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VANFLYTA Drug Patent Profile

Which patents cover Vanflyta, and when can generic versions of Vanflyta launch?

Vanflyta is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are eleven patents protecting this drug.

This drug has one hundred and nineteen patent family members in twenty-nine countries.

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

DrugPatentWatch^® Generic Entry Outlook for Vanflyta

Vanflyta will be eligible for patent challenges on July 20, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 20, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VANFLYTA

International Patents:	119
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	2
Patent Applications:	33
Drug Prices:	Drug price information for VANFLYTA
What excipients (inactive ingredients) are in VANFLYTA?	VANFLYTA excipients list
DailyMed Link:	VANFLYTA at DailyMed

See drug prices for VANFLYTA

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

Constraining patent/regulatory exclusivity:

FOR USE IN COMBINATION WITH STANDARD INDUCTION AND CONSOLIDATION, AND AS MAINTENANCE THERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR THE TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) THAT IS FLT3 INTERNAL TANDEM DUPLICATION (ITD)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST

NDA:

216993

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 VANFLYTA

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

Sponsor	Phase
Daiichi Sankyo, Inc.	Phase 1
Children's Oncology Group	Phase 1/Phase 2
Daiichi Sankyo, Inc.	Phase 1/Phase 2

See all VANFLYTA clinical trials

Pharmacology for VANFLYTA

Drug Class	Kinase Inhibitor
Mechanism of Action	FMS-like Receptor Tyrosine Kinase 3 (FLT3) Inhibitors

US Patents and Regulatory Information for VANFLYTA

VANFLYTA is protected by eleven US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on FOR USE IN COMBINATION WITH STANDARD INDUCTION AND CONSOLIDATION, AND AS MAINTENANCE THERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR THE TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) THAT IS FLT3 INTERNAL TANDEM DUPLICATION (ITD)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST.

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
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-001	Jul 20, 2023		RX	Yes	No	9,585,892
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes	8,129,374
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes	8,557,810		Y
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-001	Jul 20, 2023		RX	Yes	No	8,865,710		Y
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-001	Jul 20, 2023		RX	Yes	No	8,357,690
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-001	Jul 20, 2023		RX	Yes	No
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes	8,865,710		Y

International Patents for VANFLYTA

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	200801021	Imidazolothiazole compounds for the treatment of disease
Lithuania	2429524
New Zealand	596739	Methods of treating proliferative diseases
Canada	2696807	PROCEDES D'ADMINISTRATION DE N-(5-TERT-BUTYL-ISOXAZOL-3-YL)-N'-{4-[7-(2-MORPHOLIN-4-YL-ETHOXY)IMIDAZO[2,1-B][1,3]BENZOTHIAZOL-2-YL]PHENYL}UREE POUR TRAITER UNE MALADIE PROLIFERATIVE (METHODS OF ADMINISTERING N-(5-TERT-BUTYL-ISOXAZOL-3-YL)-N'-{4-[7-(2-MORPHOLIN-4-YL-ETHOXY)IMIDAZO[2,1-B][1,3]BENZOTHIAZOL-2-YL]PHENYL}UREA TO TREAT PROLIFERATIVE DISEASE)
China	101835472	Methods of administering N-(5-tert-butyl-isoxazol-3-yl)-N'-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea to treat proliferative disease
Russian Federation	2008141169	СОЕДИНЕНИЯ ИМИДАЗОЛОТИАЗОЛА ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ
Poland	2001892

Supplementary Protection Certificates for VANFLYTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2429524	PA2024510	Lithuania		PRODUCT NAME: KVIZARTINIBAS; REGISTRATION NO/DATE: EU/1/23/1768 20231106
2429524	CA 2024 00013	Denmark		PRODUCT NAME: QUIZARTINIB; REG. NO/DATE: EU/1/23/1768 20231107
2429524	301265	Netherlands		PRODUCT NAME: QUIZARTINIB; REGISTRATION NO/DATE: EU/1/23/1768 20231107

VANFLYTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vanflyta

Introduction to Vanflyta

Vanflyta, formerly known as quizartinib, is a significant advancement in the treatment of acute myeloid leukemia (AML), particularly for patients with FLT3-ITD mutations. Developed by Daiichi Sankyo, this drug has recently gained approval in the U.S. after initial success in Japan.

FDA Approval and Market Entry

After a four-year wait following its initial rejection by the FDA, Vanflyta has secured U.S. approval. This approval is based on the results of the QuANTUM-First trial, which demonstrated that Vanflyta, when used in conjunction with standard chemotherapy and as a maintenance monotherapy, reduced the risk of death by 22% compared to standard chemotherapy alone[1].

Competitive Landscape

The AML treatment market is highly competitive, with established players like Novartis and Astellas Pharma already present. Novartis’ Rydapt and Astellas’ Xospata have been on the market for some time, targeting the same FLT3 gene mutations. However, Vanflyta’s approval across three phases of treatment (induction, consolidation, and maintenance) could be a differentiating factor, helping it to carve out a niche in this competitive space[1].

Global FLT3 Inhibitors Market

The global FLT3 inhibitors market is projected to grow significantly, with a Compound Annual Growth Rate (CAGR) of 10.87% from 2020 to 2032. North America, driven by the U.S. and Canadian markets, is the largest shareholder in this market and is expected to continue its dominance due to high acceptance rates and substantial investments in research and development[4].

