RIPRETINIB - Generic Drug Details

What are the generic drug sources for ripretinib and what is the scope of patent protection?

Ripretinib is the generic ingredient in one branded drug marketed by Deciphera Pharms and is included in one NDA. There are forty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ripretinib has one hundred and fourteen patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for RIPRETINIB

International Patents:	114
US Patents:	41
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	13
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RIPRETINIB
What excipients (inactive ingredients) are in RIPRETINIB?	RIPRETINIB excipients list
DailyMed Link:	RIPRETINIB at DailyMed

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

Constraining patent/regulatory exclusivity:

11,185,535

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 RIPRETINIB

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

Sponsor	Phase
Asan Medical Center	PHASE1
Pfizer	Phase 1/Phase 2
Asan Medical Center	Phase 2

See all RIPRETINIB clinical trials

Pharmacology for RIPRETINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C8 Inhibitors P-Glycoprotein Inhibitors Platelet-derived Growth Factor alpha Receptor Inhibitors Stem Cell Factor (KIT) Receptor Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RIPRETINIB

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

US Patents and Regulatory Information for RIPRETINIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes	11,529,336
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes	11,534,432
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes	12,023,325

EU/EMA Drug Approvals for RIPRETINIB

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Deciphera Pharmaceuticals (Netherlands) B.V.	Qinlock	ripretinib	EMEA/H/C/005614Qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.	Authorised	no	no	yes	2021-11-18

International Patents for RIPRETINIB

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	016055
Australia	2023241368	Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea
China	119970649	非晶型激酶抑制剂制剂及其使用方法 (Amorphous kinase inhibitor formulations and methods of use thereof)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Ripretinib

Last updated: July 30, 2025

Introduction

Ripretinib, marketed under the brand name QINLOCK, is a targeted kinase inhibitor developed by Deciphera Pharmaceuticals. Approved by the U.S. Food and Drug Administration (FDA) in May 2020 for the treatment of gastrointestinal stromal tumors (GIST) in adults who have received prior treatment with three or more kinase inhibitors, ripretinib has emerged as a significant advancement in oncology therapeutics. This analysis explores the evolving market landscape, competitive positioning, revenue projections, and strategic considerations shaping ripretinib's financial trajectory.

Market Overview and Demand Drivers

The global oncology therapeutics market is experiencing exponential growth driven by rising cancer incidence, advancements in molecular diagnostics, and increasing adoption of targeted therapies. Specifically, GIST accounts for approximately 1-3% of all sarcomas [1], with an estimated annual incidence of approximately 4,000 to 5,000 cases in the United States alone. Patients with advanced GIST typically undergo multiple lines of treatment, including imatinib, sunitinib, and regorafenib, rendering them candidates for newer agents such as ripretinib.

The prevailing unmet need is substantial. Despite existing therapies, resistance frequently develops, necessitating effective third-line options. Ripretinib’s unique mechanism of action—as a switch-control kinase inhibitor targeting KIT and PDGFRA mutations—addresses this resistance, positioning it as a vital asset in the treatment paradigm.

Market Dynamics

Competitive Landscape

The competitive environment is characterized by a handful of targeted agents approved for GIST. Imatinib was the first-line standard of care, with regorafenib and sunitinib serving as approved second- and third-line options. The introduction of ripretinib expanded therapeutic choices, primarily for patients refractory to existing treatments.

However, potential competition remains, including emerging therapies and biosimilars entering the market. Notably, avapritinib (AYVAKYT) and other next-generation kinase inhibitors are in development stages or have gained approval for specific mutations. The pipeline activity suggests a gradual intensification of competition, which could influence ripretinib's market share.

Regulatory and Reimbursement Environment

Regulatory approvals in major markets such as the U.S., EU, and Japan underpin ripretinib’s commercial prospects. The FDA granted accelerated approval based on tumor response rates, with confirmatory trials ongoing. Reimbursement policies are evolving; coverage by key payers is generally positive due to the drug’s confirmed clinical benefit in refractory GIST.

Price positioning is critical. Ripretinib’s list price in the U.S. is comparable to other targeted oncology agents, typically ranging between $10,000 and $15,000 per month [2]. Payer negotiations and formulary placements will significantly influence sales volume.

Market Penetration Strategies

Deciphera’s focus on expanding access through strategic partnerships, educational initiatives, and real-world evidence collection is essential. Additionally, geographic expansion into Europe and Asia, where GIST prevalence and unmet needs are substantial, offers growth opportunities.

Financial Trajectory

Revenue Projections

Analyzing the financial outlook requires assumptions regarding market penetration rates, pricing, and competitive dynamics. Based on existing data:

• Initial Year (2020-2021): Post-approval, ripretinib generated approximately $100 million globally, primarily in North America, reflecting rapid adoption among refractory GIST patients [3].

