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 twenty-three 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:	123
US Patents:	41
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QINLOCK

US Patents and Regulatory Information for QINLOCK

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

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			Y
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes			Y	Y
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes			Y
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes			Y	Y
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes			Y
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes

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

New Zealand

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
European Patent Office	4327827
Japan	2010503701
Finland	4084778
European Patent Office	4013335	SYSTÈME D'ORIENTATION RACHIDIEN (SPINAL ORIENTATION SYSTEM)
Finland	4013412
New Zealand	784949	Ripretinib for treating gastrointestinal stromal tumors

Investment Scenario and Fundamentals Analysis for QINLOCK (Ripretinib)

Last updated: February 20, 2026

What is QINLOCK?

QINLOCK (ripretinib) is a kinase inhibitor marketed by Deciphera Pharmaceuticals. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced gastrointestinal stromal tumors (GIST) following prior treatment with three or more kinase inhibitors. The drug targets KIT and PDGFRA mutations, which drive GIST progression.

Market Landscape

GIST Treatment Market Overview

• Estimated global GIST market size in 2022: approximately USD 600 million.
• Expected compound annual growth rate (CAGR): 8-10% through 2030, driven by increased diagnosis and drug approvals.
• Main competitors:
  • Imatinib (first-line)
  • Sunitinib
  • Regorafenib
  • Avapritinib (AYVYRTI)
  • Ripretinib (QINLOCK)

QINLOCK’s Market Position

• Approved for use after failure of three prior therapies.
• Monotherapy indication for adult patients with advanced GIST.
• Sales in 2022: USD 150 million.
• Sales expected to grow as approval expands to earlier lines and off-label use increases.

Clinical and Regulatory Fundamentals

Clinical Trial Data

• Pivotal trial: INVICTUS (NCT03203131)
  • Enrolled 129 patients with advanced GIST post-third-line therapy.
  • Median progression-free survival (PFS): 6.3 months versus 1.0 month with placebo.
  • Response rate: 9.4%; disease control rate: 91.6%.

Regulatory Status

• FDA approval: May 2020.
• EMA approval: July 2021.
• Additional approvals under review or in early markets.

Financial and Investment Fundamentals

Revenue Drivers

• Current sales: USD 150 million (2022).
• Growth catalysts:
  • Label expansion to second-line therapy.
  • Increased awareness among oncologists.
  • Entry into Asian markets, especially Japan.

Cost Structure

• R&D: Approximately 25% of revenues annually.
• Manufacturing: Marginal cost of production fraction, constrained by sourcing of target-specific kinase inhibitors.
• Marketing and sales: Consists primarily of direct sales teams and healthcare provider outreach.

Profitability

• Deciphera has reported net losses aligned with R&D investments.
• Break-even projected in 2024 contingent on sales growth and cost management.

Patent and Intellectual Property

• Composition of matter patent granted until at least 2030.
• Data exclusivity until 2025 in the U.S., potential extension through orphan designation or pediatric exclusivity.

Competitive and Regulatory Risks

Risk Category	Details
Patent Litigation	Potential patent challenges post-2030.
Regulatory Delays	Approval of label expansions depends on clinical data.
Market Penetration	Competition from other advanced GIST therapies.
Off-label Use and Pricing	Price pressure from payers, insurance, and formulary decisions.

Investment Outlook

Strengths

• Approved for a significant unmet need, with high unmet medical demand post-third-line therapy.
• Clear efficacy profile from pivotal trials.
• Growing sales pipeline and geographic expansion opportunities.

Challenges

• Heavy dependence on GIST market dynamics.
• Competitive landscape with newer targeted therapies.
• Patent expiration risk in mid-2020s.

Valuation Considerations

• Discounted cash flow (DCF) models: assume sales growth of 15% annually over the next five years, with gross margins above 60%.
• Peer comparison: Ribociclib (Novartis) and other kinase inhibitors valued at 8-12x forward revenues.
• Market cap as of December 2022: approximately USD 4 billion.

Key Takeaways

• QINLOCK is a targeted therapy with regulatory approval primarily in post-third-line GIST.
• Peak sales potential remains contingent on label expansion and geographic penetration.
• The company's future profitability depends on successful commercialization, patent protections, and navigating competitive pressures.
• Investment risk remains high with a need to monitor regulatory, patent, and market entry developments.

FAQs

1. What are QINLOCK’s primary indications?
QINLOCK is approved for adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors.

2. How does QINLOCK’s efficacy compare with other GIST treatments?
It extends median PFS to 6.3 months in late-line settings, offering a meaningful benefit over placebo, but its response rate remains modest. Efficacy in earlier lines is under clinical evaluation.

3. What are the main risks for investors?
Patent expiration around 2030, competitive threats from emerging therapies, regulatory delays in label expansion, and pricing pressures.

4. Are there expansion opportunities for QINLOCK?
Yes, in second-line settings and other treatment lines pending positive trial data, along with geographic expansion into markets like Japan.

5. How do Deciphera’s R&D expenses impact financial forecasts?
High R&D spending (~25% of revenue) constrains near-term profitability but supports pipeline development and potential future revenue growth.

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References
[1] Deciphera Pharmaceuticals. (2022). QINLOCK (ripretinib) prescribing information.
[2] GlobalData. (2022). GIST market analysis report.
[3] FDA. (2020). QINLOCK (ripretinib) approval announcement.
[4] ClinicalTrials.gov. (2023). INVICTUS trial details.