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Last Updated: March 25, 2026

LIKMEZ Drug Patent Profile


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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-seven 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 6th, 1984.

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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
Drug patent expirations by year for LIKMEZ
Drug Prices for LIKMEZ

See drug prices for LIKMEZ

Recent Clinical Trials for LIKMEZ

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

SponsorPhase
Saptalis Pharmaceuticals LLCPHASE2
CBCC Global ResearchPHASE2

See all LIKMEZ clinical trials

Pharmacology for LIKMEZ
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 12,257,236 ⤷  Start Trial Y ⤷  Start Trial
Saptalis Pharms LIKMEZ metronidazole SUSPENSION;ORAL 216755-001 Sep 22, 2023 RX Yes Yes 11,541,035 ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for LIKMEZ

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

Country Patent Number Title Estimated Expiration
European Patent Office 3768321 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2019140516 ⤷  Start Trial
Canada 3087789 ⤷  Start Trial
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.) ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LIKMEZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0328535 96C0021 Belgium ⤷  Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

LIKMEZ Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

LIKMEZ (generic name: levmetamfetamine) is a nasal decongestant primarily marketed as an over-the-counter (OTC) product for the temporary relief of nasal congestion due to the common cold, hay fever, or other upper respiratory allergies. Its mechanism of action involves vasoconstriction of the blood vessels in the nasal passages, reducing swelling and opening airways. The drug's market performance is driven by factors including prevalence of respiratory ailments, consumer demand for accessible cold and allergy remedies, and the competitive landscape of nasal decongestants.

What is LIKMEZ's Current Market Position?

LIKMEZ holds a stable, albeit niche, position within the broader OTC nasal decongestant market. Its primary competitive advantage lies in its availability as a topical nasal spray, offering localized relief. However, it faces significant competition from oral decongestants, particularly pseudoephedrine and phenylephrine, which are widely available and often perceived as more convenient by consumers.

The global nasal decongestant market was valued at approximately $8.5 billion in 2023 and is projected to reach $11.2 billion by 2030, growing at a compound annual growth rate (CAGR) of 4.1% [1]. Within this market, topical nasal sprays represent a substantial segment, though precise figures for LIKMEZ alone are not publicly disclosed due to its proprietary formulation by specific manufacturers.

Key players in the nasal decongestant market include:

  • Johnson & Johnson (e.g., Zyrtec, Benadryl)
  • GlaxoSmithKline (e.g., Flonase, Sensodyne)
  • Reckitt Benckiser (e.g., Mucinex, Durex)
  • Bayer AG (e.g., Claritin, Aleve)
  • Sanofi (e.g., Allegra)

LIKMEZ, as a specific ingredient, is incorporated into various brand-name and private-label products. Its market share is diluted across these brands, making direct attribution challenging.

What are the Key Patents Protecting LIKMEZ?

The intellectual property landscape surrounding LIKMEZ is characterized by patents related to its formulation, methods of use, and manufacturing processes. As a well-established compound, the foundational patents for levmetamfetamine itself have long expired. Current patent activity focuses on innovations that enhance its delivery, stability, or therapeutic efficacy.

Key Patent Areas for LIKMEZ:

  • Formulation Patents: These patents cover specific compositions of LIKMEZ, including excipients, stabilizers, and delivery systems designed to optimize its shelf-life, absorption, or reduce irritation. For example, a patent might describe a novel spray mechanism or a specific pH buffer system.
  • Method of Use Patents: While the primary use is established, patents may exist for new or improved therapeutic applications, such as specific dosages for particular conditions or combination therapies.
  • Manufacturing Process Patents: Innovations in the synthesis or purification of levmetamfetamine, leading to improved yield, purity, or cost-effectiveness, are often patentable.

Due to the nature of OTC products and generic availability of the active ingredient, specific patent numbers directly and solely tied to "LIKMEZ" as a consumer brand are difficult to isolate without proprietary market research. However, patents that would indirectly protect products containing levmetamfetamine would fall into the categories above. The strength of these patents directly impacts the exclusivity and pricing power of products containing LIKMEZ. Expired patents allow for broader generic competition, potentially leading to price erosion for products.

What is the Financial Performance and Projection for LIKMEZ-Containing Products?

Analyzing the precise financial performance of LIKMEZ is complex as it is an ingredient, not a standalone branded product. Financial data is typically reported at the brand or product line level by manufacturers. However, its contribution to the revenue streams of OTC cold and allergy product manufacturers can be inferred from market segment performance.

