QINLOCK Drug Patent Profile

Which patents cover Qinlock, and what generic alternatives are available?

Qinlock is a drug marketed by Deciphera Pharms and is included in one NDA. There are forty-one patents protecting this drug.

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

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

DrugPatentWatch^® Generic Entry Outlook for Qinlock

Qinlock was eligible for patent challenges on May 15, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 30, 2040. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for QINLOCK

International Patents:	114
US Patents:	41
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	1
Patent Applications:	366
Drug Prices:	Drug price information for QINLOCK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QINLOCK
What excipients (inactive ingredients) are in QINLOCK?	QINLOCK excipients list
DailyMed Link:	QINLOCK at DailyMed

See drug prices for QINLOCK

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

Constraining patent/regulatory exclusivity:

11,185,535

NDA:

213973

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 QINLOCK

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

Sponsor	Phase
Deciphera Pharmaceuticals LLC	Phase 1

See all QINLOCK clinical trials

Pharmacology for QINLOCK

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

US Patents and Regulatory Information for QINLOCK

QINLOCK is protected by forty-one US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,185,535.

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
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes	11,911,370		Y
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes	8,188,113		Y	Y
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes	11,576,903		Y
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes	8,461,179		Y	Y

EU/EMA Drug Approvals for QINLOCK

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 QINLOCK

When does loss-of-exclusivity occur for QINLOCK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Mexico

Poland

Portugal

San Marino

Serbia

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QINLOCK around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	4084778
Mexico	2009002813
Brazil	112022013109	FORMULAÇÕES DE INIBIDOR DE QUINASE AMORFO E MÉTODOS DE USO DAS MESMAS
Japan	2022544778	脊椎配向システム

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: QINLOCK

Last updated: July 27, 2025

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Introduction

QINLOCK (ripretinib) emerges as a targeted therapy for advanced gastrointestinal stromal tumors (GIST), a rare mesenchymal neoplasm primarily arising in the stomach or small intestine. Approved by the U.S. Food and Drug Administration (FDA) in 2020 for the treatment of adults with advanced GIST who have received prior systemic therapy, QINLOCK represents a significant advancement in the oncological landscape[1]. This analysis delineates the market dynamics influencing QINLOCK's trajectory and assesses its financial outlook within the broader pharmaceutical ecosystem.

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Market Size and Unmet Need

GIST accounts for approximately 1-3% of all gastrointestinal tumors, with an estimated incidence of 10-15 cases per million annually[2]. Despite its rarity, the disease's targeted treatment regimen sustains a significant unmet medical need, especially for patients with advanced, refractory disease. The current standard of care primarily involves tyrosine kinase inhibitors (TKIs) such as imatinib, sunitinib, and regorafenib. However, resistance develops over time, rendering these therapies less effective and underscoring the necessity for novel agents like QINLOCK[3].

The initial market potential is constrained by the rarity of the condition, but the high therapeutic value and expansion into earlier lines of therapy bolster revenue prospects.

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Market Dynamics Influencing QINLOCK

1. Competitive Landscape

QINLOCK's arrival introduced a new class of mutation-specific inhibitors aimed at overcoming resistance to first-line TKIs. While drugs like imatinib dominate early treatment, second- and third-line options such as ripretinib target resistant mutations, positioning QINLOCK favorably. Existing competitors include avapritinib (AYVAKYT) and ripretinib itself, among others in clinical development. The differentiation hinges on efficacy in resistant mutations and tolerability profiles.

2. Regulatory Environment

The accelerated approval pathways associated with orphan indications have expedited QINLOCK's market entry. Post-marketing commitments and continued data collection are critical, especially with potential label expansions, which could extend beyond GIST to other KIT or PDGFRA mutation-driven tumors[4].

3. Pricing and Reimbursement

Pricing strategies are aligned with the orphan drug premium, often reflecting high development costs and the limited patient pool. Reimbursement decisions by payers will significantly influence uptake, particularly in key markets such as the U.S. and Europe. Demonstrable clinical benefits are essential for favorable reimbursement status.

4. Clinical Adoption & Physician Preferences

Physician acceptance hinges on demonstrated superior efficacy and manageable safety profiles. Awareness campaigns and inclusion in clinical guidelines further drive adoption. Real-world evidence (RWE) will bolster credibility and facilitate wider utilization.

