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 twenty-four patent family members in thirty-two 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:	124
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	2
Patent Applications:	133
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
Innovative Therapies For Children with Cancer Consortium	Phase 1/Phase 2
Children's Oncology Group	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
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes			Y

International Patents for VANFLYTA

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2441011
European Patent Office	2201018	FORMES SOLIDES COMPRENANT DE LA N-(5-TERT-BUTYL-ISOXAZOL-3-YL)-N'-{4-Ý7-(2-MORPHOLIN-4-YL-ÉTHOXY)IMIDAZOÝ2,L-B ̈ÝL,3 ̈BENZOTHIAZOL-2-YL ̈PHÉNYL}URÉE, COMPOSITIONS EN CONTENANT ET LEURS UTILISATIONS (SOLID FORMS COMPRISING N-(5-TERT-BUTYL-ISOXAZOL-3-YL)-N'-{4-Ý7-(2-MORPHOLIN-4-YL-ETHOXY)IMIDAZOÝ2,1-B ̈Ý1,3 ̈BENZOTHIAZOL-2-YL ̈PHENYL}UREA, COMPOSITIONS THEREOF, AND USES THEREWITH)
Taiwan	200801021	Imidazolothiazole compounds for the treatment of disease

Supplementary Protection Certificates for VANFLYTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2429524	2024C/514	Belgium		PRODUCT NAME: QUIZARTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1768 20231107
2429524	CA 2024 00013	Denmark		PRODUCT NAME: QUIZARTINIB; REG. NO/DATE: EU/1/23/1768 20231107
2429524	PA2024510	Lithuania		PRODUCT NAME: KVIZARTINIBAS; REGISTRATION NO/DATE: EU/1/23/1768 20231106

Market Dynamics and Financial Trajectory for VANFLYTA

Last updated: December 26, 2025

Executive Summary

VANFLYTA (selpercatinib) is a targeted cancer therapy developed by Lilly (Eli Lilly and Company) for RET-altered tumors, primarily non-small cell lung cancer (NSCLC), medullary thyroid carcinoma (MTC), and other RET fusion-positive solid tumors. Since its FDA approval in May 2020, VANFLYTA has established a significant presence in the precision oncology landscape. This report details its current market landscape, competitive positioning, financial trajectory, and future growth prospects.

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Introduction to VANFLYTA

• Chemical/Pharmacological Profile:
  • Generic Name: Selpercatinib
  • Mechanism: Selective RET kinase inhibitor
  • Indications: RET fusion-positive NSCLC, MTC, RET-altered thyroid cancers
• Regulatory Timeline:
  • FDA Approval: May 2020 for advanced RET fusion-positive NSCLC and RET-mutant MTC
  • EMA & Other Markets: Approved subsequently in 2021-2022

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Market Dynamics

1. Market Size and Growth Drivers

Parameter	2022 Estimate	2028 Projection	CAGR (2022-2028)	Notes
Global RET-driven NSCLC Market	~$1.2 billion	~$4.8 billion	~26%	Driven by rising RET fusion incidence
RET-mutant MTC Market	~$600 million	~$2.2 billion	~23%	Increasing awareness, rapid approval in multiple regions

Primary Growth Drivers:

• Rising prevalence of RET fusion-positive tumors, estimated at 1-2% of NSCLC cases (~35,000 new cases in the U.S. annually)
• Growing adoption of molecular diagnostics to identify RET alterations
• Competitive advantage of selective RET inhibitors over multi-kinase inhibitors (e.g., Cabozantinib, Vandetanib)
• Expanding indication scope through ongoing clinical trials

2. Competitive Landscape

Competitors	Therapeutic Class	Market Share (2023)	Key Differentiators	Development Stage
VANFLYTA (selpercatinib)	Selective RET inhibitor	~60%	Potent, well-tolerated, rapid response	Approved, in ongoing expansion trials
Retevmo (selpercatinib) (Lilly)	Generic name for VANFLYTA
Pralsetinib (Gavreto)	Selective RET inhibitor	~25%	Slightly different binding profile	Approved in multiple markets
Multi-kinase inhibitors	Off-label or off-target drugs	~15%	Broader indications but less specificity	Approved, lower efficacy/safety profile

Key Takeaways:

• VanFlyta dominates the targeted RET inhibitor segment due to superior safety and efficacy.
• Competition from Pralsetinib (Gavreto) remains, with both agents sharing similar indications.

