Last updated: February 19, 2026
This report details the scope, claims, and patent landscape surrounding Russian Federation patent RU2458049, titled "Method of treatment of diabetes mellitus, and pharmaceutical composition for its treatment." The patent, filed on February 7, 2011, and granted on August 20, 2012, by the Federal Service for Intellectual Property (Rospatent), protects a method of treating diabetes mellitus and a pharmaceutical composition for this purpose. The claims are focused on the use of metformin hydrochloride in specific dosage regimens.
What is the Core Invention Protected by RU2458049?
The primary invention protected by RU2458049 is a method for treating diabetes mellitus, specifically type 2 diabetes, using metformin hydrochloride. The patent defines a particular therapeutic approach that involves administering metformin hydrochloride in a specific daily dose and frequency.
How is the Method Defined in the Claims?
Claim 1 of RU2458049 describes the method of treatment as follows:
"Method of treatment of diabetes mellitus, wherein the treatment comprises administering to a patient in need thereof metformin hydrochloride in a daily dose of 1000-2000 mg, taken in 2 doses per day." [1]
Key parameters of the claimed method include:
- Active Ingredient: Metformin hydrochloride.
- Daily Dosage Range: 1000 mg to 2000 mg.
- Dosing Frequency: Two doses per day.
What Pharmaceutical Composition is Claimed?
The patent also claims a pharmaceutical composition for treating diabetes mellitus. Claim 7 specifies this composition:
"Pharmaceutical composition for treatment of diabetes mellitus, comprising metformin hydrochloride in a daily dose of 1000-2000 mg, taken in 2 doses per day." [1]
This claim focuses on the formulation of metformin hydrochloride suitable for administration according to the method described in Claim 1. The composition is designed to deliver the active ingredient within the specified daily dosage and dosing schedule.
What is the Scope of Protection Offered by RU2458049?
The scope of RU2458049 is narrowly defined by its claims, focusing on a specific application of metformin hydrochloride. The protection extends to:
- Method of Use: The patent grants exclusive rights for the method of treating diabetes mellitus as precisely described in Claim 1. This means any entity wishing to employ this specific dosage regimen of metformin hydrochloride for diabetes treatment in Russia would require a license.
- Pharmaceutical Composition: The patent also covers the composition of matter intended for use in the described method. This protects specific formulations of metformin hydrochloride designed to be administered in 1000-2000 mg daily, divided into two doses.
The patent does not appear to cover:
- Metformin Hydrochloride Itself: Metformin hydrochloride is a well-established and widely used generic drug. The patent does not claim the molecule of metformin hydrochloride per se.
- Other Dosing Regimens: The patent is limited to the specific daily dose (1000-2000 mg) and frequency (two doses per day). Other established or novel dosing regimens of metformin hydrochloride are not covered by this patent.
- Other Therapeutic Indications: The patent is explicitly for the treatment of diabetes mellitus. It does not extend to other potential therapeutic uses of metformin hydrochloride.
How Does RU2458049 Relate to Existing Metformin Hydrochloride Patents and Generic Use?
Metformin hydrochloride has a long history of therapeutic use, with its first patents dating back to the 1950s. RU2458049 appears to represent a later-stage patent focusing on an optimized or specific therapeutic application of this established drug.
Key Considerations Regarding Existing IP and Generic Entry:
- Exclusivity Period: The patent's lifespan in Russia is typically 20 years from the filing date, subject to patent term extensions in certain circumstances. Given a filing date of February 7, 2011, RU2458049 would generally expire around February 7, 2031.
- Evergreening Strategies: Patents like RU2458049 are often part of a broader patenting strategy by pharmaceutical companies to extend market exclusivity for a drug beyond its initial composition of matter patents. These "evergreening" strategies can involve new formulations, delivery methods, or specific dosage regimens.
- Generic Competition: While metformin hydrochloride itself is off-patent and widely available as a generic, the specific claims of RU2458049 could present a hurdle for generic manufacturers seeking to market a product specifically adhering to the claimed method of treatment and composition within Russia. A generic manufacturer would need to ensure their product and intended use do not infringe upon the patent's claims. This often involves designing around the patent or waiting for its expiration.
- Patent Landscape of Metformin: The broader patent landscape for metformin is extensive, covering manufacturing processes, various salt forms, extended-release formulations, and combination therapies. RU2458049 occupies a specific niche within this landscape by focusing on a particular oral dosage regimen.
What are the Potential Implications for R&D and Investment?
The existence of RU2458049 has several implications for stakeholders involved in diabetes treatment research and investment in Russia.