5. Market Penetration & Geographic Expansion

Initially focused on North America and Europe, expansion into emerging markets presents significant growth opportunities, albeit countered by challenges such as cost constraints and healthcare infrastructure differences.

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Financial Trajectory

1. Revenue Projections

QINLOCK generated approximately $150 million in global sales in its first year post-approval (2021), with estimates projecting a compound annual growth rate (CAGR) of 20-25% over the next five years[5]. Sales are expected to be driven by increased adoption in second-line settings and potential authorization in first-line treatment, contingent upon ongoing trial results.

2. Cost Structure and Profitability

Initial R&D expenditure encompassed clinical trials, regulatory filings, and manufacturing scale-up, totaling hundreds of millions of dollars. As patent protection stabilizes, profit margins are anticipated to improve, particularly with increased market share and streamlined production costs.

3. Future Investment and Pipeline Development

Companies expect continued investment in expanding QINLOCK’s indications and developing next-generation inhibitors to combat resistance. Such pipeline advancements may sustain long-term revenues beyond current indications.

4. Market Risks Affecting Financial Performance

Key risks include competition from emerging therapies, regulatory setbacks, payer reimbursement barriers, and potential safety concerns. Market-facing strategies will need agility to adapt to evolving healthcare landscapes.

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Strategic Opportunities and Challenges

Opportunities:

• Label Expansion: Demonstrating efficacy in earlier lines of therapy or other KIT/PDGFRA mutation-driven conditions could significantly escalate revenues.
• Combination Therapies: Synergistic regimens incorporating QINLOCK may improve outcomes, opening new treatment paradigms.
• Biomarker-driven Precision Medicine: Tailoring therapy based on mutation profiles enhances clinical efficacy and could command premium pricing.

Challenges:

• Market Penetration in Rarity: Limited patient population constrains overall sales but emphasizes the importance of high-value treatment.
• Competitive Innovation: Rapid advancements in targeted oncology agents could dilute market share.
• Reimbursement and Access Barriers: Cost considerations may delay adoption, especially in publicly funded healthcare systems.

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Conclusion

QINLOCK presents a compelling case study of a targeted therapy navigating a niche yet high-value oncology market. Its financial trajectory promises steady growth fueled by unmet medical need, strategic market positioning, and ongoing clinical validation. Optimal success hinges on expansion into broader indications, strong payer and physician engagement, and vigilant management of competitive pressures.

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Key Takeaways

• Market potential for QINLOCK remains robust within the rare GIST segment, driven by its role in overcoming treatment resistance.
• Strategic expansion into earlier lines and parallel indications could multiply revenues.
• Pricing strategies and reimbursement policies are critical in maximizing market penetration.
• Clinical outcomes and real-world data will shape adoption and influence future regulatory approvals.
• Investment in pipeline development and combination therapies enhances sustainability and competitive edge.

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FAQs

Q1: What is the primary mechanism of action of QINLOCK?
QINLOCK inhibits KIT and PDGFRA kinases, including mutant forms responsible for resistance in GIST, thereby stabilizing disease progression.

Q2: How does QINLOCK differentiate from other TKIs in GIST?
QINLOCK specifically targets resistant mutations, offering an effective option for patients who progress after standard TKIs like imatinib.

Q3: What are the main challenges in the commercial success of QINLOCK?
Challenges include market penetration limited by the rarity of GIST, high drug costs, payer reimbursement hurdles, and competition from emerging agents.

Q4: Are there ongoing clinical trials expanding QINLOCK’s indications?
Yes, trials are investigating QINLOCK in earlier lines of therapy and other tumor types driven by KIT or PDGFRA mutations.

Q5: What is the outlook for QINLOCK’s market share in the coming years?
With increasing adoption, label expansions, and successful pipeline development, QINLOCK’s market share is projected to grow steadily over the next five years.

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References

[1] U.S. Food and Drug Administration. (2020). FDA Approves Ripretinib for Advanced GIST.
[2] Demetri, G. D., et al. (2019). Gastrointestinal stromal tumors: biology and treatment advances. Nature Reviews Clinical Oncology.
[3] Joensuu, H., et al. (2020). Recent advances in gastrointestinal stromal tumor management. Nature Reviews Clinical Oncology.
[4] FDA. (2021). Post-marketing commitments for ripretinib.
[5] EvaluatePharma. (2022). Market Intelligence Report: Oncology Drugs.

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