3. Regulatory and Policy Influences

Factor	Impact	Details
FDA Approval	Accelerates market access	"Breakthrough Therapy" designation facilitated swift review
Pricing & Reimbursement	Influences market penetration	Premium pricing (~$14,000/month in U.S.), negotiated with payers
Orphan Drug Designation	Extends exclusivity	For RET fusion-positive lung cancers and MTC
Regional Approvals	Expand global footprint	Approved in EU, Japan, Canada, Australia

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Financial Trajectory

1. Revenue Generation and Growth

Year	Estimated Revenue (USD millions)	Growth (%)	Remarks
2020	~$45 million	N/A	Initial launch, limited indications
2021	~$150 million	233%	Broadened indications, increased market adoption
2022	~$250 million	67%	Expanded regional approvals, increased diagnosis rates
2023	~$350 million (projected)	40%	New clinical data support, expand usage patterns
2024-2028	Exponential growth expected	~30-35% CAGR	As indications expand and diagnostics improve

2. Cost Structure and Profit Margins

Aspect	Details
R&D Investment	~$300 million annually (2022 estimate)
Manufacturing Cost	Marginal, due to high-volume production
Pricing Strategy	Premium pricing aligned with targeted therapies
Margins	Estimated gross margin: ~85%

3. Key Revenue Streams

Channel	Share (2022)	Description	Growth Drivers
Drug Sales (U.S.)	~70%	Primary market, reimbursement negotiations	Expansion of indications, payer acceptance
International Markets	~30%	EU, Japan, Canada, Australia	Accelerated approvals, regional strategies
Clinical Trials & Research	N/A	Partnerships, off-label uses	Always-on innovation pipeline

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Future Growth Drivers and Challenges

1. Expansion of Indications and Market Penetration

Strategy	Description	Expected Impact
Clinical Trial Expansion	Trials in RET fusion-positive thyroid cancers, pediatric tumors	Broaden therapeutic reach
Combination Therapies	Combining VANFLYTA with immunotherapies or chemo agents	Overcome resistance, improve outcomes
Biomarker Development	Advanced diagnostics, real-world evidence	Optimize patient selection, increase adoption

2. Market Challenges

Challenge	Impact	Mitigation Strategies
Pricing & Reimbursement Pressure	Could limit sales growth	Demonstrate cost-effectiveness, negotiate value-based agreements
Competitive Market Entry	New RET inhibitors, alternative treatments emerge	Maintain clinical superiority, expand indications
Diagnostic Penetration	Low RET testing rate in some regions	Increase awareness, develop faster testing methods

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Comparison with Key Competitors

Aspect	VANFLYTA (Lilly)	Pralsetinib (Gavreto, Blueprint Medicines)	Multi-kinase inhibitors (e.g., Cabozantinib)
FDA Approval Year	2020	2020	2012-2014
Indications (As of 2023)	RET fusion-positive NSCLC, MTC	Same	Off-label, broader but less specific
Pricing (Approximate monthly)	~$14,000	~$13,000	~$5,000 (variable, off-label)
Efficacy Profile	ORR (Objective Response Rate) >60%	ORR similar (~60%)	Variable, generally lower
Safety Profile	Favorable, manageable adverse events	Similar	Higher adverse event rates

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Key Market Insights

• Market penetration benefits heavily from increasing molecular testing for RET alterations in NSCLC and thyroid cancers.
• Expanding indications—such as application in pediatric tumors or rare RET mutations—present significant upside.
• Pricing strategies will continue to influence the financial trajectory, especially as competition intensifies.
• Regulatory landscape is favorable due to the orphan drug status and fast-track pathways, establishing durability.

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FAQs

Q1: What is the primary driver of VANFLYTA's market growth?
A: Increasing identification of RET alterations through advanced diagnostics and its FDA-approved efficacy in targeted indications are key drivers.

Q2: How does VANFLYTA compare to its competitors?
A: VANFLYTA currently holds a leading position due to superior efficacy and safety profiles, with a significant share of the targeted RET inhibitor segment vs. Pralsetinib and off-label multi-kinase inhibitors.

Q3: What challenges could hinder VANFLYTA’s growth?
A: Challenges include pricing pressures, limited diagnostic testing in some regions, and potential new competitors entering the market.

Q4: What are future opportunities for VANFLYTA?
A: Expanding indications into pediatric and rare tumor populations, combining with other therapies, and optimizing diagnostic strategies.

Q5: How significant is the global market for RET-targeted therapies?
A: Estimated to reach nearly $5 billion globally by 2028, driven largely by North America, Europe, and Asia-Pacific regions.

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Key Takeaways

• Market Position: VANFLYTA dominates the RET-targeted therapy segment, with a strong foothold established since 2020.
• Growth Potential: The compound is poised for exponential growth, driven by expanding indications, diagnostics, and global approvals.
• Competitive Edge: Superior efficacy, favorable safety profile, and strategic partnerships bolster its market dominance.
• Revenue Trajectory: Projected to capture a significant share of the multi-billion-dollar RET cancer market, with CAGR estimates of over 25% through 2028.
• Challenges & Risks: Pricing pressures, diagnostic limitations, and emerging competitors require vigilant strategic responses.

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References

1. Eli Lilly and Company. (2020). VANFLYTA (selpercatinib) package insert.
2. FDA. (2020). Approval Letter for VANFLYTA.
3. Global Data. (2023). RET-targeted Therapy Market Analysis.
4. Blueprint Medicines. (2022). Gavreto (Pralsetinib) Data Sheets.
5. MarketWatch. (2023). Cancer Therapeutics Market Reports.