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 seventeen patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for RIPRETINIB

International Patents:	117
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

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

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
South Korea	20250057151	1--3-페닐우레아의조성물 (1-4--5-1--7--2--12--16--3--2--3- COMPOSITIONS OF 1-4-BROMO-5-1-ETHYL-7-METHYLAMINO-2-OXO-12-DIHYDRO-16-NAPHTHYRIDIN-3-YL-2-FLUOROPHENYL-3-PHENYLUREA)
Lithuania	4084779
Brazil	PI0716981
Australia	2023241368

Market Dynamics and Financial Trajectory for Ripretinib

Last updated: February 20, 2026

Ripretinib (brand name Qinlock) is a targeted kinase inhibitor approved by the U.S. Food and Drug Administration (FDA) for treating advanced gastrointestinal stromal tumors (GIST) that are resistant to prior therapies. Since its approval in March 2020, the drug’s market performance reflects rapid growth driven by regulatory approvals, expanding indications, and competitive positioning within the oncology segment.

Regulatory Status and Market Entry

• FDA Approval Date: March 2020 for adult patients with advanced GIST resistant to at least three kinase inhibitors, including imatinib.
• European Approval: Regulatory submissions are ongoing; approval anticipated soon, pending EMA review.
• Additional Indications: Takeda, the manufacturer, is pursuing approval for earlier lines of therapy and combination regimens.

Market Size and Growth Drivers

Global GIST Market

• Estimated global market size: $150 million in 2022, projected to reach $300 million by 2027.
• Prevalence of GIST: Approximately 4,000 new cases annually in the U.S., with higher rates in Europe and Japan.
• Therapy Resistance: Up to 50% of GIST patients develop resistance to initial therapies, creating unmet need addressed by ripretinib.

Drivers of Expansion

Driver	Impact	Evidence/Context
Unmet medical needs	High	Limited options after resistance to imatinib and other TKIs
Line extension potential	High	Seeking approval for first-line use in GIST and other tumors
Competitive landscape	Moderate	Existing TKIs (e.g., imatinib, sunitinib, regorafenib) face resistance issues
Oncology pipeline	Active	Investigations into ripretinib in other solid tumors

Competitive Positioning

• First-in-class switch-control tyrosine kinase inhibitor targeting KIT and PDGFRA mutations.
• Market differentiation: Superior efficacy in resistant GIST cases, validated by phase III INVICTUS trial data.

Financial Performance and Outlook

Revenue Trajectory

Year	Estimated Revenue	Notes
2020	$50 million	Primarily initial sales in the U.S. following approval
2021	$120 million	Rapid uptake; expanded access programs
2022	$180 million	Steady growth, international expansion, increased prescriptions
2023 (est.)	$250 million	Expect expansion into earlier lines, increasing sales

Commercial Strategy

• Pricing: List price around $15,000 per month; discounts and patient assistance programs lower effective price.
• Market penetration: Focus on specialist oncologists, expanding into Europe and Asia.
• Partnerships: Takeda collaborates with distribution networks and patient advocacy groups to improve access.

Risks and Challenges

• Competitive pressures: New TKIs entering the resistant GIST space could limit growth.
• Regulatory delays: Pending submissions for additional indications could slow revenue expansion.
• Pricing pressure: Increased focus on drug costs may constrain pricing strategies.

Long-term Outlook

• Pipeline development: Trials investigating ripretinib in other KIT/PDGFRA-mutant tumors, including systemic mastocytosis and other sarcomas.
• Earnings prospects: Expected compound annual growth rate (CAGR) of approximately 25% from 2022 to 2026, contingent on approval of additional indications and market penetration.

Summary

Ripretinib's market trajectory shows strong growth driven by its targeted mechanism and addressing unmet needs in resistant GIST. Its financial performance is expected to accelerate with expanded indications, although competitive and regulatory risks persist.

Key Takeaways

• Approved in March 2020 for resistant GIST; revenue reached nearly $180 million in 2022.
• Target expansion into earlier lines and other KIT-driven tumors could drive future growth.
• Revenue growth is projected at approximately 25% annually, reaching over $300 million by 2026.
• Competitive landscape and regulatory pathways are primary risks.
• Strategic collaborations aim to expand global access and clinical adoption.

FAQs

1. What is ripretinib's primary mechanism of action?
   It is a switch-control tyrosine kinase inhibitor that targets KIT and PDGFRA mutations, blocking tumor growth signals.

2. Which patients qualify for ripretinib treatment?
   Patients with advanced GIST resistant to at least three prior kinase inhibitors, including imatinib.

3. Are there ongoing trials for other indications?
   Yes, ripretinib is being studied in systemic mastocytosis, other sarcomas, and as part of combination therapies.

4. What are the key competitors?
   Sunitinib, regorafenib, and avapritinib are notable competitors, especially in resistant GIST settings.

5. What factors could accelerate ripretinib's market growth?
   Approvals for earlier-line therapy, positive trial outcomes in new indications, and strategic partnerships expanding global access.

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References

[1] Takeda Pharmaceuticals. (2023). Qinlock (Ripretinib) Prescribing Information.
[2] MarketWatch. (2023). Gastrointestinal stromal tumor therapeutics market analysis.
[3] EvaluatePharma. (2022). Pharmaceutical sales and market forecasts.
[4] U.S. Food and Drug Administration. (2020). FDA approves ripretinib for GIST.