AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE - Generic Drug Details

What are the generic sources for avutometinib potassium; defactinib hydrochloride and what is the scope of freedom to operate?

Avutometinib potassium; defactinib hydrochloride is the generic ingredient in one branded drug marketed by Verastem Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Avutometinib potassium; defactinib hydrochloride has one hundred and twenty-five patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE

International Patents:	125
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

CAPSULE, 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.

US Patents and Regulatory Information for AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Verastem Inc	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)	avutometinib potassium; defactinib hydrochloride	CAPSULE, TABLET;ORAL	219616-001	May 8, 2025		RX	Yes	Yes	7,897,792		Y	Y
Verastem Inc	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)	avutometinib potassium; defactinib hydrochloride	CAPSULE, TABLET;ORAL	219616-001	May 8, 2025		RX	Yes	Yes	11,400,090
Verastem Inc	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)	avutometinib potassium; defactinib hydrochloride	CAPSULE, TABLET;ORAL	219616-001	May 8, 2025		RX	Yes	Yes	11,517,573

International Patents for AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Norway	20083542
Spain	2395840
Norway	341421

AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE Market Analysis and Financial Projection

Last updated: February 17, 2026

What Are the Market Dynamics for Avutometinib Potassium and Defactinib Hydrochloride?

The market landscape for celoratinib and defactinib focuses on their development stages, intended indications, competitive positioning, and regulatory environment. Both drugs are targeted therapies in oncology, with distinct mechanisms. Their commercial success depends on clinical trial outcomes, approval timelines, and market demand for therapies addressing unmet needs.

Clinical Development and Regulatory Status

• Avutometinib potassium (also known as BGB324 or Rucaparib) has progressed through early-phase trials for cancers like non-small cell lung cancer (NSCLC) and ovarian cancer. However, it remains in investigational stages depending on regions and indications.
• Defactinib hydrochloride has advanced to phases II and III for mesothelioma, ovarian cancer, and other malignancies with focal attention on tumors with high FAK (focal adhesion kinase) expression. It has received Orphan Drug Designation for mesothelioma in the U.S.

Market Drivers

• Growing incidence of solid tumors, such as ovarian and mesothelioma, increases the need for targeted therapies.
• The expanding pipeline with positive clinical trial results bolsters investor confidence.
• Regulatory incentives, including orphan drug designations, accelerate development timelines.

Competitive Landscape

• Several tyrosine kinase inhibitors (TKIs) and focal adhesion kinase inhibitors occupy the pipeline space, with drugs like defactinib facing competition from projects like GSK-2256098.
• The success of existing therapies in specific indications limits market penetration for investigational drugs until approvals are secured.

Market Entry Barriers

• High cost of clinical trials prolongs the pathway to commercialization.
• Uncertain efficacy outcomes from late-stage trials impact potential sales.
• Regulatory approval depends on demonstrating safety and efficacy, which is variable across indications.

What Is the Financial Trajectory for These Drugs?

Financial trajectories for such drugs depend on clinical success, patent life, manufacturing costs, and market size.

Revenue Projections

Parameter	Details	Impact
Industry Size	Oncology drugs global market projected to reach USD 290 billion by 2028	Large potential market
Therapeutic Area	Focus on ovarian cancer and mesothelioma; niche markets with high unmet needs	Premium pricing potential
Competitive Edge	Significance of early clinical data influences market share	Early positive data can triple projected sales

Cost of Development and Investment

• Preclinical and clinical trial costs for targeted therapies average from USD 1.0 to 2.0 billion.
• Licensing agreements, partnerships, and strategic alliances can offset R&D costs.
• For drugs still in early phases, revenue projections are speculative; approval prospects are uncertain.

Investment and Licensing Trends

• Venture funding for oncology-targeted therapies reached USD 1.2 billion in 2022.
• Licensing deals, such as Pfizer’s licensing of defactinib from Verastem, have values exceeding USD 100 million upfront, with milestone payments.

Market Penetration Scenarios

• Successful approval in key indications could generate peak sales of USD 500 million to USD 1 billion per drug annually.
• Market exclusivity of 10 to 12 years effectively extends revenue streams.

How Do These Drugs Fit Within Broader Market Trends?

• Increase in precision medicine adoption supports targeted kinase inhibitors.
• Regulatory pathways favor orphan drugs with expedited review processes.
• Enabling technologies like companion diagnostics improve tailored treatment access.

Implications for Investors and R&D

• Drugs with promising early-phase data position for accelerated approval.
• Companies with strategic partnerships can share risk and optimize resource deployment.
• A shift toward combination therapies may impact long-term revenue forecasts.

Key Takeaways

• Avutometinib potassium and defactinib hydrochloride are in the development pipeline with targeted oncology applications.
• Market success hinges on clinical trial outcomes, regulatory approvals, and competitive dynamics.
• The oncology market’s size and unmet needs support premium pricing if drugs prove efficacious.
• Development costs are substantial, but strategic alliances and regulatory incentives mitigate some risks.
• Post-approval, peak sales estimates range from hundreds of millions to over a billion dollars annually, contingent on approved indications and market penetration.

FAQs

1. What are the main indications for avutometinib potassium and defactinib hydrochloride?
Avutometinib is primarily investigated for NSCLC and ovarian cancers; defactinib for mesothelioma, ovarian, and other solid tumors.

2. How does the regulatory environment affect the prospects for these drugs?
Orphan drug designations and expedited review pathways facilitate earlier market entry but require solid clinical evidence.

3. What variables influence the revenue potential of these therapies?
Clinical trial success, approval timing, market size, pricing strategies, and competitive landscape.

4. How do development costs impact the financial outlook?
High costs demand strategic partnerships; failure at any trial phase can delay or eliminate revenue prospects.

5. What are the key risks to market entry for these drugs?
Efficacy concerns, regulatory rejection, market competition, and pricing pressures.

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Citations
[1] EvaluatePharma. "Oncology Market Forecast 2022."
[2] FDA. "Drug Approvals and Regulatory Incentives."
[3] GlobalData. "Targeted Cancer Therapies Market Analysis."
[4] Verastem. "Defactinib Development and Licensing Announcements."
[5] MarketWatch. "Venture Capital Trends in Oncology."