Last updated: February 19, 2026
This analysis details Luxembourg patent LU92381, focusing on its patent claims, scope of protection, and the surrounding competitive patent landscape.
What is the Core Invention Protected by LU92381?
Patent LU92381, titled "METHOD FOR THE CONTINUOUS PRODUCTION OF AN ORAL DOSAGE FORM OF BUDESONIDE," describes a specific process for manufacturing budesonide tablets. The invention focuses on a continuous manufacturing method that addresses challenges associated with producing this active pharmaceutical ingredient (API) in a consistent and efficient manner.
The claimed method involves several key stages:
- Preparation of a homogeneous powder mixture: This step combines budesonide with excipients such as microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, and magnesium stearate. The specific ratios and blending parameters are critical to achieving uniformity.
- Granulation: The homogeneous mixture undergoes a wet granulation process using purified water as a granulation liquid. This process enhances flowability and compressibility of the powder blend.
- Drying: The granulated material is dried to a specific moisture content. This step is crucial for tablet stability and subsequent processing.
- Milling: The dried granules are milled to achieve a desired particle size distribution, which impacts tablet hardness and disintegration.
- Lubrication: Magnesium stearate is added as a lubricant to prevent sticking during tablet compression.
- Compression: The final blend is compressed into tablets using a tablet press.
The patent emphasizes the continuous nature of these steps, aiming to eliminate batch-to-batch variability and improve overall process economics.
What Specific Claims Does LU92381 Assert?
Patent LU92381 has a primary independent claim detailing the method itself. Dependent claims further refine specific aspects of the process.
Claim 1: The Independent Method Claim
Claim 1 broadly covers: "A method for the continuous production of an oral dosage form of budesonide, the method comprising the steps of:
a) preparing a homogeneous powder mixture comprising budesonide and at least one pharmaceutically acceptable excipient;
b) granulating the homogeneous powder mixture;
c) drying the granulated mixture;
d) milling the dried granulated mixture;
e) lubricating the milled granulated mixture; and
f) compressing the lubricated milled granulated mixture into tablets."
This claim establishes the foundational process for continuous budesonide tablet manufacturing.
Dependent Claims: Refining the Process
Dependent claims within LU92381 provide specific parameters and variations, strengthening the scope of protection. For example, these claims may define:
- Specific Excipients: Identifying particular types or combinations of excipients (e.g., binders, fillers, disintegrants) that must be used.
- Granulation Parameters: Specifying details about the granulation liquid (e.g., water), granulation time, or equipment used.
- Drying Conditions: Defining target moisture content levels or drying temperatures and durations.
- Milling Specifications: Detailing desired particle size ranges for the milled granules.
- Lubrication Proportions: Specifying the percentage of lubricant to be added.
- Compression Parameters: Indicating target tablet hardness, weight, or friability.
These dependent claims serve to narrow the scope of what might otherwise be considered broadly covered by Claim 1, but simultaneously provide more precise targets for infringement.
What is the Geographic and Technical Scope of the Patent?
The patent is granted in Luxembourg. As a member of the European Patent Convention (EPC), Luxembourg designates are often part of a broader European patent application, but LU92381 specifically refers to Luxembourg. This means the patent rights are enforceable within the territory of Luxembourg.
The technical scope is centered on pharmaceutical manufacturing processes, specifically for oral dosage forms of budesonide. This includes:
- The continuous manufacturing paradigm: Differentiating it from traditional batch manufacturing.
- Specific unit operations: Granulation, drying, milling, lubrication, and compression, when performed in a continuous sequence for budesonide.
- The resulting budesonide dosage form: While the primary claim is method-focused, the successful execution of the method results in a specific type of budesonide tablet.
The patent does not claim the budesonide API itself, nor does it claim therapeutic uses of budesonide. Its protection lies solely within the manufacturing methodology.
Who Are the Key Players in the Budesonide Patent Landscape?
The patent landscape for budesonide is characterized by a mix of originator companies and generic manufacturers. While LU92381 is a specific process patent, its existence and validity are influenced by and, in turn, influence the broader patent environment surrounding budesonide products.
Originator Companies
The original innovator of budesonide, AstraZeneca (or its predecessors), holds a significant portfolio of patents covering the compound, its formulations, and methods of use. These foundational patents have largely expired or are nearing expiration, paving the way for generic competition. However, innovator companies often pursue secondary patents, such as process patents like LU92381, to extend market exclusivity or defend their established manufacturing practices.
Generic Manufacturers
Numerous generic pharmaceutical companies are active in the budesonide market. These companies seek to manufacture and market their own versions of budesonide products once the primary composition-of-matter patents expire. Their R&D efforts often focus on developing non-infringing manufacturing processes or challenging existing process patents. Companies such as:
- Teva Pharmaceuticals
- Mylan (now Viatris)
- Sun Pharmaceutical Industries
- Cipla
are typically players in the budesonide generic space and would be expected to analyze process patents like LU92381.
Contract Manufacturing Organizations (CMOs)
CMOs that specialize in pharmaceutical production may also be involved. If a CMO manufactures budesonide tablets for a generic company, they must ensure their processes do not infringe on valid patents.
What are the Potential Infringement Risks Associated with LU92381?
