Cabozantinib s-malate - Generic Drug Details

What are the generic sources for cabozantinib s-malate and what is the scope of freedom to operate?

Cabozantinib s-malate is the generic ingredient in two branded drugs marketed by Exelixis and Exelixis Inc, and is included in two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabozantinib s-malate has two hundred and thirty-four patent family members in thirty-two countries.

Summary for cabozantinib s-malate

International Patents:	234
US Patents:	12
Tradenames:	2
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	42
Patent Applications:	1,299
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cabozantinib s-malate
DailyMed Link:	cabozantinib s-malate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cabozantinib s-malate

Constraining patent/regulatory exclusivity:

9,717,720

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

11,298,349

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 cabozantinib s-malate

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

Sponsor	Phase
Emory University	Phase 2
Children's Oncology Group	Phase 2/Phase 3
National Cancer Institute (NCI)	Phase 2/Phase 3

See all cabozantinib s-malate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for cabozantinib s-malate

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

Paragraph IV (Patent) Challenges for CABOZANTINIB S-MALATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CABOMETYX	Tablets	cabozantinib s-malate	20 mg, 40 mg and 60 mg	208692	1	2019-08-16

US Patents and Regulatory Information for cabozantinib s-malate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016		RX	Yes	Yes	8,877,776		Y	Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016		RX	Yes	No	11,091,440		Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016		RX	Yes	Yes	11,098,015
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-002	Nov 29, 2012		RX	Yes	Yes	7,579,473		Y	Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016		RX	Yes	No	10,039,757
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016		RX	Yes	No	11,298,349		Y

Expired US Patents for cabozantinib s-malate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016	8,497,284
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016	8,497,284
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016	8,497,284

International Patents for cabozantinib s-malate

Country	Patent Number	Title	Estimated Expiration
Slovenia	2387563
Australia	2013204031	c-Met modulators and methods of use
Portugal	2387563
South Korea	20200137052	암의 치료를 위한 Ｎ-（４-｛〔６，７-비스（메틸옥시）퀴놀린-4-일〕옥시｝페닐）-Ｎ＇-（４-플루오로페닐）사이클로프로판-1,1-디카르복사미드의 말산염 및 그 결정형 (----4-----11- MALATE SALT OF N-4-[67-BISMETHYLOXYQUINOLIN-4-YL]OXYPHENYL-N'-4-FLUOROPHENYLCYCLOPROPANE-11-DICARBOXAMIDE AND CRYSTALLINE FORMS THEREOF FOR THE TREATMENT OF CANCER)
Japan	2016188216	キノリン化合物およびそのような化合物を含有する医薬組成物の調製方法 (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
Japan	2021191756	Ｎ−（４−｛［６，７−ビス（メチルオキシ）キノリン−４−イル］オキシ｝フェニル）−Ｎ’−（４−フルオロフェニル）シクロプロパン−１，１−ジカルボキサミドのリンゴ酸塩およびその結晶質形態 (N-(4-{[6,7-BIS(METHYLOXY)-QUINOLINE-4-YL]OXY}PHENYL)-N'-(4-FLUOROPHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE MALATE AND CRYSTALLINE FORM THEREOF)

Supplementary Protection Certificates for cabozantinib s-malate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213661	C02213661/01	Switzerland		PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66471 15.12.2017
2213661	2014/052	Ireland		PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326
2213661	132014902289810	Italy		PRODUCT NAME: CABOZANTINIB(COMETRIQ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/890/001,002,003, 20140326
2213661	583	Finland
2213661	300678	Netherlands		PRODUCT NAME: CABOZANTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326
2213661	220 50007-2014	Slovakia		PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140326

Market Dynamics and Financial Trajectory for Cabozantinib S-Malate

Introduction

Cabozantinib s-malate, a kinase inhibitor, has been a significant player in the oncology market, particularly in the treatment of various types of cancer. This article delves into the market dynamics and financial trajectory of this drug, highlighting its approval, usage, cost-effectiveness, and future prospects.

Approval and Indications

Cabozantinib s-malate is approved for several indications, including differentiated thyroid cancer, hepatocellular carcinoma, medullary thyroid cancer, and renal cell carcinoma. These approvals have been granted by regulatory bodies such as the FDA and the European Medicines Agency (EMA)[2][5].

Mechanism of Action

Cabozantinib s-malate works by blocking proteins that signal cancer cells to divide and new blood vessels to grow, thereby inhibiting tumor growth and spread. This targeted therapy approach has made it a valuable treatment option in oncology[5].

Market Position

The drug is marketed under different brand names, including Cabometyx and Cometriq, depending on the indication. Its market position is strengthened by its unique mechanism of action and the unmet medical needs it addresses, particularly in patients who have progressed after prior therapies[2][5].

