Mirdametinib - Generic Drug Details

What are the generic drug sources for mirdametinib and what is the scope of patent protection?

Mirdametinib is the generic ingredient in one branded drug marketed by Springworks and is included in two NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mirdametinib has forty-six patent family members in eleven countries.

One supplier is listed for this compound.

Summary for mirdametinib

International Patents:	46
US Patents:	22
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	16
Patent Applications:	1,823
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for mirdametinib
What excipients (inactive ingredients) are in mirdametinib?	mirdametinib excipients list
DailyMed Link:	mirdametinib at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION

Dosage:

TABLET, FOR SUSPENSION;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 mirdametinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
St. Justine's Hospital	PHASE1
National Cancer Institute (NCI)	PHASE2
National Cancer Institute (NCI)	PHASE1

See all mirdametinib clinical trials

Pharmacology for mirdametinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Mitogen-Activated Protein Kinase Kinase 1 Inhibitors Mitogen-Activated Protein Kinase Kinase 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for mirdametinib

L01EE	Mitogen-activated protein kinase (MEK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for mirdametinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Springworks	GOMEKLI	mirdametinib	TABLET, FOR SUSPENSION;ORAL	219379-001	Feb 11, 2025		RX	Yes	Yes
Springworks	GOMEKLI	mirdametinib	TABLET, FOR SUSPENSION;ORAL	219379-001	Feb 11, 2025		RX	Yes	Yes				Y
Springworks	GOMEKLI	mirdametinib	CAPSULE;ORAL	219389-001	Feb 11, 2025		RX	Yes	No
Springworks	GOMEKLI	mirdametinib	TABLET, FOR SUSPENSION;ORAL	219379-001	Feb 11, 2025		RX	Yes	Yes

International Patents for mirdametinib

Country	Patent Number	Title	Estimated Expiration
Japan	2025509659
Colombia	2024012872
Colombia	2024012870	Tratamiento de neurofibromas cutáneos con mirdametinib
Peru	20242178	DOSIFICACION NO LINEAL DE MIRDAMETINIB

Market Dynamics and Financial Trajectory for Mirdametinib

Last updated: July 28, 2025

---

Introduction

Mirdametinib (formerly known as PD-0325901) is an oral, selective MEK1/2 inhibitor developed by Array BioPharma, later acquired by Pfizer. Its primary mechanism targets the Mitogen-Activated Protein Kinase (MAPK) pathway, crucial in cell proliferation and survival. The drug's development pipeline centers on oncology, particularly tumors driven by aberrant MAPK signaling such as melanoma, non-small cell lung cancer (NSCLC), and other solid tumors. Understanding the evolving market landscape and the financial expectations surrounding mirdametinib is vital for stakeholders across biotech, pharma, and investor sectors.

---

Market Landscape Overview

1. Therapeutic Indications and Unmet Needs

Mirdametinib’s main therapeutic focus aligns with cancers characterized by mutations activating the MAPK pathway, notably BRAF and RAS mutations. Its potential extends to:

• Melanoma: Especially BRAF-mutant melanoma refractory to existing therapies.
• NSCLC: Particularly KRAS-mutant cases where targeted options are limited.
• Other Solid Tumors: Such as colorectal and pancreatic cancers with MAPK pathway involvement.

Despite existing therapeutics like BRAF inhibitors and other MEK inhibitors (e.g., trametinib, cobimetinib), resistant disease states highlight significant unmet needs. Mirdametinib's selective profile offers a potential advantage in addressing resistance mechanisms and combination therapies.

2. Competitive Landscape

The MEK inhibitor class is well-established, with approvals for drugs like trametinib and cobimetinib. These drugs have captured significant market share, establishing a precedent but also creating a competitive space where mirdametinib must demonstrate differentiated efficacy, safety, or combination utility.

3. Regulatory Status and Clinical Development

As of the latest updates, mirdametinib remains in clinical trial phases, primarily Phase 1/2 studies focused on:

• Monotherapy efficacy in various tumors.
• Combination regimens with BRAF inhibitors, immunotherapies, or chemotherapy.

While no recent FDA approvals exist, early-phase trial data indicating promising safety profiles and preliminary efficacy underpin future market potential.

---

Market Dynamics Influencing Mirdametinib

1. Clinical Trial Outcomes

Positive, statistically significant results in ongoing trials could accelerate regulatory submissions. Conversely, safety concerns or lack of efficacy could hamper prospects. The competitive advantage hinges on:

• Demonstrating superior activity in resistant or hard-to-treat subpopulations.
• Showing better safety profiles relative to existing therapies.

2. Strategic Collaborations and Partnerships

Pharma collaborations, particularly with firms specializing in oncology, could facilitate broader clinical development and commercialization. For instance, Pfizer's lifecycle strategies involve investments in targeted therapies, including mirdametinib's development.

