Ripretinib - Generic Drug Details

What are the generic drug sources for ripretinib and what is the scope of freedom to operate?

Ripretinib is the generic ingredient in one branded drug marketed by Deciphera Pharms and is included in one NDA. There are thirty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ripretinib has eighty-seven patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for ripretinib

International Patents:	87
US Patents:	35
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	12
Patent Applications:	112
What excipients (inactive ingredients) are in ripretinib?	ripretinib excipients list
DailyMed Link:	ripretinib at DailyMed

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

Constraining patent/regulatory exclusivity:

11,185,535

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
Pfizer	Phase 1/Phase 2
Asan Medical Center	Phase 2
Theseus Pharmaceuticals	Phase 1/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	12,023,325
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes	11,344,536
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes	RE48731
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes	11,793,795		Y
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes	11,266,635

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/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 ripretinib

Country	Patent Number	Title	Estimated Expiration
Brazil	112022002609	MÉTODOS DE TRATAMENTO DE TUMORES ESTROMAIS GASTROINTESTINAIS
Mexico	2009002814	INHIBIDORES DE CINASA UTILES PARA EL TRATAMIENTO DE ENFERMEDADES PROLIFERATIVAS. (KINASE INHIBITORS USEFUL FOR THE TREATMENT OF PROLIFERATIVE DISEASES.)
European Patent Office	4022617	EFFACEMENT DE MÉMOIRE (ERASING MEMORY)
World Intellectual Property Organization (WIPO)	2008033999
Brazil	PI0716844	INIDORES DE QUINASE ÚTEIS PARA O TRATAMENTO DE DOENÇAS PROLIFERATIVAS

Ripretinib Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ripretinib (Qinlock)

Introduction

Ripretinib, marketed as Qinlock, is a broad-spectrum KIT and PDGFRA switch-control tyrosine kinase inhibitor (TKI) approved for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with imatinib, sunitinib, and regorafenib. Here, we delve into the market dynamics and financial trajectory of this drug.

Clinical Efficacy and Market Need

Ripretinib has demonstrated significant clinical efficacy in the fourth-line treatment of advanced GIST. The global phase III INVICTUS study showed a statistically significant improvement in progression-free survival (PFS) and overall survival (OS) compared to placebo[3][4].

Unmet Need

There is a clear unmet need for effective treatments in the fourth-line setting for GIST, as patients often experience disease progression after multiple lines of therapy. Ripretinib addresses this need by delaying disease progression and potentially extending patient survival, while offering an acceptable safety profile and a convenient oral administration[4].

Market Share and Adoption

Clinical experts predict that ripretinib will become a standard of care in the fourth-line setting, with an estimated market share of 90% by year two. This high market share is driven by the lack of other viable treatment options and the clinical benefits observed in the INVICTUS trial[1].

Cost and Cost-Effectiveness

Treatment Costs

The cost of ripretinib is substantial, with an estimated cost of approximately $18,171 per patient per 28 days. This high cost is a significant factor in the drug's cost-effectiveness analysis[4].

Incremental Cost-Effectiveness Ratio (ICER)

The incremental cost-effectiveness ratio (ICER) for ripretinib compared to best supportive care (BSC) is $242,365 per quality-adjusted life-year (QALY). At this ICER, ripretinib is not considered cost-effective at a willingness-to-pay (WTP) threshold of $50,000 per QALY. A price reduction of at least 83% would be necessary for ripretinib to be considered cost-effective at this threshold[1][4].

Limitations in Cost-Effectiveness Analysis

The cost-effectiveness analysis is subject to several limitations, including the overestimation of overall survival (OS) in the sponsor's model, inappropriate characterization of treatment beyond progression, and the lack of face validity in utilities. These limitations introduce significant uncertainty into the cost-effectiveness estimates[1].

Financial Performance of Deciphera Pharmaceuticals

Deciphera Pharmaceuticals, the company behind Qinlock, has seen significant revenue growth from the drug's sales. In the first half of 2021, product revenues from Qinlock were $42.01 million, up from $4.83 million in the same period in 2020[2].

Operating Expenses and Net Loss

Despite the revenue growth, Deciphera Pharmaceuticals incurred substantial operating expenses, including research and development costs of $115.67 million and selling, general, and administrative expenses of $63.58 million for the first half of 2021. This resulted in a net loss of $131.73 million for the same period[2].

Capital Requirements

The commercialization and further development of Qinlock, as well as other drug candidates, require significant additional capital. The company must invest in commercial capabilities, infrastructure, and compliance-reporting capabilities, which adds to the financial burden[2].

Market Impact and Patient Outcomes

Patient Benefits

Ripretinib has been associated with improved health-related quality of life (HRQoL) for patients with advanced GIST. More than half of the patients reported improved HRQoL compared to prior TKIs, and the drug has been well-tolerated with minimal adverse events[4].

Real-World Evidence

A case report highlighted that a patient receiving ripretinib for over a year experienced a progressive reduction in tumor size without any adverse drug reactions, demonstrating the drug's efficacy in real-world settings[5].

Regulatory Approval and Access

Ripretinib has been approved by Health Canada for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib. The approval was based on the INVICTUS trial, which showed significant clinical benefits[4].

Future Perspectives and Challenges

Combination Therapy

There is ongoing research into the use of ripretinib in combination with other TKIs as a late-line treatment for GIST. This approach may offer new hope for patients with refractory GIST by addressing intra- and inter-tumor mutational heterogeneity[3].

Mechanism of Resistance

The mechanism of tumor resistance to ripretinib is currently unknown, which poses a challenge for long-term treatment efficacy. Further research is needed to understand and overcome this resistance[3].

Financial Sustainability

The high cost of ripretinib and the need for significant price reductions to achieve cost-effectiveness pose financial sustainability challenges. The company must balance the need for revenue with the necessity of making the drug accessible to patients[1][4].

Key Takeaways

• Ripretinib has demonstrated significant clinical efficacy in the fourth-line treatment of advanced GIST.
• The drug is expected to capture a high market share due to its clinical benefits and the lack of other viable options.
• The cost-effectiveness analysis is subject to several limitations, making the ICER highly uncertain.
• Deciphera Pharmaceuticals faces significant financial challenges despite revenue growth from Qinlock sales.
• Ripretinib improves HRQoL and is well-tolerated, but its long-term efficacy is challenged by tumor resistance.

FAQs

What is ripretinib used for?

Ripretinib is used for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with imatinib, sunitinib, and regorafenib.

How effective is ripretinib in treating GIST?

Ripretinib has shown significant clinical efficacy in delaying disease progression and improving overall survival compared to placebo in the fourth-line setting for GIST.

What are the main limitations in the cost-effectiveness analysis of ripretinib?

The main limitations include the overestimation of overall survival, inappropriate characterization of treatment beyond progression, and the lack of face validity in utilities.

How much does ripretinib cost?

The treatment with ripretinib costs approximately $18,171 per patient per 28 days.

Is ripretinib cost-effective at current prices?

No, ripretinib is not considered cost-effective at a willingness-to-pay threshold of $50,000 per QALY. A price reduction of at least 83% would be necessary for it to be considered cost-effective.

Sources

1. Pharmacoeconomic Review - Ripretinib (Qinlock) - NCBI Bookshelf
2. DECIPHERA PHARMACEUTICALS, INC. - Consolidated Financial Statements
3. Ripretinib in combination with tyrosine kinase inhibitor as a late-line treatment - Frontiers in Pharmacology
4. Ripretinib (Qinlock) - NCBI Bookshelf
5. Ripretinib for the treatment of metastatic gastrointestinal stromal tumors - AME Groups