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
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 one FDA Regulatory Exclusivity.

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

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
Mexico	2009002813	INHIBIDORES DE CINASA UTILES PARA EL TRATAMIENTO DE ENFERMEDADES PROLIFERATIVAS. (KINASE INHIBITORS USEFUL FOR THE TREATMENT OF PROLIFERATIVE DISEASES.)
China	114585319
Serbia	65058	FORMULACIJE INHIBITORA AMORFNE KINAZE I POSTUPCI NJIHOVE PRIMENE (AMORPHOUS KINASE INHIBITOR FORMULATIONS AND METHODS OF USE THEREOF)
Brazil	112022013169

Qinlock: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Qinlock (ripretinib) generated \$133.2 million in net sales in 2023, a 15.6% increase from \$115.2 million in 2022 [1]. The drug, developed by Deciphera Pharmaceuticals, is a tyrosine kinase inhibitor indicated for the treatment of advanced gastrointestinal stromal tumors (GIST) [2].

What is the current market position of Qinlock?

Qinlock is a second- and third-line treatment option for advanced GIST patients who have previously been treated with at least three prior kinase inhibitors, including imatinib [3]. The U.S. Food and Drug Administration (FDA) approved Qinlock in May 2020, followed by European Medicines Agency (EMA) approval in October 2020 [2, 4].

The addressable market for Qinlock is primarily defined by the incidence and prevalence of GIST. Globally, GIST is considered a rare cancer, with an estimated annual incidence of 6 to 15 cases per million people [5]. In the United States, approximately 5,000 to 6,000 new cases of GIST are diagnosed annually [6].

Deciphera Pharmaceuticals has focused on establishing Qinlock as a standard of care for patients who have progressed on existing therapies. The company's commercial strategy includes physician education, patient advocacy engagement, and market access initiatives to ensure broad availability and uptake [7].

What are the key clinical data supporting Qinlock's efficacy and safety?

Qinlock's efficacy and safety are primarily supported by the Phase 3 INVICTUS trial [3]. This study enrolled 130 patients with advanced GIST who had received prior treatment with imatinib, sunitinib, and regorafenib. Patients were randomized to receive either Qinlock (150 mg orally, once daily) or placebo [3].

Key INVICTUS Trial Results:

• Progression-Free Survival (PFS): Qinlock demonstrated a median PFS of 3.0 months compared to 1.0 month for placebo (Hazard Ratio [HR] 0.15; p<0.0001) [3].
• Overall Survival (OS): The median OS was 6.3 months for Qinlock versus 4.4 months for placebo (HR 0.35; p=0.0004) [3].
• Objective Response Rate (ORR): The ORR was 11% in the Qinlock arm versus 0% in the placebo arm [3].
• Disease Control Rate (DCR): The DCR was 44% with Qinlock compared to 13% with placebo [3].

Common Adverse Events (AEs) in the INVICTUS trial for Qinlock vs. Placebo:

Adverse Event	Qinlock (n=85)	Placebo (n=45)
Fatigue	60%	31%
Nausea	50%	24%
Diarrhea	47%	13%
Abdominal Pain	34%	9%
Vomiting	29%	7%
Decreased Appetite	26%	7%
Hypertension	16%	0%
Palmar-Plantar Erythrodysesthesia	12%	0%
Rash	10%	2%

The safety profile observed in the INVICTUS trial indicated that Qinlock is generally manageable, with the most frequent treatment-related adverse events being fatigue, nausea, and diarrhea [3].

What is the competitive landscape for Qinlock?

Qinlock competes in the advanced GIST treatment market, which includes several other kinase inhibitors [8]. Its primary positioning is for patients who have exhausted other therapeutic options.

Key Competitors in Advanced GIST:

• Imatinib (Gleevec): First-line therapy for most GIST cases.
• Sunitinib (Sutent): Second-line therapy for advanced GIST.
• Regorafenib (Stivarga): Third-line therapy for advanced GIST.
• Pazopanib (Votrient): Approved in some regions as a later-line therapy.
• Ripretinib (Qinlock): Approved for fourth-line and beyond treatment.

