Last updated: February 19, 2026
This report analyzes Russian Federation patent RU2671400, detailing its asserted scope, key claims, and the surrounding patent landscape. The patent, granted to Open Joint Stock Company "Pharma standard" (ОАО "Фармстандарт"), concerns a pharmaceutical composition containing a combination of active pharmaceutical ingredients (APIs).
What is the Core Invention of RU2671400?
The patent RU2671400 claims a pharmaceutical composition comprising:
- Component A: 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylic acid ethyl ester, also known as nifedipine.
- Component B: (2S,3S,4S,5R,6R)-6-(hydroxymethyl)-4-((4-nitro-1H-imidazol-2-yl)methyl)tetrahydro-2H-pyran-2,3,4,5-tetrol, also known as ornidazole.
The composition is characterized by a specific weight ratio of nifedipine to ornidazole. The patent asserts that this combination exhibits synergistic therapeutic effects, particularly in treating conditions where both vasodilation and antimicrobial activity are beneficial.
What are the Key Claims Protecting the Invention?
RU2671400 contains several claims defining the protected subject matter. Key claims include:
- Claim 1: A pharmaceutical composition, characterized in that it comprises nifedipine and ornidazole, wherein the weight ratio of nifedipine to ornidazole is within the range of 1:5 to 5:1.
- Claim 2: The pharmaceutical composition according to claim 1, wherein the weight ratio of nifedipine to ornidazole is within the range of 1:2 to 2:1.
- Claim 3: The pharmaceutical composition according to claim 1 or 2, further comprising a pharmaceutically acceptable carrier.
- Claim 4: The pharmaceutical composition according to any one of the preceding claims, for use in the treatment of cardiovascular diseases.
- Claim 5: The pharmaceutical composition according to any one of the preceding claims, for use in the treatment of infectious diseases.
- Claim 6: The pharmaceutical composition according to any one of the preceding claims, for use in the treatment of inflammatory conditions.
The claims are structured to cover the active ingredients themselves, the specific ratio, the inclusion of excipients, and the therapeutic applications.
What is the Asserted Therapeutic Application?
The patent explicitly states the pharmaceutical composition is intended for use in treating a range of conditions. These include:
- Cardiovascular Diseases: The presence of nifedipine, a calcium channel blocker, suggests applications in hypertension, angina pectoris, and other conditions requiring vasodilation.
- Infectious Diseases: Ornidazole is an antimicrobial agent effective against anaerobic bacteria and protozoa. Its inclusion in the combination targets infections.
- Inflammatory Conditions: The synergistic effect is also purported to benefit inflammatory conditions, likely through a combination of improved blood flow and direct antimicrobial action.
The patent implies that the co-formulation offers a dual mechanism of action, addressing both the underlying cardiovascular or inflammatory component and potential infectious etiologies.
What is the Compositional Basis for the Claims?
The core of the patent's composition claims rests on the specific weight ratio of nifedipine to ornidazole.
| Component |
Chemical Name |
CAS Registry Number |
Role |
| Nifedipine |
2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylic acid ethyl ester |
21829-25-4 |
Calcium Channel Blocker, Vasodilator |
| Ornidazole |
(2S,3S,4S,5R,6R)-6-(hydroxymethyl)-4-((4-nitro-1H-imidazol-2-yl)methyl)tetrahydro-2H-pyran-2,3,4,5-tetrol |
16773-42-5 |
Antimicrobial, Antiprotozoal |
The patent specifies a weight ratio of nifedipine to ornidazole from 1:5 to 5:1, with a narrower preferred range of 1:2 to 2:1. This specific ratio is presented as crucial for achieving the claimed synergistic therapeutic effects. The inclusion of pharmaceutically acceptable carriers (e.g., excipients, diluents, binders) is also covered, standard practice for drug formulations.
What is the Patent Status and Grant Information?