Financial Performance of Daiichi Sankyo

Daiichi Sankyo’s financial performance has been robust, with significant increases in revenue and core operating profit. For the FY2023 Q2 period, the company reported a revenue increase of 25.5% year-over-year, driven partly by the success of its oncology products, including Enhertu and other key therapies. The company’s core operating profit also saw a notable increase, reflecting the positive impact of its strategic investments and product portfolio[2].

Revenue Contribution from Vanflyta

While specific revenue figures for Vanflyta are not yet fully disclosed, its approval and market entry are expected to contribute significantly to Daiichi Sankyo’s oncology segment. Given that Vanflyta is the only Type 2 FLT3 inhibitor commercialized in Japan and now approved in the U.S., it is poised to generate substantial revenue, particularly as it gains market traction and patient acceptance[4].

R&D and Strategic Investments

Daiichi Sankyo has been investing heavily in research and development, with R&D expenses increasing by 12.2% in the FY2023 Q2 period compared to the previous year. These investments are crucial for the development of new therapies, including Vanflyta, and for maintaining a competitive edge in the pharmaceutical market[2].

Market Share and Patient Impact

Vanflyta’s approval is particularly significant for patients with FLT3-ITD AML, who have a five-year survival rate of approximately 20%. The drug’s ability to reduce mortality risk by 22% offers a promising treatment option for these patients. As Vanflyta gains market share, it is likely to improve the lives of many AML patients, contributing to Daiichi Sankyo’s reputation as a leader in oncology treatments[1].

Regional Market Dynamics

North America, particularly the U.S., is expected to be a key market for Vanflyta. The region’s high acceptance rate for new therapies and significant investments in cancer research will drive the adoption of Vanflyta. Europe is also anticipated to be a fast-growing market, further expanding the drug’s global reach[4].

Challenges and Opportunities

Despite the positive outlook, Vanflyta faces challenges in a competitive market. The drug must differentiate itself through its unique treatment phases and clinical outcomes to gain preference over existing treatments. However, with strong clinical data and strategic marketing, Vanflyta has the potential to become a leading treatment option for AML patients with FLT3-ITD mutations.

Financial Projections

Daiichi Sankyo’s financial projections indicate continued growth, with core operating profit expected to increase by 15% in the FY2023 forecast. The success of Vanflyta, along with other key products like Enhertu, will be crucial in achieving these financial targets. The company’s ability to manage costs, particularly in areas like SG&A expenses, will also be important for maintaining profitability[2].

Conclusion

Vanflyta’s entry into the U.S. market marks a significant milestone for Daiichi Sankyo and for the treatment of AML. With its unique approval across three treatment phases and strong clinical data, Vanflyta is poised to make a substantial impact on patient outcomes and the company’s financial trajectory.

Key Takeaways

• FDA Approval: Vanflyta has been approved in the U.S. for treating AML patients with FLT3-ITD mutations.
• Competitive Landscape: Vanflyta competes with established drugs like Rydapt and Xospata but differentiates itself through its three-phase treatment approval.
• Global Market: The global FLT3 inhibitors market is growing, with North America being the largest market.
• Financial Performance: Daiichi Sankyo’s revenue and core operating profit are expected to grow, partly due to Vanflyta’s success.
• R&D Investments: Significant investments in R&D are crucial for Vanflyta’s development and market success.
• Patient Impact: Vanflyta offers improved survival rates for AML patients with FLT3-ITD mutations.

FAQs

Q: What is Vanflyta, and how is it used in treating AML? A: Vanflyta (quizartinib) is a second-generation Type 2 tyrosine kinase inhibitor used to treat acute myeloid leukemia (AML) patients with FLT3-ITD mutations. It is approved for use in conjunction with standard chemotherapy and as a maintenance monotherapy.

Q: What were the key findings of the QuANTUM-First trial? A: The QuANTUM-First trial showed that Vanflyta, when used with chemotherapy and as a maintenance monotherapy, reduced the risk of death by 22% compared to standard chemotherapy alone.

Q: How does Vanflyta differentiate itself in the competitive AML treatment market? A: Vanflyta differentiates itself through its approval across three phases of treatment (induction, consolidation, and maintenance), which sets it apart from other FLT3 inhibitors like Rydapt and Xospata.

Q: What is the projected growth of the global FLT3 inhibitors market? A: The global FLT3 inhibitors market is expected to grow at a CAGR of 10.87% from 2020 to 2032, with North America being the largest market.

Q: How has Daiichi Sankyo’s financial performance been impacted by the approval of Vanflyta? A: While specific figures for Vanflyta are not yet disclosed, the drug’s approval is expected to contribute significantly to Daiichi Sankyo’s revenue and core operating profit, given the company’s overall strong financial performance in the oncology segment.

Sources

1. Fierce Pharma: "Daiichi scores FDA nod for leukemia med Vanflyta - Fierce Pharma"
2. Daiichi Sankyo: "FY2023 Q2 Financial Results Presentation"
3. Daiichi Sankyo: "FY2023 Q1 Financial Results Presentation"
4. Straits Research: "Global FLT3 Inhibitors Market Size, Top Share, Report to 2032"