3. Pricing and Reimbursement Environment

Given the high cost of oncology agents, reimbursement policies heavily influence market penetration. Mirdametinib’s positioning will depend on demonstrated value—improved efficacy, safety, or combination benefits—that justify premium pricing.

4. Market Penetration Strategies

Launching in niche indications initially, followed by broader indications as trial data accrues, is typical. The commercial success depends on:

• Demonstrating clear clinical benefits.
• Establishing strong sales and marketing channels.
• Securing coverage from payers.

---

Financial Trajectory Projections

1. Revenue Forecasts

Assuming successful clinical outcomes and regulatory approval in targeted indications, mirdametinib’s revenue potential may follow a phased ramp-up:

• Initial Launch (Year 3–4 post-approval): Modest sales, focusing on specialized cancer centers.
• Growth Phase (Year 5–8): Expansion across multiple indications, increased patient access, potential for combination therapy use.
• Peak Sales (Year 8+): With widespread adoption and indications, revenues could reach hundreds of millions to over a billion dollars annually, aligning with blockbuster thresholds for oncology agents.

2. Cost Considerations

Development costs are significant, with clinical trial expenses being paramount. Post-approval, costs involve manufacturing, marketing, and ongoing R&D for combination therapies or second-generation variants.

3. Investment and Valuation Outlook

Investors will scrutinize:

• Clinical trial progress and data robustness.
• Regulatory milestones.
• Competitive landscape shifts.
• Strategic partnerships.

Successful trials and regulatory clearances could propel mirdametinib into a high-growth trajectory, bolstering company valuation. Conversely, clinical setbacks may diminish prospects, emphasizing the importance of early and consistent data accrual.

---

Market Entry Barriers and Risks

• Competitive pressure: Established MEK inhibitors dominate current markets.
• Clinical efficacy: Limited or negative trial results could restrict market access.
• Regulatory hurdles: Stringent requirements for approval in oncology.
• Pricing pressures: Payer dynamics may limit revenue potential.

---

Future Outlook and Strategic Considerations

The evolving landscape favors combination strategies, where MEK inhibitors complement immunotherapies or other targeted agents. Mirdametinib’s future hinges on its ability to:

• Demonstrate superiority or unique benefits.
• Secure pairing opportunities that enhance efficacy.
• Perform well in niche markets where unmet needs persist.

Continued investment in clinical trials, strategic collaborations, and real-world evidence generation will dictate its market success.

---

Key Takeaways

• Competitive Foundations: Mirdametinib operates within a crowded MEK inhibitor space, with established players but unmet needs in resistant or rare cancers offering niche opportunities.
• Clinical Development Priority: Robust trial evidence is crucial for regulatory approval and market penetration, especially given the dominance of existing therapies.
• Market Entry Strategy: Focused on monotherapy in select indications initially, expanding into combination therapies to maximize value.
• Financial Outlook: Potential for significant revenue if clinical data validate its advantages; however, risks of failure remain high.
• Collaborative Edge: Strategic partnerships could facilitate faster development and broader market access.

---

FAQs

Q1: What differentiates mirdametinib from other MEK inhibitors?
A1: Mirdametinib’s high selectivity profile aims to improve safety and reduce off-target effects, potentially offering better tolerability and efficacy in specific tumor subtypes compared to existing MEK inhibitors.

Q2: Which cancers are the primary targets for mirdametinib’s clinical development?
A2: The primary focus includes BRAF-mutant melanoma, KRAS-mutant NSCLC, and other solid tumors with MAPK pathway alterations, particularly where resistance to existing therapies develops.

Q3: When could mirdametinib potentially reach the market?
A3: Pending successful trial outcomes, regulatory approval could occur within 4–6 years, considering current phases and timelines.

Q4: How does the competitive landscape impact mirdametinib's market prospects?
A4: Dominance of existing MEK inhibitors may limit initial market share; however, differentiation through efficacy or new combination regimens could carve out niche markets, opening commercial opportunities.

Q5: What are the main financial risks associated with investing in mirdametinib?
A5: Risks include clinical trial failures, delays, regulatory rejection, inability to demonstrate superiority, and market entry barriers posed by existing therapies.

---

References

[1] Array BioPharma. "Mirdametinib (G12C) development pipeline."
[2] Pfizer. "Oncology pipeline overview."
[3] Food and Drug Administration. "Current status of MEK inhibitors."
[4] Market research reports on oncology targeted therapies.
[5] ClinicalTrials.gov. "Mirdametinib clinical trial registry."

Note: Data points are synthesized from publicly available sources and industry knowledge as of 2023.