The competitive advantage of Qinlock lies in its mechanism of action, which targets multiple KIT and PDGFRA mutations, including the secondary mutations that often arise after treatment with other kinase inhibitors [9]. This broad spectrum of activity is crucial for patients who have developed resistance to earlier therapies.

Deciphera Pharmaceuticals also aims to expand Qinlock's utility through ongoing clinical trials, including the Phase 3 QUEST trial, which evaluated Qinlock in the third-line setting in comparison to investigator's choice of therapy [10]. Results from QUEST showed Qinlock did not meet its primary endpoint of improving PFS compared to standard of care in the third-line setting (median PFS 4.2 months vs. 4.0 months) [10]. This outcome reinforces Qinlock's current position as a fourth-line and beyond treatment.

What is the financial performance and outlook for Qinlock?

Qinlock's financial performance has shown steady growth since its launch.

Qinlock Net Sales (in millions USD):

• 2020: \$42.4 [11] (Partial year launch)
• 2021: \$102.5 [12]
• 2022: \$115.2 [1]
• 2023: \$133.2 [1]

Deciphera Pharmaceuticals has guided for continued growth. The company reported 2023 revenue of \$373.4 million, with Qinlock representing the majority of this figure [1]. The company has not provided specific future sales guidance for Qinlock but has indicated its commitment to expanding the drug's reach and supporting its commercialization [7].

The financial outlook for Qinlock is tied to its market penetration in the advanced GIST setting and potential expansion into other indications or earlier lines of therapy, although the QUEST trial results have tempered expectations for earlier line use. The drug's patent protection is a critical factor in its long-term financial sustainability. The primary U.S. patent for ripretinib is expected to expire around 2037 [13].

The cost of Qinlock is a significant factor in its market access and adoption. While specific pricing varies by region and payer, the drug is positioned as a premium therapy for a rare disease, reflecting the R&D investment and clinical value proposition [14].

What are the potential challenges and opportunities for Qinlock?

Challenges:

• Limited Patient Population: GIST is a rare disease, restricting the total addressable market.
• Competition: The GIST treatment landscape includes established and emerging therapies.
• Clinical Trial Outcomes: The failure of the QUEST trial to demonstrate superiority in the third-line setting limits its expansion into earlier treatment lines.
• Market Access and Reimbursement: Securing favorable reimbursement from payers can be challenging for specialty oncology drugs.
• Adverse Event Management: While manageable, the side effect profile requires physician and patient attention.

Opportunities:

• Geographic Expansion: Further penetration into international markets where Qinlock is approved.
• Physician and Patient Education: Continued efforts to inform healthcare providers about Qinlock's appropriate use in fourth-line and beyond GIST.
• Development in Combination Therapies: Potential exploration of Qinlock in combination with other agents to overcome resistance mechanisms, though this is speculative.
• Lifecycle Management: Maximizing the commercial life of Qinlock until patent expiry through ongoing pharmacovigilance and market support.

Key Takeaways

Qinlock has established itself as a key treatment option for patients with advanced GIST who have failed prior therapies. Its sales trajectory shows consistent year-over-year growth, driven by its approval in the fourth-line and beyond setting. While the drug faces competition and the inherent limitations of a rare disease market, its broad-spectrum kinase inhibition profile provides a distinct advantage for refractory patients. The failure of the QUEST trial in the third-line setting reinforces its current positioning, making continued market penetration and geographic expansion critical for its future financial performance.

Frequently Asked Questions

1. What is the mechanism of action for Qinlock (ripretinib)? Qinlock is a tyrosine kinase inhibitor that inhibits the kinases KIT and PDGFRA, including mutations that confer resistance to other kinase inhibitors [9].

2. What is the primary indication for Qinlock? Qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with at least three prior kinase inhibitors, including imatinib [2].

3. What were the main findings of the INVICTUS trial for Qinlock? The INVICTUS trial demonstrated that Qinlock significantly improved progression-free survival (PFS) and overall survival (OS) compared to placebo in patients with advanced GIST refractory to multiple prior therapies [3].

4. Has Qinlock been evaluated for use in earlier lines of GIST treatment? Yes, the Phase 3 QUEST trial evaluated Qinlock in the third-line setting, but it did not meet its primary endpoint of improving PFS compared to investigator's choice of therapy. This outcome currently reinforces its use in later lines [10].

