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:	90
Patent Applications:	7,474
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
Eli Lilly and Company	Phase 3
Loxo Oncology, Inc.	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	022405-002	Apr 6, 2011	6,414,148
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	8,642,608
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011	7,173,038
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011	RE42353
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011	8,642,608

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/002315 Caprelsa 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
Denmark	1753431
Germany	602005016105
Australia	2005244650	Pharmaceutical compositions comprising ZD6474
Croatia	P20090547
Cyprus	1109500
Taiwan	I355269

Supplementary Protection Certificates for VANDETANIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1244647	1290028-8	Sweden		PRODUCT NAME: VANDETANIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/11/749/001 20120217
1244647	122012000057	Germany		PRODUCT NAME: VANDETANIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; 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	PA2012015,C1244647	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

VANDETANIB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vandetanib

Introduction to Vandetanib

Vandetanib, marketed under the brand name Caprelsa, is an antineoplastic kinase inhibitor used to treat symptomatic or progressive medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Here, we delve into the market dynamics and financial trajectory of this critical drug.

Market Size and Growth

The global thyroid cancer drugs market, which includes Vandetanib, is experiencing significant growth. In 2022, the market size was approximately $0.72 billion and is projected to reach $1.33 billion by 2026, growing at a compound annual growth rate (CAGR) of 16.7%[1].

Specifically, the global thyroid cancer drug market, which Vandetanib is a part of, was valued at USD 712.56 million in 2022 and is expected to grow to USD 2,505.56 million by 2030, with a CAGR of 17.2% during the forecast period of 2023-2030[3].

Key Drivers of the Market

Several factors are driving the growth of the thyroid cancer drugs market, including:

Increasing Incidence of Thyroid Cancer

The incidence of thyroid cancer, particularly in women, is rising. According to the American Cancer Society, women are three times more likely to develop thyroid cancer than men. This increase in incidence is a significant driver for the market[1].

Targeted Therapies

Vandetanib, as a targeted therapy, is one of the key drivers. Targeted therapies like Vandetanib and Cabozantinib are increasingly preferred for treating advanced medullary thyroid cancer because they target specific genes, proteins, and tissues that promote cancer growth and survival[1].

Combination Therapies

The use of combination drugs, which include multiple active pharmaceutical ingredients (APIs) in a single dosage form, is also on the rise. These combinations are more effective and help prevent cancer progression and drug resistance. Although Vandetanib is often used as a monotherapy, the trend towards combination therapies could influence its market dynamics[1].

Financial Performance and Revenue

Revenue Contribution

Vandetanib is a significant contributor to the revenue of companies involved in the thyroid cancer drug market. For instance, it is one of the key drugs mentioned in market reports alongside other targeted therapies like Cabozantinib and Lenvatinib[1][3].

Cost-Effectiveness Analysis

While Vandetanib is effective, its cost-effectiveness is a critical factor in its financial trajectory. Economic analyses indicate that the incremental cost-effectiveness ratios (ICERs) for Vandetanib are high, exceeding £66,000 per quality-adjusted life-year (QALY) gained in certain patient populations. This high cost can impact its adoption and reimbursement, affecting its revenue[5].

Regional Market Impact

The global market for thyroid cancer drugs, including Vandetanib, is segmented by region. North America is currently the largest market, but the Middle East is expected to be the fastest-growing region during the forecast period. This regional growth can influence the financial performance of Vandetanib[1].

End Users and Distribution

Healthcare Settings

Vandetanib is used in various healthcare settings, including hospitals, oncology clinics, and research organizations. The distribution and sales channels through these settings contribute to its revenue and market presence[1].

Patient Demographics

The drug is primarily used for treating medullary thyroid cancer, which has a specific patient demographic. Understanding and targeting this demographic is crucial for the financial success of Vandetanib[4].

Competitive Landscape

Market Players

The thyroid cancer drug market is competitive, with several major players. Bristol Myers Squibb, although not directly mentioned as a manufacturer of Vandetanib, is a significant player in the broader oncology market and influences the competitive landscape through its portfolio and pipeline activities[2].

Other Targeted Therapies

Drugs like Cabozantinib and Lenvatinib are competitors in the targeted therapy segment for thyroid cancer. The performance and pricing of these drugs can impact the market share and financial trajectory of Vandetanib[1][3].

Regulatory and Approval Aspects

FDA Approval

Vandetanib was approved by the FDA on April 6, 2011, for the treatment of nonresectable, locally advanced, or metastatic medullary thyroid cancer in adult patients. This approval is a critical factor in its market presence and financial performance[4].

Orphan Drug Designation

Vandetanib has received orphan drug designation in the USA and EU, which can provide certain market exclusivities and incentives, potentially enhancing its financial trajectory[4].

Challenges and Restraints

High Cost and Cost-Effectiveness

The high cost of Vandetanib and its associated ICERs can be a significant restraint. High costs may limit its adoption and reimbursement, affecting its revenue and market growth[5].

Side Effects and Contraindications

Vandetanib has contraindications, such as prolonging the Q-T interval, which can be a restraint in its use for patients with certain cardiac conditions. Managing these side effects is crucial for maintaining patient safety and market confidence[4].

Future Outlook

Pipeline and Research

Continued research and development in targeted therapies and combination treatments will shape the future of Vandetanib. New pipeline developments and potential approvals can either complement or compete with Vandetanib, influencing its market dynamics[1][3].

Market Expansion

The growing incidence of thyroid cancer and the expanding use of targeted therapies in emerging markets are expected to drive the growth of Vandetanib. However, the high cost and cost-effectiveness will remain critical factors to be addressed[1][3].

Key Takeaways

• Market Growth: The thyroid cancer drug market, including Vandetanib, is expected to grow significantly, driven by increasing incidence and the use of targeted therapies.
• Financial Performance: Vandetanib contributes substantially to the revenue of companies in this market, but its high cost and ICERs are significant factors.
• Competitive Landscape: The market is competitive with other targeted therapies, and regulatory approvals and orphan drug designations play a crucial role.
• Challenges: High costs, side effects, and contraindications are restraints that need to be managed.

FAQs

What is Vandetanib used for?

Vandetanib is used to treat symptomatic or progressive medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease[4].

How does Vandetanib work?

Vandetanib is a potent and selective inhibitor of VEGFR, EGFR, and RET tyrosine kinases, which are clinically validated pathways in cancer[4].

What are the key drivers of the thyroid cancer drug market?

The key drivers include the increasing incidence of thyroid cancer, the use of targeted therapies, and the adoption of combination therapies[1].

What are the challenges facing Vandetanib in the market?

High costs, high ICERs, side effects, and contraindications are significant challenges that impact its adoption and revenue[5].

What is the future outlook for Vandetanib?

The future outlook is influenced by continued research, pipeline developments, and market expansion, but addressing the high cost and cost-effectiveness will be crucial[1][3].

Sources

1. Thyroid Cancer Drugs Global Market Research Report 2022 - ResearchAndMarkets.com
2. Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2023 - Business Wire
3. Global Thyroid Cancer Drug Market Size, Share & Revenue Analysis By 2030 - Data Bridge Market Research
4. Vandetanib: Uses, Interactions, Mechanism of Action - DrugBank
5. Cabozantinib and vandetanib for unresectable locally advanced or metastatic medullary thyroid cancer - PubMed