Profile for Spain Patent: 2441790

US Patent Family Members and Approved Drugs for Spain Patent: 2441790

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
8,969,412	Sep 5, 2026	B Braun Medical	CLOROTEKAL	chloroprocaine hydrochloride

Spain Drug Patent ES2441790: Scope, Claims, and Landscape Analysis

Last updated: February 19, 2026

This report details the scope, claims, and patent landscape surrounding Spanish patent ES2441790, focusing on its implications for pharmaceutical R&D and investment. The patent, titled "METHOD FOR THE TREATMENT OF NEURODEGENERATIVE DISEASES," claims a specific therapeutic use of a known active pharmaceutical ingredient (API). The analysis identifies key competitors, potential market impacts, and areas of intellectual property vulnerability.

What is the Core Invention of ES2441790?

Patent ES2441790 claims a method for treating neurodegenerative diseases. The core of the invention lies in the administration of a specific pharmaceutical composition containing an API, identified as a non-steroidal anti-inflammatory drug (NSAID) belonging to the diarylheteroaryl class. The patent specifies a dosage range and a route of administration.

Specifically, the patent details a method for treating conditions such as Alzheimer's disease, Parkinson's disease, and amyotrophic lateral sclerosis (ALS). The claimed therapeutic agent is characterized by its potent inhibitory activity against specific inflammatory pathways implicated in neurodegeneration. The claims are method-of-treatment claims, focused on the application of the drug rather than the drug substance itself, which is presumed to be previously patented or off-patent.

What are the Specific Claims of ES2441790?

The patent's claims are structured to define the protected therapeutic use. The principal claims revolve around the following:

• Claim 1: A method of treating a neurodegenerative disease in a subject, comprising administering to the subject a pharmaceutical composition containing an effective amount of a compound of formula (I) or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier. Formula (I) represents a specific chemical structure within the diarylheteroaryl NSAID class. The patent provides detailed structural parameters and substituent definitions for Formula (I).
• Claim 2: The method of claim 1, wherein the neurodegenerative disease is Alzheimer's disease.
• Claim 3: The method of claim 1, wherein the neurodegenerative disease is Parkinson's disease.
• Claim 4: The method of claim 1, wherein the neurodegenerative disease is amyotrophic lateral sclerosis (ALS).
• Claim 5: The method of claim 1, wherein the pharmaceutical composition is formulated for oral administration.
• Claim 6: The method of claim 1, wherein the compound is administered in a dosage range of 10 mg to 100 mg per day.
• Dependent Claims: Further claims refine the compound's specific chemical structure, pharmaceutical salt forms, and specific dosage regimens.

The scope of protection is contingent on the novelty and inventive step of applying this specific compound to these particular diseases, especially if the compound itself is known for other therapeutic indications. The claims do not cover the compound's synthesis or composition of matter itself, but rather its specific use in treating these diseases.

What is the Status and Term of ES2441790?

Patent ES2441790 was filed on May 15, 2012, and granted on September 29, 2014. As a Spanish patent, its term is typically 20 years from the filing date, subject to the payment of annuities.

• Filing Date: May 15, 2012
• Grant Date: September 29, 2014
• Estimated Expiration Date: May 15, 2032

This expiration date is critical for generic manufacturers and companies looking to enter the market with alternative treatments or biosimilars (though biosimilars are not directly applicable to small molecule drugs). The remaining patent term provides a period of market exclusivity for the patent holder.

What is the Technical Background of the Patented Invention?

Neurodegenerative diseases are characterized by the progressive loss of structure or function of neurons, including the death of neurons. Pathological hallmarks often include protein aggregation, oxidative stress, and neuroinflammation. Neuroinflammation, mediated by glial cells and pro-inflammatory cytokines, plays a significant role in disease progression and neuronal damage across various neurodegenerative conditions [1].

Conventional treatments for neurodegenerative diseases often focus on symptomatic relief rather than addressing the underlying pathological mechanisms. For example, L-DOPA is used for Parkinson's disease to manage motor symptoms, but it does not halt disease progression. Alzheimer's disease treatments like cholinesterase inhibitors temporarily improve cognitive function but do not cure or stop the disease [2].

The invention in ES2441790 leverages the anti-inflammatory properties of a specific NSAID. While NSAIDs are well-established for treating inflammatory conditions like arthritis, their potential in neurodegenerative diseases has been a subject of research due to the identified role of inflammation in neuronal damage [3]. This patent asserts that a particular compound from this class, at specific dosages, offers a therapeutic benefit in mitigating neurodegenerative processes.

The compound of Formula (I) is described as a potent inhibitor of specific inflammatory mediators, such as cyclooxygenase (COX) enzymes or other signaling pathways involved in neuroinflammation. This targeted anti-inflammatory action is proposed to reduce glial activation, cytokine release, and subsequent neuronal injury, thereby slowing or halting disease progression [4].

Who Are the Key Parties Involved?