• Mid-Term (2022-2025): With expanded approval in additional markets and increased awareness, revenues are projected to grow at a compounded annual growth rate (CAGR) of approximately 20-25%. This could translate to revenues approaching $500 million by 2025, contingent on market share adoption.

• Long-Term (2026 onward): Market saturation and potential competition could stabilize or slightly reduce growth rates. However, ongoing clinical trials exploring ripretinib’s efficacy in other indications—such as systemic mastocytosis and other solid tumors—may diversify revenue streams, adding new facets to the financial picture.

Cost Structure and Profitability Considerations

Development costs for ripretinib were substantial, with Deciphera investing heavily in clinical development and commercialization. Post-approval, the key financial considerations involve manufacturing expenses, marketing, distribution, and ongoing R&D. Gross margins are expected to be high due to the nature of specialty pharmaceuticals; however, cost pressures from payer negotiations could impact net profitability.

Risks and Challenges

• Market Penetration Risks: Limited commercial outreach or regulatory hurdles could constrain uptake.
• Competitive Threats: Innovations from pipeline drugs or biosimilars may erode market share.
• Clinical Development Risks: Pending results from confirmatory trials could influence perception and utilization.
• Pricing and Reimbursement: Payer pushback on premium pricing could impede revenue growth.

Strategic Outlook

Deciphera’s strategic focus on expanding indications and geographic reach is essential. Formulary positioning within major healthcare systems, advocacy for reimbursement, and evidence generation are pivotal pillars. In addition, exploring companion diagnostics and personalized medicine approaches could optimize patient selection and enhance market share.

Key Trends Influencing Future Financial Trajectory

• Global Oncology Market Growth: Expected CAGR of 7.6% through 2027, bolstering demand for targeted therapies [4].
• Advances in Molecular Diagnostics: Improved mutation profiling enables tailored use of ripretinib.
• Emergence of Combination Regimens: Potential approvals for combination therapies may expand treatment options, influencing ripretinib’s role.

Conclusion

Ripretinib’s market dynamics are primarily shaped by its innovative mechanism, unmet need in refractory GIST, and evolving competitive landscape. Its promising financial trajectory hinges on effective commercialization, broader indication approvals, and navigating reimbursement channels. While challenges persist, strategic positioning and ongoing clinical developments portend a resilient growth outlook within the targeted oncology therapeutic space.

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Key Takeaways

• Market Opportunity: Significant unmet need in third-line GIST treatment positions ripretinib favorably in a niche yet growing market.
• Revenue Potential: Projected to reach up to $500 million globally within five years, with expansion into new markets and indications.
• Competitive Environment: Increasing pipeline activity and emerging therapies necessitate strategic innovation and differentiation.
• Regulatory and Reimbursement Factors: Critical for sustaining revenue growth; proactive engagement with payers and regulators is essential.
• Strategic Focus: Geographic expansion, indication diversification, and real-world evidence generation are key drivers of long-term financial success.

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FAQs

1. What makes ripretinib distinct from other GIST treatments?
Ripretinib uniquely acts as a switch-control kinase inhibitor targeting multiple KIT and PDGFRA mutations responsible for resistance in GIST, providing an effective third-line treatment option where earlier therapies fail.

2. What is the current regulatory status of ripretinib outside the U.S.?
As of 2023, ripretinib has received approval in several markets, including the European Union and Japan, expanding its availability. Regulatory timelines vary depending on regional review processes.

3. How does the competitive landscape affect ripretinib’s market share?
Emerging therapies and pipeline drugs pose a competitive threat, especially as new molecular diagnostics enable more personalized approaches, potentially reducing ripretinib’s market dominance unless it maintains efficacy advantages.

4. What are the key risk factors for ripretinib’s financial growth?
Major risks include regulatory delays, reimbursement challenges, market saturation, and the emergence of superior treatments in development.

5. What future indications could enhance ripretinib’s market potential?
Clinical trials exploring ripretinib’s efficacy in systemic mastocytosis and broader solid tumor indications could diversify revenue streams and extend its market life.

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References

[1] Fletcher, C. D., et al. (2015). "WHO Classification of Tumours of Soft Tissue and Bone." WHO, 4th Edition.

[2] Deciphera Pharmaceuticals. (2022). “QINLOCK (ripretinib) Pricing and Reimbursement.” Company Reports.

[3] EvaluatePharma. (2021). “Global Oncology Market Trends.”

[4] Grand View Research. (2022). “Oncology Drugs Market Size, Share & Trends.”