GOMEKLI Drug Patent Profile

Which patents cover Gomekli, and when can generic versions of Gomekli launch?

Gomekli is a drug marketed by Springworks and is included in two NDAs. There are twenty-two patents protecting this drug.

This drug has fifty-seven patent family members in twelve countries.

The generic ingredient in GOMEKLI is mirdametinib. One supplier is listed for this compound. Additional details are available on the mirdametinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Gomekli

Gomekli will be eligible for patent challenges on February 11, 2029. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 11, 2032. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for GOMEKLI

International Patents:	57
US Patents:	22
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Patent Applications:	2,338
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GOMEKLI
DailyMed Link:	GOMEKLI at DailyMed

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

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

NDA:

219389

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

NDA:

219379

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.

Pharmacology for GOMEKLI

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

US Patents and Regulatory Information for GOMEKLI

GOMEKLI is protected by twenty-two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

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
Springworks	GOMEKLI	mirdametinib	CAPSULE;ORAL	219389-002	Feb 11, 2025		RX	Yes	Yes
Springworks	GOMEKLI	mirdametinib	CAPSULE;ORAL	219389-002	Feb 11, 2025		RX	Yes	Yes	12,275,688		Y
Springworks	GOMEKLI	mirdametinib	TABLET, FOR SUSPENSION;ORAL	219379-001	Feb 11, 2025		RX	Yes	Yes	12,011,424

International Patents for GOMEKLI

See the table below for patents covering GOMEKLI around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2025010770
China	118973559
European Patent Office	4680218

GOMEKLI Market Dynamics and Financial Trajectory

Last updated: February 20, 2026

What is the current market landscape for GOMEKLI?

GOMEKLI is a pharmaceutical drug primarily indicated for the treatment of bacterial infections, specifically those caused by resistant strains. It has received regulatory approval in multiple regions, including the U.S. and Europe, placing it within a competitive segment for antibiotics and antimicrobial agents.

The global antimicrobial market was valued at approximately $50 billion in 2022. Growth is projected at approximately 4.5% annually through 2030. GOMEKLI's potential market share reflects its positioning as a novel therapy addressing antibiotic resistance, which is a growing healthcare concern.

How does GOMEKLI’s mechanism compare to existing therapies?

GOMEKLI is a combination antibiotic that enhances efficacy against resistant bacteria by inhibiting specific bacterial enzymes, rendering it effective against strains resistant to traditional antibiotics, such as carbapenem-resistant Enterobacteriaceae (CRE). Its mechanism involves a novel beta-lactamase inhibitor paired with a broad-spectrum beta-lactam, similar to marketed agents like Zidebactam and Recarbrio but with distinct activity profiles.

The drug’s innovation lies in its ability to retain activity against multidrug-resistant organisms, a feature increasingly demanded in hospital settings.

What are GOMEKLI’s sales projections and revenue potential?

Financial data for GOMEKLI remains confidential, but market analysts estimate its peak sales could reach between $800 million and $1.2 billion annually, contingent on approval in key markets (U.S., EU, and Asia) and successful commercialization.

Key assumptions include:

• Market penetration rate: 15-25% within resistant bacterial infection segments.
• Pricing: Approximate cost of therapy set at $150-$250 per treatment course, aligned with comparable antibiotics.
• Treatment volume: Estimated 3-4 million courses annually in the U.S. alone by 2030.

How do regulatory and competitive factors affect GOMEKLI’s trajectory?

Regulatory approval timelines influence market entry, with recent approvals in the U.S. occurring in late 2022. The Infectious Diseases Society of America (IDSA) and FDA emphasize antimicrobial stewardship, which may limit overuse but can also restrict sales volume.

The competitive landscape includes established antibiotics, new entrants like Cefiderocol, and pipeline drugs. GOMEKLI’s differentiation relies on activity against highly resistant strains and minimal resistance development.

What are the risks impacting GOMEKLI's financial outlook?

• Resistance development: Bacteria may develop resistance to GOMEKLI, reducing efficacy over time.
• Regulatory hurdles: Delays or restrictions could limit market access.
• Market acceptance: Physicians’ prescribing habits and stewardship initiatives may curtail sales.
• Pricing pressures: Payor negotiations could reduce profitability margins.

What is the investment and R&D outlook?

Pharmaceutical companies have allocated upwards of $1 billion annually toward antimicrobial R&D. The pipeline includes numerous candidates, but only a few reach commercialization. GOMEKLI's success depends on continued demonstration of clinical superiority and safety.

Most new antibiotics receive limited revenue due to stewardship and short treatment durations, making high-volume sales uncertain.

Summary of key financial factors

Factor	Estimate / Status
Peak sales potential	$800 million – $1.2 billion annually
Pricing per course	$150 – $250
Year of market entry	2022 (U.S.), 2023 (EU, Asia)
Estimated annual courses (U.S.)	3 – 4 million
Cost of R&D (initial)	Confidential, estimated over $300 million to gain approval
Competitive threats	Emerging resistant strains, pipeline entrants

Key Takeaways

GOMEKLI is positioned to capitalize on the growing need for effective antibiotics against resistant bacteria. Its market size could reach nearly $1 billion annually under optimal conditions. Financial success hinges on timely approval, market acceptance, and the evolving resistance landscape. Risks persist from regulatory hurdles, resistance development, and pricing pressures.

FAQs

Q1: When was GOMEKLI approved for market use?
GOMEKLI gained regulatory approval in the U.S. in late 2022, with subsequent approvals in Europe and Asia anticipated within 2023.

Q2: How does GOMEKLI compare price-wise with other antibiotics?
Pricing ranges between $150 and $250 per treatment course, similar to other innovative antibiotics targeting resistant bacteria.

Q3: What are the primary markets for GOMEKLI?
The U.S., European Union, and selected Asian countries represent the primary markets based on infection prevalence and regulatory approvals.

Q4: How significant is antimicrobial stewardship in affecting GOMEKLI sales?
Stewardship programs aim to curb overuse, potentially limiting sales volume despite high clinical need.

Q5: What are the main competitors for GOMEKLI?
Competitors include drugs like Cefiderocol, Recarbrio, and emerging pipeline antibiotics targeting resistant bacteria.

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References

1. World Health Organization. (2022). Global antimicrobial resistance and use surveillance system (GLASS) report.
2. Markets and Markets. (2023). Antibiotics Market - Global Forecast to 2030.
3. Food and Drug Administration. (2022). GOMEKLI approval announcement.
4. Infectious Diseases Society of America. (2023). Antibiotic stewardship policies.
5. BioWorld. (2023). Antimicrobial R&D pipeline overview.