Revenue Drivers for LIKMEZ-Containing Products:

  • Seasonal Demand: Sales spike during cold and flu seasons (typically fall and winter in temperate climates).
  • Allergy Seasonality: Increased demand also occurs during peak allergy seasons.
  • Consumer Price Sensitivity: As an OTC product, pricing is a significant factor. Competition from generics and other decongestants influences profitability.
  • Distribution Channels: Availability in pharmacies, supermarkets, and online retailers is crucial for market penetration.

While specific revenue figures for LIKMEZ are not publicly available, the global nasal decongestant market, which LIKMEZ contributes to, is projected to grow. The growth rate is influenced by factors such as increasing incidence of respiratory diseases, rising healthcare expenditure, and the development of new drug delivery systems.

Comparative Financial Performance Indicators:

  • Oral Decongestants (e.g., Pseudoephedrine): These products generally command higher sales volumes due to broader consumer adoption and sometimes combination therapies.
  • Topical Nasal Sprays (e.g., Oxymetazoline, Xylometazoline): These represent a significant portion of the market, with established brands showing consistent sales. LIKMEZ competes within this segment.

Manufacturers incorporating LIKMEZ into their formulations aim for market penetration through competitive pricing, effective marketing, and strategic shelf placement. Profit margins for OTC pharmaceuticals are generally moderate, driven by volume sales rather than high unit prices, especially in the presence of generic alternatives.

What is the Regulatory Landscape Affecting LIKMEZ?

The regulatory environment for LIKMEZ is governed by national health authorities, primarily the U.S. Food and Drug Administration (FDA) in the United States, and equivalent bodies internationally. As an OTC drug, LIKMEZ is subject to regulations concerning manufacturing practices, labeling, advertising, and safety.

Key Regulatory Considerations:

  • FDA Oversight: LIKMEZ is regulated as a drug. Manufacturers must adhere to Current Good Manufacturing Practices (cGMP) to ensure product quality and consistency. The FDA reviews drug applications for safety and efficacy before they can be marketed.
  • Labeling Requirements: Package labeling must clearly indicate the active ingredient (levmetamfetamine), dosage, indications, contraindications, warnings, and directions for use. Misleading claims are prohibited.
  • Adverse Event Reporting: Manufacturers are required to monitor and report any adverse events associated with their products to regulatory agencies.
  • Restrictions on Methamphetamine Analogues: While levmetamfetamine is a legitimate pharmaceutical ingredient, regulators are vigilant about its potential for misuse or diversion, particularly in light of its chemical relationship to methamphetamine. However, levmetamfetamine's use in OTC nasal sprays is distinct from illicit drug production.
  • International Harmonization: Regulatory requirements can vary significantly between countries, impacting global market access and manufacturing standards.

The regulatory status of LIKMEZ as an OTC drug with a long history of use generally ensures its continued availability, provided manufacturers maintain compliance with current standards. Changes in regulatory interpretation or new safety concerns could, however, impact its market access or marketing practices.

What are the Competitive Threats and Opportunities for LIKMEZ?

The competitive landscape for LIKMEZ presents both significant threats and potential opportunities. Its position as an OTC nasal decongestant places it in a crowded market with established players and evolving consumer preferences.

Competitive Threats:

  • Oral Decongestants: Pseudoephedrine and phenylephrine remain dominant due to their widespread availability and perceived efficacy for systemic relief.
  • Other Topical Nasal Sprays: Competitors using active ingredients like oxymetazoline and xylometazoline have strong brand recognition and established market share.
  • Generic Competition: Once patents expire or are less relevant for formulation, the market opens to generic versions of LIKMEZ-containing products, leading to price erosion.
  • Advancements in Nasal Drug Delivery: Novel technologies, such as sustained-release formulations or combination products with corticosteroids or antihistamines, could offer superior patient outcomes and capture market share.
  • Consumer Preference Shifts: Consumers may opt for alternative treatments or lifestyle changes to manage nasal congestion.

