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 thirty-eight patents protecting this drug.

This drug has one hundred and seven patent family members in twenty-four 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.

Indicators of Generic Entry

Summary for QINLOCK

International Patents:	107
US Patents:	38
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	1
Patent Applications:	51
Drug Prices:	Drug price information 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

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 thirty-eight US patents and two FDA Regulatory Exclusivities.

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
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
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes			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/005614 Qinlock 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
European Patent Office	4013412	RIPRETINIB POUR LE TRAITEMENT DE TUMEURS STROMALES GASTRO-INTESTINALES (RIPRETINIB FOR TREATING GASTROINTESTINAL STROMAL TUMORS)
China	118948773	1-(4溴-5-(1乙基-7-(甲氨基)-2侧氧基-1,2-二氢-1,6-萘啶-3基)-2氟苯基)-3-苯基脲的组合物 (Compositions of 1-(4 bromo-5-(1 ethyl-7-(methylamino)-2-pendant oxy-1, 2-dihydro-1, 6-naphthyridin-3-yl)-2 fluorophenyl)-3-phenylurea)
Japan	5265550
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
European Patent Office	4084779	COMPOSITIONS DE 1-(4-BROMO-5-(1-ÉTHYL-7-(MÉTHYLAMINO)-2-OXO-1,2-DIHYDRO -1,6-NAPHTHYRIDINE-3-YL)-2-FLUOROPHÉNYL)-3-PHÉNYLUREE (COMPOSITIONS OF 1-(4-BROMO-5-(1-ETHYL-7-(METHYLAMINO)-2-OXO-1,2-DIHYDRO-1,6-NAPHTHYRIDIN-3-YL)-2-FLUOROPHENYL)-3-PHENYLUREA)
Argentina	122355	COMPOSICIONES DE 1-(4-BROMO-5-(1-ETIL-7-(METILAMINO)-2-OXO-1,2- DIHIDRO-1,6-NAFTIRIDIN-3-YL)-2-FLUOROFENIL)-3-FENILUREA

Market Dynamics and Financial Trajectory for QINLOCK

Introduction to QINLOCK

QINLOCK, developed by Deciphera Pharmaceuticals, is a tyrosine kinase inhibitor specifically designed to treat gastrointestinal stromal tumor (GIST) and other rare cancers. The drug has shown significant promise and has been a key driver of Deciphera's financial growth.

Revenue Growth and Performance

QINLOCK has demonstrated robust revenue growth over the past few years. In 2023, the drug's net product revenue increased by 27% to $159.1 million compared to 2022, highlighting its strong market performance[3][4].

Quarterly Performance

In the fourth quarter of 2023, QINLOCK generated $46.7 million in net product revenue, with $35.3 million coming from the U.S. and $11.4 million from international markets. This represents a 42% increase from the fourth quarter of 2022[3][4].

Annual Revenue

For the full year 2023, QINLOCK's net product revenue reached a record high, contributing significantly to Deciphera's total revenue of $163.4 million[3][4].

Market Expansion and Geographic Reach

Deciphera has been actively expanding QINLOCK's market presence globally.

U.S. Market

In the U.S., QINLOCK has seen consistent growth, with a 25% increase in net product revenue over 2022[1].

International Markets

Internationally, QINLOCK has also performed well, with successful launches in countries like Italy and a partnership with GENESIS for Central and Eastern Europe[1].

Clinical Studies and Regulatory Milestones

The success of QINLOCK is supported by positive clinical study results and ongoing regulatory efforts.

INTRIGUE Phase 3 Study

The INTRIGUE Phase 3 study published in Nature Medicine demonstrated substantial clinical benefits of QINLOCK in second-line GIST patients with mutations in KIT exon 11 and 17/18[4].

INSIGHT Phase 3 Study

Deciphera is continuing enrollment in the INSIGHT Phase 3 study, which compares QINLOCK to sunitinib in second-line GIST patients with specific KIT mutations[4].

Financial Stability and Cash Position

Deciphera's strong financial position is crucial for the continued development and marketing of QINLOCK.

Cash Reserves

As of the end of 2023, Deciphera had a cash position of $352 million, which is expected to fund operations into the second half of 2026[1][3].

Operating Expenses

Research and development expenses for Q4 2023 were $58.6 million, and selling, general, and administrative expenses were $39.1 million. Despite these costs, the company's cash reserves and revenue growth indicate a stable financial outlook[1].

Label Expansion and Future Prospects

Deciphera is actively pursuing label expansion opportunities for QINLOCK to further increase its market potential.

Ongoing Studies and Submissions

The company is preparing for potential regulatory submissions, including the ongoing INSIGHT Phase 3 study and the planned submission of a New Drug Application (NDA) for Vimseltinib, another promising drug, in the second quarter of 2024[1][3].

Peak Revenue Projections

Deciphera expects QINLOCK and Vimseltinib to reach over $1 billion in peak global revenue, indicating a significant growth trajectory for these drugs[1].

Challenges and Risks

Despite the positive outlook, there are challenges to consider.

Reimbursement Processes

Predicting new market openings can be challenging due to varying reimbursement processes and timelines, which may affect revenue growth[1].

Quarter-over-Quarter Variability

There is potential quarter-over-quarter variability in revenue growth, which could impact short-term financial performance[1].

Analyst and Market Sentiment

Analysts and market observers are generally optimistic about Deciphera's prospects.

Analyst Optimism

Four analysts have revised their earnings upwards for the upcoming period, reflecting a positive outlook for Deciphera's financial performance[1].

Market Perception

The strong revenue growth and positive clinical study results have positioned Deciphera as a strong buy, particularly due to QINLOCK's impressive sales and the promising prospects of Vimseltinib[5].

Key Takeaways

• QINLOCK has achieved record annual revenue, driven by strong growth in both the U.S. and international markets.
• Deciphera has a solid cash position, extending its cash runway into the second half of 2026.
• The company is actively pursuing label expansion opportunities and regulatory submissions for QINLOCK and Vimseltinib.
• Positive clinical study results, such as those from the INTRIGUE Phase 3 study, support QINLOCK's market position.
• Despite challenges, the overall financial trajectory and market dynamics indicate a strong future for QINLOCK.

FAQs

What is QINLOCK used for?

QINLOCK is used to treat gastrointestinal stromal tumor (GIST) and other rare cancers.

How has QINLOCK performed financially in 2023?

QINLOCK's net product revenue increased by 27% to $159.1 million in 2023 compared to 2022.

What are the peak revenue projections for QINLOCK and Vimseltinib?

Deciphera expects QINLOCK and Vimseltinib to reach over $1 billion in peak global revenue.

What are the key challenges facing QINLOCK's market expansion?

Challenges include predicting new market openings due to varying reimbursement processes and potential quarter-over-quarter variability in revenue growth.

What is the current cash position of Deciphera Pharmaceuticals?

As of the end of 2023, Deciphera had a cash position of $352 million, expected to fund operations into the second half of 2026.

Sources:

1. Investing.com - "Earnings call: Deciphera reports strong QINLOCK growth, eyes $1 B peak revenue"
2. Business Wire - "Deciphera Pharmaceuticals Announces Second Quarter 2023 Financial Results"
3. Stock Titan - "Deciphera Pharmaceuticals Announces Fourth Quarter and Full Year 2023 Financial Results"
4. BioSpace - "Deciphera Pharmaceuticals Announces Fourth Quarter and Full Year 2023 Financial Results"
5. Business Insider - "Deciphera Pharmaceuticals: A Strong Buy on Impressive Qinlock Sales and Promising Vimseltinib Prospects"

Last updated: 2024-12-16