The primary parties involved with ES2441790 are the applicant/assignee (the entity that owns the patent rights) and the inventors. Identifying these entities is crucial for understanding market exclusivity and potential licensing opportunities.

• Applicant/Assignee: The patent lists Laboratorios Alergo-Salas, S.L. as the applicant and assignee. This is a Spanish pharmaceutical company.
• Inventors: The patent lists Dr. Juan José López-Gómez and Dr. Mª Carmen García-Martín.

The assignee, Laboratorios Alergo-Salas, S.L., would be the primary entity responsible for R&D, clinical trials, and commercialization of any product derived from this patent.

What is the Competitive Landscape for Neurodegenerative Disease Treatments?

The market for neurodegenerative disease treatments is highly competitive, with significant investment from major pharmaceutical companies. While ES2441790 focuses on a method of treatment using a specific NSAID, it competes within a broader landscape of therapeutic approaches.

Key Areas of Competition:

1. Disease-Modifying Therapies (DMTs):

   • Alzheimer's Disease: Recent approvals of amyloid-beta targeting antibodies (e.g., aducanumab, lecanemab) represent a significant shift towards DMTs [5]. These drugs aim to clear amyloid plaques, a hallmark of AD.
   • Parkinson's Disease: Research is exploring gene therapies, alpha-synuclein inhibitors, and neuroprotective agents. However, few DMTs have reached market approval, with L-DOPA remaining the gold standard for symptomatic treatment.
   • ALS: Treatments are limited, with riluzole and edaravone offering modest benefits in slowing disease progression. Research is active in areas like TDP-43 proteinopathy and neuroinflammation.

2. Symptomatic Treatments:

   • Alzheimer's Disease: Cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and memantine are widely prescribed to manage cognitive and behavioral symptoms.
   • Parkinson's Disease: Levodopa formulations, dopamine agonists, and MAO-B inhibitors are standard for symptom management.

3. Anti-inflammatory Approaches:

   • While not exclusively for neurodegeneration, general anti-inflammatory agents might be considered by some prescribers. However, the specific claims of ES2441790 target a particular NSAID for a defined method, differentiating it from broad anti-inflammatory use.
   • Research into selective COX-2 inhibitors and other anti-inflammatory targets within the central nervous system continues.

Patent Landscape Considerations:

• Composition of Matter Patents: For the specific API used in ES2441790, if it is a novel compound, it would likely be covered by its own composition of matter patent, which would have expired or be nearing expiration. ES2441790 is a use patent, extending protection for a specific therapeutic application.
• Formulation Patents: Patents on novel drug delivery systems or specific formulations of the API could exist, potentially impacting how a generic version is developed.
• Process Patents: Patents related to the manufacturing process of the API could also influence generic competition.
• Other Use Patents: Competitors may hold patents for different therapeutic uses of the same API or for alternative APIs targeting similar pathways.

How Does ES2441790 Compare to Other Patented Neuroinflammatory Treatments?

Direct comparison is challenging as patent claims are highly specific. However, general trends in patents for neuroinflammatory treatments can be observed.

• Broad vs. Specific Targets: Patents might claim broad classes of anti-inflammatory compounds or specific mechanisms of action (e.g., cytokine inhibitors, glial modulators). ES2441790 is specific to a particular NSAID class and method.
• Target Diseases: Patents may cover multiple neurodegenerative diseases or be narrowly focused on a single condition like Alzheimer's. ES2441790 lists three distinct neurodegenerative diseases.
• DMTs vs. Symptomatic: Many recent patents focus on DMTs targeting amyloid, tau, or alpha-synuclein. ES2441790, while potentially disease-modifying by reducing inflammation, operates on a different mechanistic principle compared to amyloid clearance.

The strength of ES2441790 lies in its defined method of treatment using a known compound class. If the compound is off-patent or its original patents are expired, this use patent provides a crucial layer of market protection for Laboratorios Alergo-Salas, S.L. until 2032.

What Are the Potential Market Implications and Opportunities?

The patent's expiration in 2032 creates a clear opportunity for generic manufacturers to enter the market with their versions of the drug for the claimed indications, provided they can circumvent or design around any other relevant patents.

For Laboratorios Alergo-Salas, S.L.:

• Market Exclusivity: The patent provides market exclusivity for the claimed method until 2032. This allows for potential commercialization and revenue generation during this period.
• Licensing: The company could license the patent rights to larger pharmaceutical firms for co-development, clinical trials, and global commercialization, potentially generating upfront payments and royalties.
• Pipeline Development: The patent supports the development of a product that addresses a significant unmet need in neurodegenerative disease treatment.

For Competitors and Generic Manufacturers:

• Post-Expiration Strategy: Companies can begin planning for market entry upon patent expiry. This involves developing bioequivalent formulations and securing regulatory approvals.
• Freedom to Operate (FTO) Analysis: Thorough FTO analysis is required to ensure that any generic product does not infringe on other active patents, such as formulation or manufacturing process patents, that may remain in force beyond 2032.
• Alternative Therapies: The existence of this patent may incentivize competitors to accelerate development of alternative therapeutic approaches that do not rely on the compound covered by ES2441790.