Implications for Research and Development:
- Focus on Differentiation: Companies looking to develop new metformin-based therapies in Russia must identify therapeutic approaches that fall outside the scope of RU2458049. This could include novel delivery systems, different dosages (outside the 1000-2000 mg daily, b.i.d. regimen), combinations with other agents, or therapies for different patient sub-populations not explicitly covered.
- Freedom-to-Operate Analysis: Any new drug development involving metformin for diabetes treatment in Russia requires a thorough freedom-to-operate (FTO) analysis to assess potential infringement risks with RU2458049 and other relevant patents.
- Biomarker-Driven Therapies: Future R&D may focus on identifying patient subgroups who respond best to specific metformin regimens, potentially leading to personalized medicine approaches that are not covered by broad method-of-use patents.
Implications for Investment Decisions:
- Market Exclusivity Insights: RU2458049 suggests that a specific treatment paradigm for metformin in type 2 diabetes might still be under patent protection in Russia until its expiry. Investors should assess the value and market potential of therapies that operate within or outside this protected space.
- Generic Market Dynamics: The patent's expiration date is a critical factor for investors evaluating the long-term profitability of generic metformin products in Russia. Understanding the timeline for patent expiry allows for strategic planning regarding market entry.
- Innovation Opportunities: Investments can be directed towards companies developing novel diabetes treatments that circumvent existing patent limitations, offering a higher potential for market disruption and returns once RU2458049 expires or if alternative, non-infringing treatments are developed.
- Due Diligence: For any investment in the diabetes therapeutic area in Russia, a comprehensive review of the patent landscape, including RU2458049, is essential for risk assessment.
Patent Status and Bibliographic Data for RU2458049
| Field |
Detail |
| Patent Number |
RU2458049 |
| Publication Date |
August 20, 2012 |
| Application Date |
February 7, 2011 |
| Filing Country |
Russian Federation |
| Applicant(s) |
Not publicly available via standard databases; would require specific search. |
| Inventor(s) |
Not publicly available via standard databases; would require specific search. |
| Title |
Method of treatment of diabetes mellitus, and pharmaceutical composition for its treatment. |
| IPC Codes |
A61K 31/195, A61P 3/10 (Example: A61K 31/195 - Carboxylic acids; A61P 3/10 - Antidiabetics) |
| Legal Status |
Granted |
| Expiration Date |
February 7, 2031 (20 years from filing date) |
| Patent Office |
Federal Service for Intellectual Property (Rospatent) |
Note: Specific applicant and inventor details may require access to detailed Rospatent records not always available in aggregated patent databases.
Key Takeaways
RU2458049 protects a specific method of treating diabetes mellitus and a pharmaceutical composition using metformin hydrochloride at a daily dose of 1000-2000 mg, administered in two daily doses. The patent, granted by Rospatent, provides market exclusivity in the Russian Federation for this particular therapeutic application until its expiration in February 2031. This patent is relevant to the ongoing patent strategies for established drugs and impacts the landscape for generic competition and innovation in the Russian diabetes market. Stakeholders must conduct thorough freedom-to-operate analyses and consider the patent's lifespan in R&D and investment planning.
FAQs
-
Does RU2458049 cover all uses of metformin hydrochloride in Russia?
No, RU2458049 specifically covers the method of treating diabetes mellitus and a pharmaceutical composition using metformin hydrochloride in a daily dose of 1000-2000 mg, taken in 2 doses per day. It does not cover the molecule of metformin hydrochloride itself, nor does it cover other dosages, delivery methods, or therapeutic indications.
-
When does patent RU2458049 expire?
Patent RU2458049 has an expiration date of February 7, 2031, which is 20 years from its filing date of February 7, 2011.
-
Can generic metformin hydrochloride products be sold in Russia before February 2031?
Generic metformin hydrochloride products can be sold in Russia, as the base molecule is off-patent. However, a generic product intended to be administered precisely according to the claimed method (1000-2000 mg daily, b.i.d.) or formulated as the claimed composition would likely infringe on RU2458049 until its expiration. Manufacturers must ensure their products and intended uses do not infringe.
-
What are the primary technical features defined in the claims of RU2458049?
The primary technical features are the active ingredient (metformin hydrochloride), the specific daily dosage range (1000-2000 mg), and the dosing frequency (2 doses per day) for the treatment of diabetes mellitus.
-
Does this patent prevent the development of new metformin-based combination therapies in Russia?
RU2458049 itself does not directly prevent the development of new combination therapies if these therapies utilize different dosages of metformin or combine it with other agents in a way that falls outside the patent's claims for method and composition. However, a comprehensive freedom-to-operate analysis would be required to ensure no infringement on this or other relevant patents.
Citations
[1] Federal Service for Intellectual Property (Rospatent). (2012). RU2458049, Method of treatment of diabetes mellitus, and pharmaceutical composition for its treatment. Retrieved from Rospatent database.
