatentWatch^® Generic Entry Outlook for Caprelsa

Caprelsa was eligible for patent challenges on April 6, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 8, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for CAPRELSA

International Patents:	40
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	17
Drug Prices:	Drug price information for CAPRELSA
What excipients (inactive ingredients) are in CAPRELSA?	CAPRELSA excipients list
DailyMed Link:	CAPRELSA at DailyMed

See drug prices for CAPRELSA

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

NDA:

022405

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 CAPRELSA

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

Sponsor	Phase
Samsung Medical Center	Phase 2
AstraZeneca	Phase 2
AstraZeneca	Phase 1

See all CAPRELSA clinical trials

Pharmacology for CAPRELSA

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

US Patents and Regulatory Information for CAPRELSA

CAPRELSA is protected by one US patents.

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

Expired US Patents for CAPRELSA

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	022405-001	Apr 6, 2011

EU/EMA Drug Approvals for CAPRELSA

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 CAPRELSA

See the table below for patents covering CAPRELSA around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	190326
South Africa	200202775	Quinazoline derivatives as VEGF inhibitors.
Malaysia	129540	QUINAZOLINE DERIVATIVES, PHARMACEUTICAL COMPOSITIONS CONTAINING THEM PROCESSES FOR THEIR PREPARATION AND THEIR USE IN THE PRODUCTION OF AN ANTIANGIOGENIC AND/OR VASCULAR PERMEABILITY REDUCING EFFECT
Brazil	PI0511253	composição farmacêutica
Slovenia	1753431
Luxembourg	92057

Supplementary Protection Certificates for CAPRELSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1244647	C01244647/01	Switzerland		FORMER OWNER: ASTRAZENECA AB, SE
1244647	CA 2012 00032	Denmark
1244647	92057	Luxembourg		92057, EXPIRES: 20251101
1244647	2012C/036	Belgium		PRODUCT NAME: VANDETANIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/11/749/001 20120221
1244647	C 2012 023	Romania		PRODUCT NAME: VANDETANIB SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/749/001, RO EU/1/11/749/002; DATE OF NATIONAL AUTHORISATION: 20120217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/749/001, EMEA EU/1/11/749/002; DATE OF FIRST AUTHORISATION IN EEA: 20120217
1244647	419	Finland

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CAPRELSA

Last updated: July 27, 2025

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Introduction

Caprelsa (vandetanib) is an oral kinase inhibitor developed by AstraZeneca, primarily approved for the treatment of medullary thyroid carcinoma (MTC). Since its FDA approval in 2011, Caprelsa has navigated a complex landscape shaped by clinical efficacy, regulatory considerations, market competition, and evolving healthcare needs. This analysis explores the current market dynamics influencing Caprelsa's financial trajectory, outlining growth drivers, challenges, and strategic opportunities shaping its future outlook.

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Understanding Caprelsa and Its Therapeutic Context

Caprelsa targets multiple tyrosine kinases, including RET (rearranged during transfection), VEGFR (vascular endothelial growth factor receptor), and EGFR (epidermal growth factor receptor) pathways. Its primary indication, MTC—a rare form of thyroid cancer accounting for roughly 1-2% of all thyroid malignancies—positions Caprelsa within niche oncology markets. While the drug demonstrates a significant clinical benefit in treating advanced or metastatic MTC, the market remains constrained by disease prevalence and competition from emerging therapies.

Market Size and Epidemiology

Medullary thyroid carcinoma's rarity limits the overall sales potential. Incidence rates vary globally, with estimates of 2-4 cases per million annually in the US and European markets [1]. Consequently, the total addressable market remains limited, emphasizing the importance of strategic positioning and market expansion efforts for sustained revenue growth.

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Market Dynamics Influencing Caprelsa

1. Competitive Landscape

In the realm of targeted therapies for MTC, Caprelsa faces competition from other kinase inhibitors like selpercatinib (LOXO-292) and pralsetinib (Retevmo), progressing through regulatory pathways with promising efficacy profiles and potential advantages. The emergence of selective RET inhibitors presents a formidable challenge, especially given their potentially superior safety and efficacy margins. The degree to which these agents replace or complement Caprelsa directly impacts its market share.

2. Regulatory and Pricing Environment

Regulatory decisions globally influence Caprelsa’s market penetration. In the US and EU, regulatory approvals facilitated by robust clinical data support sales, but reimbursement policies and pricing pressures introduce constraints. Pricing strategies must balance profitability with payer acceptability, especially as healthcare systems tighten budgets around expensive oncology treatments.

3. Clinical Adoption and Physician Preferences

Physicians tend to favor therapies with higher response rates, tolerability, and clear survival benefits. Clinical guidelines increasingly incorporate newer agents, which can either complement or displace Caprelsa. Its current positioning relies heavily on clinician familiarity, safety profile, and the absence of universally superior alternatives.