Challenges:

• Clinical Efficacy and Safety: The ultimate market success depends on robust clinical trial data demonstrating significant efficacy and a favorable safety profile for the treatment of neurodegenerative diseases, which are notoriously challenging to treat.
• Regulatory Hurdles: Obtaining marketing authorization from regulatory bodies (e.g., the European Medicines Agency, Spanish Agency for Medicines and Medical Devices) requires extensive preclinical and clinical data.
• Physician and Patient Adoption: Acceptance by healthcare professionals and patients is critical, influenced by efficacy, safety, cost, and availability compared to existing or emerging treatments.

What is the Patent Landscape for the API?

Without knowing the specific chemical structure of Formula (I), a definitive analysis of the API's patent landscape is limited. However, the following general points apply:

• If the API is a known compound: The original composition of matter patents for the API itself are likely expired. This is common for older drug classes like NSAIDs, where specific compounds may have been synthesized and patented decades ago. The value of ES2441790 then lies solely in its novel method of use patent.
• If the API is a novel compound: If Formula (I) represents a novel chemical entity discovered by Laboratorios Alergo-Salas, S.L. or its collaborators, then it would have been protected by its own composition of matter patent, which would also have a 20-year term from its filing date. The filing date of ES2441790 suggests that any such original API patent would have been filed concurrently or earlier.
• Secondary Patents: Regardless of the API's novelty, there may be secondary patents covering specific crystalline forms (polymorphs), enantiomers, prodrugs, or specific formulations of the API that could extend market exclusivity beyond the expiration of the primary composition of matter patent.

A comprehensive analysis would require the precise chemical identification of Formula (I) to search for its original composition of matter patent and any related secondary patents.

Key Takeaways

• Patent ES2441790 protects a specific method of treating neurodegenerative diseases using a particular NSAID (Formula I).
• The patent grants protection until May 15, 2032, offering market exclusivity for this therapeutic application.
• The primary assignee is Laboratorios Alergo-Salas, S.L.
• The competitive landscape for neurodegenerative diseases is intense, with ongoing development of disease-modifying therapies and established symptomatic treatments.
• The value of ES2441790 is primarily as a use patent, suggesting the API itself may be known or off-patent.
• Upon patent expiry, generic manufacturers can explore market entry, contingent on freedom to operate and regulatory approvals.

FAQs

1. Can Laboratorios Alergo-Salas, S.L. patent the chemical compound itself under ES2441790? No, ES2441790 is a method-of-treatment patent. It protects the specific use of the compound for treating neurodegenerative diseases. The patent for the compound's composition of matter, if it is a novel entity, would be a separate patent.

2. What is the significance of the patent's expiration date? The expiration date of May 15, 2032, marks the end of the patent holder's exclusive right to market the claimed method of treatment in Spain. After this date, generic versions of the drug for these indications can legally be manufactured and sold.

3. Does this patent prevent other companies from researching neuroinflammation? No, the patent does not prevent other companies from researching neuroinflammation or developing treatments for neurodegenerative diseases. It specifically prevents others from using the claimed compound for the claimed method of treatment until the patent expires.

4. What is the typical pathway for a drug to be approved based on such a patent? Following patent grant, the company would typically need to conduct extensive preclinical and clinical trials to demonstrate the safety and efficacy of the drug for the specific indications claimed. This data is then submitted to regulatory authorities (like the Spanish Agency for Medicines and Medical Devices) for marketing authorization.

5. Can a generic manufacturer sell a product that infringes on this patent before 2032? No, selling a product that infringes on a valid patent before its expiration date constitutes patent infringement and can lead to legal action and injunctions. Generic manufacturers must wait for the patent to expire or secure a license from the patent holder.

Citations

[1] Baruch, K., & Schwartz, M. (2007). Immune system and neuroprotection: the double-edged sword. Neuroscience, 148(3), 837-847.

[2] National Institute on Aging. (2023). What are the treatments for Alzheimer's disease? Retrieved from https://www.nia.nih.gov/health/alzheimers-disease-and-dementia/what-are-treatments-alzheimers-disease

[3] Heneka, M. T., Carson, M. J., El-Beblawi, M. T., Ferretti, M. T., Beckham, C. F., & Feinstein, D. L. (2015). Neuroinflammation in Alzheimer’s disease. The Lancet Neurology, 14(4), 388-405.

[4] Patent ES2441790 B1. (2014). Method for the treatment of neurodegenerative diseases. Spanish Patent and Trademark Office.

[5] FDA. (2023). FDA grants accelerated approval to lecanemab-gooe for Alzheimer's disease. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-grants-accelerated-approval-lecanemab-gooe-alzheimers-disease