Cost and Cost-Effectiveness

The cost of cabozantinib s-malate is substantial, with a price of $301.2943 per tablet or $8,436 per 28-day cycle. Cost-utility analyses have shown varying results regarding its cost-effectiveness. For instance, a Canadian analysis indicated an incremental cost-effectiveness ratio (ICER) of $206,389 per quality-adjusted life year (QALY) gained compared to best supportive care (BSC) alone. However, this ICER can vary significantly based on the assumptions used in the analysis, such as the extrapolation models for overall survival (OS) and health state utilities[1].

Financial Implications

The financial viability of cabozantinib s-malate is influenced by several factors, including its comparative added clinical benefit, market sales, and the costs associated with its development and administration. The drug has shown high early market sales, particularly in the oncology cohort, where it has outperformed other therapeutic areas. For example, oncology drugs like cabozantinib s-malate have average cumulative sales of $1,041 million over nine quarters post-launch, significantly higher than other drug cohorts[3].

Clinical Trials and Development

Cabozantinib s-malate is continuously being studied in various clinical trials to expand its indications and improve treatment outcomes. Currently, it is in Phase II trials for neuroendocrine cancer, with a phase transition success rate (PTSR) benchmark of 34% for progressing into Phase III[4].

Market Rewards for Comparative Added Clinical Benefit

The market tends to reward drugs with higher comparative added clinical benefit scores, and cabozantinib s-malate is no exception. Its significant clinical benefits in treating advanced cancers have translated into strong market performance and financial returns[3].

Regulatory and Public Health Impact

The EMA granted an accelerated assessment for cabozantinib s-malate due to its major public health interest, highlighting its positive benefit-risk balance and the comprehensive data provided by the applicant. This accelerated approval process reflects the drug's potential to address unmet medical needs and its impact on medical practice[2].

Sensitivity and Scenario Analyses

Sensitivity and scenario analyses have been conducted to assess the robustness of the cost-effectiveness estimates. These analyses have shown that the ICER can vary widely based on different assumptions, such as the choice of OS extrapolation models and health state utility values. For instance, using a single exponential model to extrapolate OS data post-trial resulted in a significantly higher ICER of $281,727[1].

Future Prospects

Given its current market performance and ongoing clinical trials, cabozantinib s-malate is poised for continued growth. The drug's likelihood of approval for new indications, such as neuroendocrine cancer, will further expand its market reach. GlobalData's analysis suggests that the drug-specific phase transition and likelihood of approval scores are critical in predicting its future success[4].

Conclusion

Cabozantinib s-malate has established itself as a valuable treatment option in the oncology market, with significant clinical benefits and a strong financial trajectory. Its cost-effectiveness, while subject to various assumptions, underscores the need for careful economic evaluations. As the drug continues to be studied in new indications and its market position evolves, it is likely to remain a major player in the treatment of advanced cancers.

Key Takeaways

• Approval and Indications: Cabozantinib s-malate is approved for several types of cancer, including differentiated thyroid cancer, hepatocellular carcinoma, medullary thyroid cancer, and renal cell carcinoma.
• Cost and Cost-Effectiveness: The drug is expensive, with an ICER that can vary significantly based on the analysis assumptions.
• Market Performance: It has strong early market sales, particularly in the oncology cohort.
• Clinical Trials: Ongoing trials aim to expand its indications, including a Phase II trial for neuroendocrine cancer.
• Regulatory Impact: Accelerated approval reflects its major public health interest and positive benefit-risk balance.
• Future Prospects: Continued growth is expected, driven by new indications and strong market performance.

FAQs

Q: What is cabozantinib s-malate used for? A: Cabozantinib s-malate is used to treat various types of cancer, including differentiated thyroid cancer, hepatocellular carcinoma, medullary thyroid cancer, and renal cell carcinoma.

Q: How does cabozantinib s-malate work? A: It works by blocking proteins that signal cancer cells to divide and new blood vessels to grow, thereby inhibiting tumor growth and spread.

Q: What is the cost of cabozantinib s-malate? A: The cost is $301.2943 per tablet or $8,436 per 28-day cycle.

Q: Is cabozantinib s-malate cost-effective? A: The cost-effectiveness varies based on the analysis assumptions, with ICERs ranging from $206,389 to $281,727 per QALY gained.

Q: What are the future prospects for cabozantinib s-malate? A: The drug is expected to continue growing, driven by ongoing clinical trials and potential new indications, such as neuroendocrine cancer.

Sources

1. NCBI: Pharmacoeconomic Review - Cabozantinib (Cabometyx)[1].
2. EMA: CHMP assessment report - CABOMETYX[2].
3. ASPE: Antimicrobial Drugs Market Returns Analysis[3].
4. Pharmaceutical Technology: Cabozantinib s-malate by Ipsen for Neuroendocrine Cancer[4].
5. NCI: Cabozantinib-S-Malate[5].