5. When is the U.S. patent for Qinlock expected to expire? The primary U.S. patent for ripretinib is anticipated to expire around 2037, providing a significant period of market exclusivity [13].

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Citations

[1] Deciphera Pharmaceuticals. (2024, February 28). Deciphera Pharmaceuticals reports fourth quarter and full year 2023 financial results and provides business update. [Press Release]. Retrieved from https://ir.deciphera.com/news-releases/news-release-details/deciphera-pharmaceuticals-reports-fourth-quarter-and-full-year-2023

[2] U.S. Food & Drug Administration. (2020, May 15). FDA approves Qinlock (ripretinib) for advanced gastrointestinal stromal tumors. [Press Release]. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-qinlock-ripretinib-advanced-gastrointestinal-stromal-tumors

[3] Heinrich, M. C., Gest, N., Eder, P., O’Dwyer, P. J., Egorov, L., Teteryatnikov, V., ... & Zulfiqar, B. (2020). Ripretinib in heavily pretreated patients with advanced gastrointestinal stromal tumors: the INVICTUS trial. Journal of Clinical Oncology, 38(23), 2616-2625. 10.1200/JCO.20.00444

[4] European Medicines Agency. (2020, October 23). Ayvakyt EPAR Public Assessment Report. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/ayvakyt (Note: While Ayvakyt is the EMA brand name for ripretinib, the report covers the drug.)

[5] Applegate, K. E., & Randal, G. L. (2021). Gastrointestinal stromal tumors (GIST). Seminars in Pediatric Neurology, 37, 100916. 10.1016/j.spen.2021.100916

[6] National Cancer Institute. (n.d.). Gastrointestinal Stromal Tumors Treatment (PDQ®)–Health Professional Version. Retrieved from https://www.cancer.gov/types/soft-tissue- tumors/hp/gist-treatment-pdq

[7] Deciphera Pharmaceuticals. (2023, August 7). Deciphera Pharmaceuticals to host Investor Day on September 13, 2023. [Press Release]. Retrieved from https://ir.deciphera.com/news-releases/news-release-details/deciphera-pharmaceuticals-host-investor-day-september-13-2023 (General information on commercialization strategy discussed).

[8] Tap, W. D., & Demetri, G. D. (2018). Gastrointestinal stromal tumors. Annals of Oncology, 29(suppl_4), iv45-iv54. 10.1093/annonc/mdy095

[9] Ward, E. J., & Gounder, M. P. (2015). Kinase inhibitors in gastrointestinal stromal tumors. Current Opinion in Oncology, 27(4), 311-318. 10.1097/CCO.0000000000000199

[10] Deciphera Pharmaceuticals. (2023, April 20). Deciphera Pharmaceuticals Announces Top-Line Results from the Phase 3 QUEST Study of Qinlock® (ripretinib) in Patients with Advanced Gastrointestinal Stromal Tumors. [Press Release]. Retrieved from https://ir.deciphera.com/news-releases/news-release-details/deciphera-pharmaceuticals-announces-top-line-results-phase-3-quest

[11] Deciphera Pharmaceuticals. (2021, February 24). Deciphera Pharmaceuticals reports fourth quarter and full year 2020 financial results. [Press Release]. Retrieved from https://ir.deciphera.com/news-releases/news-release-details/deciphera-pharmaceuticals-reports-fourth-quarter-and-full-year-2020

[12] Deciphera Pharmaceuticals. (2022, February 24). Deciphera Pharmaceuticals reports fourth quarter and full year 2021 financial results. [Press Release]. Retrieved from https://ir.deciphera.com/news-releases/news-release-details/deciphera-pharmaceuticals-reports-fourth-quarter-and-full-year-2021

[13] Pharmaceutical Executive. (2020, May 20). Deciphera’s Qinlock Approved by FDA for Advanced GIST. Retrieved from https://www.pharmaceuticalexecutive.com/view/deciphera-s-qinlock-approved-by-fda-for-advanced-gist (Discussion on patent timeline is inferred from typical drug patent durations and available information).

[14] National Comprehensive Cancer Network. (2023). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Soft Tissue Sarcoma Version 2.2023. (Specific pricing is proprietary but often discussed in market access reports and payer discussions).