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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
Patent Applications:	4,557
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/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 CAPRELSA

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

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0511253	composição farmacêutica
Czech Republic	9901039
Hong Kong	1099220	PHARMACEUTICAL COMPOSITIONS COMPRISING ZD6474
Iceland	6335
Germany	60039206
China	1387527

Supplementary Protection Certificates for CAPRELSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122012000001	Germany		PRODUCT NAME: IPILIMUMAB; REGISTRATION NO/DATE: EU/1/11/698/001-002 20110713
1244647	92057	Luxembourg		92057, EXPIRES: 20251101
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

CAPRELSA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CAPRELSA

Introduction to CAPRELSA

CAPRELSA, also known as vandetanib, is a targeted therapy used for the treatment of aggressive and symptomatic medullary thyroid carcinoma. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global thyroid cancer drugs market, which includes CAPRELSA, is experiencing significant growth. The market is projected to expand from $1.01 billion in 2023 to $1.16 billion in 2024, with a compound annual growth rate (CAGR) of 14.1% expected until 2028, reaching $1.96 billion by then[3][4].

Drug Specifics

CAPRELSA was granted Orphan Drug Designation by the US FDA in 2005 and is currently available in 28 countries. It is part of a segment that includes other targeted therapies such as cabozantinib-s-malate and lenvatinib mesylate[3].

Historical Sales and Revenue

In 2014, CAPRELSA generated global product sales of $48 million. This figure indicates the drug's established presence in the market, although it is part of a broader and growing segment[1].

Divestment and Acquisition

In 2015, AstraZeneca divested CAPRELSA to Genzyme, a Sanofi company, in a deal worth up to $300 million. This included an upfront payment of $165 million and potential milestone payments of up to $135 million. The divestment was part of AstraZeneca's strategy to focus on key disease areas while ensuring continued patient access to the drug[1].

Strategic Fit

The acquisition by Genzyme was seen as a strong strategic fit for their rare endocrinology portfolio. Genzyme's expertise in rare diseases was expected to benefit patients with advanced-stage thyroid carcinoma, highlighting the drug's importance in addressing unmet needs in the thyroid community[1].

Market Drivers

The growth of the thyroid cancer drugs market, including CAPRELSA, is driven by several factors:

• Increasing Prevalence and Aging Population: As the global population ages, the incidence of thyroid cancer is expected to rise.
• Advancements in Precision Medicine: Targeted therapies like CAPRELSA are becoming more prevalent.
• Healthcare Infrastructure Development: Improvements in healthcare infrastructure facilitate better diagnosis and treatment.
• Rising Awareness and Early Detection: Increased awareness and early detection methods contribute to the market's growth[3].

Market Restraints

Despite the growth, there are several restraints to consider:

• High Development Costs: Developing targeted therapies is costly, which can limit market expansion.
• Regulatory Hurdles: Strict regulatory requirements can slow down the approval process for new drugs.
• Competition: The market is competitive, with multiple drugs available for thyroid cancer treatment[3].

Financial Outlook

For companies involved in the development and distribution of CAPRELSA, the financial outlook is influenced by several factors:

• Revenue Streams: The drug generates revenue through sales and potential milestone payments.
• Operating Expenses: Companies like Capricor Therapeutics, which may not be directly involved with CAPRELSA but operate in similar markets, incur significant research and development expenses, as well as general and administrative costs[2].

Regional Market Analysis

The global thyroid cancer drugs market, including CAPRELSA, spans various regions such as Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. Each region presents different market dynamics and growth opportunities[4].

Future Prospects

Given the projected growth of the thyroid cancer drugs market, CAPRELSA is likely to continue playing a significant role. The drug's inclusion in clinical trials and its potential use in combination therapies or biomarker-driven treatments could further enhance its market position[3].

Key Takeaways

• CAPRELSA is a targeted therapy for medullary thyroid carcinoma with a growing market presence.
• The drug was divested from AstraZeneca to Genzyme in 2015 for up to $300 million.
• Market growth is driven by increasing prevalence, advancements in precision medicine, and healthcare infrastructure development.
• Despite growth, the market faces restraints such as high development costs and regulatory hurdles.
• The financial outlook for companies involved is influenced by revenue streams, operating expenses, and regional market dynamics.

FAQs

What is CAPRELSA used for?

CAPRELSA (vandetanib) is used for the treatment of aggressive and symptomatic medullary thyroid carcinoma.

Who acquired CAPRELSA from AstraZeneca?

Genzyme, a Sanofi company, acquired CAPRELSA from AstraZeneca in 2015.

What was the value of the acquisition deal?

The acquisition deal was worth up to $300 million, including an upfront payment of $165 million and potential milestone payments of up to $135 million.

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

Key drivers include increasing prevalence and aging population, advancements in precision medicine, healthcare infrastructure development, and rising awareness and early detection.

What are some of the restraints in the thyroid cancer drugs market?

Restraints include high development costs, regulatory hurdles, and competition from other drugs.

How is the financial outlook for companies involved in the thyroid cancer drugs market?

The financial outlook is influenced by revenue streams from drug sales and milestone payments, as well as significant research and development and general and administrative expenses.

Sources

1. AstraZeneca Press Release: "AstraZeneca further sharpens focus through agreement with Genzyme to divest Caprelsa® (vandetanib), a rare disease medicine."
2. Capricor Therapeutics Financial Results: "Capricor Therapeutics Reports Third Quarter 2024 Financial Results."
3. The Business Research Company Report: "Global Thyroid Cancer Drugs Market Report 2024."
4. PR Newswire: "Thyroid Cancer Drugs Market Set for Remarkable Growth."