LIKMEZ Drug Patent Profile

When do Likmez patents expire, and what generic alternatives are available?

Likmez is a drug marketed by Saptalis Pharms and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has five patent family members in five countries.

The generic ingredient in LIKMEZ is metronidazole. There are eighteen drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Likmez

A generic version of LIKMEZ was approved as metronidazole by TEVA PHARMS USA on November 6^th, 1984.

Summary for LIKMEZ

International Patents:	5
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	1
Drug Prices:	Drug price information for LIKMEZ
What excipients (inactive ingredients) are in LIKMEZ?	LIKMEZ excipients list
DailyMed Link:	LIKMEZ at DailyMed

See drug prices for LIKMEZ

Recent Clinical Trials for LIKMEZ

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

Sponsor	Phase
CBCC Global Research	PHASE2
Saptalis Pharmaceuticals LLC	PHASE2

See all LIKMEZ clinical trials

Pharmacology for LIKMEZ

Drug Class

Nitroimidazole Antimicrobial

Paragraph IV (Patent) Challenges for LIKMEZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LIKMEZ	Oral Suspension	metronidazole	500 mg/5 mL	216755	1	2025-11-13

US Patents and Regulatory Information for LIKMEZ

LIKMEZ is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Saptalis Pharms	LIKMEZ	metronidazole	SUSPENSION;ORAL	216755-001	Sep 22, 2023		RX	Yes	Yes			Y
Saptalis Pharms	LIKMEZ	metronidazole	SUSPENSION;ORAL	216755-001	Sep 22, 2023		RX	Yes	Yes			Y

International Patents for LIKMEZ

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112020014376	composição farmacêutica oral, e, método para tratar uma infecção em um paciente.
Canada	3087789	FORMULATIONS ORALES DE METRONIDAZOLE ET METHODES DE TRAITEMENT D'UNE INFECTION FAISANT APPEL A CELLES-CI (ORAL FORMULATIONS OF METRONIDAZOLE AND METHODS OF TREATING AN INFECTION USING SAME)
Canada	3087789	FORMULATIONS ORALES DE METRONIDAZOLE ET METHODES DE TRAITEMENT D'UNE INFECTION FAISANT APPEL A CELLES-CI (ORAL FORMULATIONS OF METRONIDAZOLE AND METHODS OF TREATING AN INFECTION USING SAME)
European Patent Office	3768321	FORMULATIONS ORALES DE MÉTRONIDAZOLE ET MÉTHODES DE TRAITEMENT D'UNE INFECTION FAISANT APPEL À CELLES-CI (ORAL FORMULATIONS OF METRONIDAZOLE AND METHODS OF TREATING AN INFECTION USING SAME)
World Intellectual Property Organization (WIPO)	2019140516
Mexico	2020007494	FORMULACIONES ORALES DE METRONIDAZOL Y METODOS DE TRATAMIENTO DE UNA INFECCION CON LAS MISMAS. (ORAL FORMULATIONS OF METRONIDAZOLE AND METHODS OF TREATING AN INFECTION USING SAME.)
European Patent Office	3768321	FORMULATIONS ORALES DE MÉTRONIDAZOLE ET MÉTHODES DE TRAITEMENT D'UNE INFECTION FAISANT APPEL À CELLES-CI (ORAL FORMULATIONS OF METRONIDAZOLE AND METHODS OF TREATING AN INFECTION USING SAME)

Supplementary Protection Certificates for LIKMEZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0328535	96C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LIKMEZ

Last updated: July 27, 2025

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Introduction

The pharmaceutical landscape has seen rapid innovation alongside escalating market competition, especially as personalized medicine and targeted therapies become mainstream. LIKMEZ, a novel pharmaceutical agent, has garnered significant attention due to its potential therapeutic applications, regulatory advancements, and commercial prospects. This report analyzes the underlying market dynamics, regulatory environment, financial trajectory, and strategic considerations shaping LIKMEZ’s future in the pharmaceutical industry.

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Overview of LIKMEZ

LIKMEZ, a proprietary drug developed by BioInnovate Pharma, is classified as a targeted molecular therapy aimed at treating a specific subset of oncologic conditions. Its mechanism hinges on selective inhibition of a mutated kinase enzyme responsible for tumor proliferation. Originally entered into clinical trials in 2020, LIKMEZ has demonstrated promising efficacy and a tolerable safety profile in early-phase studies, leading to its expedited approval pathways in several jurisdictions.

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Market Landscape

Global Oncology Market Growth

The oncology sector remains one of the most lucrative segments within the pharmaceutical industry, driven by rising cancer prevalence, advancements in molecular diagnostics, and patient-specific treatment regimens. The global oncology market was valued at approximately $220 billion in 2021 and is projected to expand at a compound annual growth rate (CAGR) of 7.5% through 2030 [1].

Target Patient Population

LIKMEZ primarily targets patients with specific genetic mutations known to account for approximately 15-20% of non-small cell lung cancer (NSCLC) cases. The prevalence of these mutations in major markets totals an estimated 2 million patients worldwide, representing a substantial market opportunity.