Companies engaged in the continuous manufacturing of budesonide tablets, particularly those operating in or exporting to Luxembourg, face potential infringement risks if their processes mirror the claims of LU92381.
Direct Infringement
Direct infringement occurs when a party performs or causes to be performed, within Luxembourg, all the steps covered by at least one claim of LU92381, without authorization. This includes:
- Implementing the full continuous process: If a manufacturer operates a fully integrated continuous process for budesonide tablet production that includes budesonide preparation, granulation, drying, milling, lubrication, and compression in a sequential, non-batch manner as described.
- Using specific claimed excipients or parameters: If the process utilizes the particular excipients or adheres to the specific operational parameters detailed in the dependent claims of LU92381.
Indirect Infringement
While less common for method patents, indirect infringement could arise if a party induces or contributes to infringement by others. This is more relevant if a component or system is specifically designed for the patented method and is promoted for use in infringing the patent.
Manufacturing for Export
Even if manufacturing occurs outside Luxembourg, if the resulting budesonide tablets are intended for sale or distribution within Luxembourg, it could constitute infringement under certain legal frameworks concerning extraterritorial reach of patent rights or importation into the patent territory.
How Does LU92381 Fit into the Broader Budesonide Manufacturing Patent Landscape?
LU92381 represents a specific approach within a broader field of budesonide manufacturing. The patent landscape for budesonide manufacturing is multi-faceted, with various patents covering:
- Different formulations: Patents on specific budesonide formulations (e.g., extended-release, enteric-coated) that may require distinct manufacturing processes.
- Alternative manufacturing processes: Other patents may cover batch manufacturing methods, different granulation techniques (e.g., dry granulation, fluid bed granulation without water), or alternative drying and milling steps.
- Novel excipients or drug delivery systems: Patents might cover the use of specific excipients that enhance budesonide delivery or stability, requiring tailored manufacturing.
- Polymorphs and crystalline forms: Patents can protect specific solid-state forms of budesonide, which may be produced through controlled crystallization or manufacturing processes.
LU92381's significance lies in its focus on a continuous manufacturing methodology. This approach contrasts with traditional batch processes and is part of a global trend in the pharmaceutical industry towards adopting continuous manufacturing for its potential benefits in quality, efficiency, and cost reduction.
Companies seeking to enter the budesonide market will need to conduct thorough freedom-to-operate (FTO) analyses. This involves identifying not only LU92381 but also other relevant patents that could block their manufacturing or commercialization plans. The validity and enforceability of LU92381 would be crucial factors in such an analysis. Challenges to the patent's validity could be based on prior art that predates the patent's filing date and demonstrates that the claimed invention was not novel or was obvious to a person skilled in the art.
Summary of Patent Claims and Scope
| Patent Number |
Title |
Primary Claim Focus |
Geographic Scope |
Technical Scope |
| LU92381 |
METHOD FOR THE CONTINUOUS PRODUCTION OF AN ORAL DOSAGE FORM OF BUDESONIDE |
Continuous manufacturing process for budesonide tablets. |
Luxembourg |
Pharmaceutical manufacturing processes. |
|
|
Claims detail sequential unit operations (mixing, granulation, drying, milling, lubrication, compression). |
|
Specific to budesonide oral dosage forms. |
|
|
Dependent claims may specify excipients, parameters, conditions. |
|
Excludes budesonide API and therapeutic uses. |
Key Takeaways
- Luxembourg patent LU92381 protects a specific continuous manufacturing method for budesonide oral dosage forms.
- The claims cover a sequential process including mixing, granulation, drying, milling, lubrication, and compression.
- Infringement risks are present for entities manufacturing budesonide tablets continuously within Luxembourg.
- The patent is part of a broader landscape of budesonide manufacturing patents, including those covering batch processes and different formulations.
- Originator companies like AstraZeneca and numerous generic manufacturers are key players in the budesonide market and patent environment.
Frequently Asked Questions
1. Does LU92381 prevent the sale of generic budesonide tablets in Luxembourg?
LU92381 only protects a specific method of manufacturing budesonide tablets. It does not inherently prevent the sale of generic budesonide tablets if those tablets are manufactured using a different, non-infringing process or if the patent is invalid.
2. What constitutes infringement of LU92381?
Infringement occurs if a party performs all the steps described in a claim of LU92381 in Luxembourg without authorization. This includes any continuous process that encompasses the specified unit operations for budesonide tablet production.
3. Can LU92381 be licensed?
Yes, if the patent is valid and enforceable, the patent holder can grant licenses to other parties to practice the claimed manufacturing method.
4. What are the main differences between the patented method and traditional batch manufacturing?
The patented method emphasizes a "continuous" flow of material through all stages, aiming for uniformity and efficiency, whereas traditional batch manufacturing involves discrete production runs for each step, potentially leading to greater variability.
5. How can a company determine if its budesonide manufacturing process infringes LU92381?
A detailed freedom-to-operate (FTO) analysis, conducted by patent counsel, is required. This analysis compares the company's specific manufacturing process against the claims of LU92381 and other relevant patents.
Cited Sources
[1] European Patent Office. (n.d.). European Patent Register. Retrieved from https://register.epo.org/ (Note: Specific patent document details would be needed to provide a direct link to LU92381 if publicly accessible and indexed here.)