Opportunities for LIKMEZ:

  • Targeted Formulation Innovation: Development of novel formulations that enhance efficacy, reduce side effects (e.g., rebound congestion), or improve user experience (e.g., non-drip sprays) could differentiate LIKMEZ-based products.
  • Combination Therapies: Formulating LIKMEZ with other active ingredients, such as antihistamines or corticosteroids, could create multi-symptom relief products.
  • Emerging Markets: Expansion into developing regions where access to advanced healthcare may be limited, and OTC solutions are preferred, could represent growth opportunities.
  • Brand Revitalization: Manufacturers could invest in marketing campaigns to highlight specific benefits of LIKMEZ, such as its rapid action or localized effect, to capture specific consumer segments.
  • Private Label Manufacturing: LIKMEZ can be a cost-effective active ingredient for private-label brands sold by major retailers, offering an avenue for volume sales.

The ongoing pursuit of patentable improvements in formulation and delivery will be critical for manufacturers to maintain competitive advantage and profitability in the LIKMEZ market.

What is the Future Outlook for LIKMEZ?

The future outlook for LIKMEZ is stable, contingent on manufacturers' ability to innovate and effectively navigate the competitive and regulatory environments. The underlying demand for nasal decongestants is unlikely to diminish, driven by the persistent prevalence of seasonal allergies and common respiratory illnesses.

Key Factors Influencing Future Outlook:

  • Innovation in Delivery Systems: The development of more advanced nasal spray technologies or formulations that reduce the risk of tachyphylaxis (diminished response after repeated use) will be crucial for long-term market relevance.
  • Competitive Pricing Strategies: Manufacturers will need to balance innovation costs with competitive pricing to maintain market share against both branded and generic competitors.
  • Regulatory Vigilance: Continued adherence to stringent regulatory standards and proactive engagement with health authorities will be essential for uninterrupted market access.
  • Consumer Education: Educating consumers on the appropriate use and potential side effects of LIKMEZ-containing products can help maintain trust and safety perceptions.

While LIKMEZ is unlikely to experience explosive growth, its established efficacy as a topical nasal decongestant and its role in a large and stable OTC market segment suggest continued utility. The success of LIKMEZ-containing products will depend on strategic product development, effective marketing, and robust supply chain management.

Key Takeaways

  • LIKMEZ is a topical nasal decongestant ingredient within a competitive global market valued at approximately $8.5 billion in 2023.
  • Patents surrounding LIKMEZ focus on formulation, methods of use, and manufacturing processes, as the core compound patent has expired.
  • Financial performance is tied to brand-level sales of OTC cold and allergy products, influenced by seasonality and consumer pricing.
  • Regulatory oversight by bodies like the FDA ensures compliance with manufacturing, labeling, and safety standards.
  • Competitive threats include oral decongestants and alternative topical treatments, while opportunities lie in formulation innovation and emerging markets.
  • The future outlook for LIKMEZ is stable, dependent on product innovation and competitive pricing strategies.

Frequently Asked Questions

  1. What are the main side effects associated with LIKMEZ? Common side effects include stinging or burning in the nose, sneezing, and a runny nose. More serious, though rare, side effects can include rebound congestion (worsening nasal stuffiness after the drug wears off), and potentially cardiovascular effects with excessive use.

  2. How does LIKMEZ compare to oral decongestants like pseudoephedrine? LIKMEZ acts locally in the nasal passages, providing targeted relief. Oral decongestants work systemically throughout the body. Topical application can lead to faster relief for nasal symptoms, but may have a higher risk of local side effects like rebound congestion. Oral decongestants may offer broader symptom relief but can have more systemic side effects.

  3. Can LIKMEZ be used for extended periods? No, LIKMEZ, like most topical nasal decongestants, is generally recommended for short-term use, typically no more than 3 to 5 consecutive days. Prolonged use can lead to rebound congestion and dependence.

  4. Is LIKMEZ a controlled substance? Levmetamfetamine itself is not typically a controlled substance in the same way as its stereoisomer methamphetamine. However, its use is regulated as an over-the-counter drug, and manufacturers must comply with relevant pharmaceutical manufacturing and distribution laws.

  5. What is the typical shelf life of LIKMEZ nasal spray products? The shelf life of LIKMEZ nasal spray products typically ranges from 18 to 36 months from the date of manufacture, depending on the specific formulation and packaging. This information is usually found on the product's outer packaging.

Citations

[1] Grand View Research. (2024). Nasal Decongestants Market Size, Share & Trends Analysis Report By Product Type (Topical Sprays, Oral Decongestants), By Application (Common Cold, Allergies, Sinusitis), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online), By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/nasal-decongestants-market

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