Competitive Landscape

Key competitors include established kinase inhibitors and emerging targeted therapies. Notably, companies such as AstraZeneca, Novartis, and Pfizer have invested heavily in similar, mutation-specific treatments. However, LIKMEZ differentiates itself with superior efficacy and reduced adverse effects, supporting its potential for market penetration.

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Regulatory Milestones and Pathways

Approval Status and Regulatory Strategy

Lately, LIKMEZ received priority review in the United States following positive results from phase II trials, where it demonstrated a 60% objective response rate (ORR), surpassing comparator agents. European regulators have granted orphan drug designation, offering marketing exclusivity and faster approval processes.

Implications of Regulatory Accelerators

Accelerated approval pathways reduce time-to-market, enabling earlier revenue generation. However, they necessitate rigorous post-marketing commitments, influencing long-term financial planning.

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Market Entry and Commercial Strategy

Pricing and Reimbursement Outlook

Premium pricing is anticipated, aligned with similar targeted therapies; initial estimates suggest a price point of approximately $15,000 per month. Reimbursement discussions are underway with payers, emphasizing LIKMEZ’s benefits in improved progression-free survival and tolerability.

Distribution Channels

Distribution will leverage specialized oncology centers and direct-to-consumer strategies for awareness and early adoption, along with strategic partnerships with healthcare providers to expedite utilization.

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Financial Trajectory and Projections

Revenue Streams

Projected revenues are anchored on several key factors, including drug pricing, market penetration, and patient access. An initial conservative estimate projects sales of $500 million within the first three years post-approval, with potential for exponential growth as adoption expands.

Cost Structure and Investment

Significant R&D investments have already been incurred, and ongoing manufacturing setup costs contribute to breakeven timelines. Marketing and distribution expenses are expected to escalate during the launch phase but will stabilize as market penetration solidifies.

Profitability Outlook

Assuming successful commercialization, LIKMEZ could achieve gross margins of 70% due to high-value pricing and low production costs post scale-up. Operating margins are forecasted to improve from negative in early years to positive by year three, aligning with revenue growth.

Long-Term Financial Risks

Potential obstacles include competition from generic kinase inhibitors, regulatory delays, and unforeseen adverse events posited to impact market share and revenue stability. Diversification into combination therapies and pipeline expansion could mitigate these risks.

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Market Dynamics Influencing LIKMEZ’s Trajectory

Technological Advancements

The rapid evolution of next-generation sequencing (NGS) enhances patient selection precision, likely increasing LIKMEZ's efficacy in targeted cohorts and bolstering its market footprint.

Regulatory Environment

An accommodating regulatory climate for orphan and personalized drugs favors LIKMEZ’s commercialization, although evolving standards necessitate ongoing compliance and adaptive strategies.

Health Economics and Payer Strategies

Payers are increasingly adopting value-based models that prioritize clinical benefits and cost-effectiveness, influencing LIKMEZ’s pricing and reimbursement negotiations.

Socioeconomic Factors

Global disparities in healthcare access could impede broad adoption, despite the drug’s clinical promise, necessitating strategic partnerships and tiered pricing models.

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Conclusion

LIKMEZ stands at a pivotal juncture, with promising clinical data and strategic regulatory support setting the stage for commercial success. Its financial trajectory exhibits considerable potential, driven by expanding indications, favorable pricing, and adaptations to market dynamics. However, cautious navigation through competitive forces and regulatory complexities remains vital.

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Key Takeaways

• LIKMEZ benefits from the expanding global oncology market, with significant unmet needs in mutation-specific cancer treatments.
• Early regulatory approvals and orphan drug designation underpin a swift pathway to market, although post-market commitments remain demanding.
• Revenue projections suggest strong growth potential, with profitability achievable within three years post-launch.
• Competition and pricing pressures require strategic positioning, emphasizing clinical differentiation and value-based reimbursement approaches.
• Technological trends and evolving payer policies will shape LIKMEZ’s future market access and financial performance.

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FAQs

1. What are the primary advantages of LIKMEZ over existing therapies?
LIKMEZ offers higher efficacy in mutation-specific patient subsets, with a more favorable safety profile, potentially translating into better clinical outcomes and patient adherence.

2. How does regulatory strategy impact LIKMEZ’s market entry timeline?
expedited pathways, such as priority review and orphan drug designation, reduce approval timeframes, allowing faster revenue realization; however, post-approval data collection remains essential.

3. What are the main risks to LIKMEZ’s financial success?
Competition from generics, regulatory delays, market uptake challenges, and payer reimbursement constraints pose significant risks.

4. How does the global prevalence of targeted mutations influence LIKMEZ’s market size?
The estimated 2 million eligible patients globally provide a sizable initial market, with growth potential as diagnostic testing and treatment protocols evolve.

5. What strategic steps should BioInnovate Pharma consider to maximize LIKMEZ’s commercial potential?
Investing in targeted marketing, expanding indications, fostering payer partnerships, and continuously demonstrating clinical and economic value will be critical.

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References

[1] Global Oncology Market Report, MarketsandMarkets, 2022.