4. Patient and Disease Dynamics

As MTC is diagnosed mostly at advanced stages, treatment options are limited. However, increased genetic testing for RET mutations—often damaging driver mutations in MTC—facilitates targeted therapy selection and may broaden the use of RET inhibitors, impacting Caprelsa’s utilization.

5. Ancillary Market Opportunities

Off-label or expanded indications, such as other RET-driven tumors, could present future growth avenues. Additionally, combination therapies with immuno-oncology agents are under investigation, potentially enhancing Caprelsa’s horizon.

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Financial Trajectory and Revenue Projections

Past Performance

Since its launch, Caprelsa experienced moderate sales growth, peaking around $200 million annually pre-pandemic, driven by its niche but significant clinical niche. However, sales plateaued due to competition and limited indications, with generic pressure emerging in some markets (notably India and other countries with significant generic penetration) impacting profitability.

Future Outlook

The forecasted financial trajectory hinges on several factors:

• Market Penetration of New RET Inhibitors: As selective RET inhibitors like selpercatinib receive approval and enter commercial use, they threaten to displace Caprelsa, especially if they demonstrate superior efficacy and tolerability.

• Regulatory Extensions: Securing expanded indications beyond MTC, potentially in other RET-driven malignancies, could significantly uplift revenues.

• Pricing and Reimbursement Strategies: Maintaining favorable reimbursement through demonstrating cost-effectiveness will be critical. Payer negotiations and value-based pricing models influence profit margins.

• Pipeline and Companion Diagnostic Integration: Collaboration with diagnostic firms to identify RET mutations and optimize patient selection can enhance the drug’s clinical value and sales efficiency.

• Market Access and Geographic Expansion: Expanding into emerging markets with rising cancer prevalence and improving healthcare access could diversify revenue streams.

Analysts project that Caprelsa’s global sales could diminish to a low double-digit million dollar range in the coming years unless strategic initiatives and pipeline developments offset competition and patent expirations. Conversely, targeted expansion into new indications or markets could stabilize or moderately increase its revenue base.

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Strategic Challenges and Opportunities

Challenges

• The advent of highly selective RET inhibitors that offer improved tolerability and efficacy.
• Limited indications confine overall market size.
• Pricing pressures amid healthcare cost containment policies.
• Expiry of patent protections and the associated rise of generics in some geographies.

Opportunities

• Broadening indications to other RET-driven cancers, such as non-small cell lung carcinoma (NSCLC), medullary thyroid carcinoma variants, or certain neuroendocrine tumors.
• Developing combination therapies that leverage Caprelsa’s mechanism to improve outcomes.
• Adoption of molecular diagnostics for better patient stratification.
• Strategic partnerships or licensing deals to extend its market lifespan.

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Conclusion

Caprelsa’s market dynamics reflect a paradigm common to niche oncology agents: a limited but critical role in targeted therapy, susceptible to rapid shifts driven by innovation, regulatory changes, and healthcare economics. Its financial prospects hinge on successfully navigating intensifying competition from newer, more selective treatments and leveraging opportunities for indication expansion. AstraZeneca’s continued investment in clinical development, strategic partnerships, and market access initiatives will predominantly shape Caprelsa’s long-term financial trajectory.

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Key Takeaways

• Caprelsa maintains a niche but vital position in MTC treatment, with its market constrained by rarity and emerging competitors.
• The rise of selective RET inhibitors presents both a threat and an opportunity, emphasizing the need for differentiation.
• Expanding indications and integrating advanced diagnostics can enhance its market relevance.
• Price and reimbursement are critical factors influencing future sales amid cost containment policies.
• Strategic agility and pipeline diversification will determine whether Caprelsa sustains or declines in revenue over the next decade.

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FAQs

1. What are the primary competitive threats to Caprelsa’s market share?
Selective RET inhibitors like selpercatinib and pralsetinib provide targeted, often more tolerable therapies with demonstrated efficacy, posing substantial competition, especially for RET-driven cancers.

2. Are there plans to expand Caprelsa’s indications beyond medullary thyroid carcinoma?
Regulatory and clinical research efforts are exploring its potential in other RET-driven malignancies, which could broaden its therapeutic scope.

3. How does pricing influence Caprelsa’s market sustainability?
Pricing strategies must balance recoupment and competitiveness, particularly as health systems push for cost-effective oncology solutions, impacting profit margins.

4. What role does molecular testing play in Caprelsa’s future?
Genetic testing for RET mutations facilitates targeted therapy, ensuring appropriate patient selection and maximizing treatment effectiveness.

5. What strategic actions can AstraZeneca undertake to prolong Caprelsa’s market life?
Investing in pipeline expansion, securing new indications, forming strategic alliances, and enhancing diagnostic integration constitute key steps to sustain its commercialization.

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References

[1] American Cancer Society. Thyroid Cancer Statistics. 2022.