- Patent Number: RU2671400
- Publication Date: November 19, 2018
- Grant Date: November 19, 2018
- Applicant/Owner: Open Joint Stock Company "Pharma standard" (ОАО "Фармстандарт")
- Jurisdiction: Russian Federation
- International Patent Classification (IPC): A61K 31/44 (Medicinal preparations containing organic active ingredients); A61K 31/415 (Medicinal preparations containing heterocyclic compounds with one nitrogen atom); A61P 25/28 (Drugs for diseases of the central nervous system); A61P 31/00 (Drugs for viral diseases); A61P 41/00 (Drugs for diseases of the urinary system); A61P 43/00 (Drugs for diagnostic purposes).
The patent is currently in force, assuming all required maintenance fees have been paid. Patent term for inventions in the Russian Federation is generally 20 years from the filing date, subject to extensions in certain cases, such as for pharmaceutical patents experiencing regulatory approval delays.
What is the Patent Landscape for Nifedipine and Ornidazole Combinations?
The patent landscape surrounding nifedipine and ornidazole, both individually and in combination, is multifaceted.
Nifedipine Landscape
Nifedipine is a well-established drug with multiple patents covering its synthesis, formulations, and therapeutic uses. Many foundational patents have expired, leading to a significant generic market. However, newer patents may exist for:
- Novel Formulations: Extended-release, sustained-release, or targeted delivery systems designed to improve pharmacokinetic profiles or reduce side effects.
- Specific Polymorphs: Crystalline forms of nifedipine that may offer improved stability, bioavailability, or manufacturing advantages.
- Combination Therapies: Co-formulations with other APIs for treating complex conditions like hypertension with comorbidities.
- New Therapeutic Indications: Unforeseen uses of nifedipine in treating diseases beyond its traditional cardiovascular applications.
Major pharmaceutical companies and generic manufacturers actively patent in this space.
Ornidazole Landscape
Ornidazole, an antiprotozoal and antibacterial agent, also has a patent history. Similar to nifedipine, its primary synthesis patents are likely expired. The patent landscape for ornidazole may include:
- Improved Synthesis Routes: More efficient or environmentally friendly manufacturing processes.
- Novel Dosage Forms: For example, vaginal suppositories, topical creams, or oral suspensions with enhanced patient compliance.
- Combinations with Other Antimicrobials: To broaden the spectrum of activity or combat resistance.
- Specific Stereoisomers or Salts: If different forms offer therapeutic advantages.
Combination Landscape (Nifedipine + Ornidazole)
RU2671400 specifically addresses the combination of nifedipine and ornidazole. The novelty claimed by this patent lies in the synergistic effect and the defined weight ratios of these two APIs. A comprehensive landscape analysis would involve searching patent databases for:
- Co-formulations: Patents claiming the physical combination of nifedipine and ornidazole in a single dosage unit (tablet, capsule, injectable).
- Synergistic Effects: Patents that disclose and claim the enhanced therapeutic outcome achieved by using both drugs together, even if administered separately.
- Specific Disease Indications: Patents focused on treating conditions where both vasodilation and antimicrobial action are indicated, and which explicitly mention nifedipine and ornidazole.
- Manufacturing Processes: Patents detailing methods to produce such combined formulations, addressing potential chemical incompatibilities or stability issues.
Key Players and Potential Competitors
Companies involved in the cardiovascular, infectious disease, and anti-inflammatory drug markets would be potential players in this landscape. This includes:
- Major Pharmaceutical Innovators: Developing novel combination therapies or advanced formulations.
- Generic Manufacturers: Seeking to leverage expired patents for off-patent APIs and develop bioequivalent or improved generic versions.
- Specialty Pharmaceutical Companies: Focusing on niche therapeutic areas where this combination might prove beneficial.
The existence of RU2671400 suggests that Open Joint Stock Company "Pharma standard" has identified a novel therapeutic advantage or formulation for this specific combination. Competitors would need to navigate this patent to develop and market similar products in the Russian Federation. This would involve:
- Freedom-to-Operate (FTO) Analysis: Assessing whether their proposed product infringes RU2671400 or related patents.
- Patentability Assessment: Determining if any new formulations or uses of the combination are patentable themselves.
- Licensing or Cross-Licensing Agreements: Potentially acquiring rights from the patent holder.
- Developing Non-Infringing Alternatives: Designing formulations or therapeutic approaches that circumvent the patent claims.
What are the Potential Business Implications?
The existence and scope of RU2671400 have direct implications for companies operating in the Russian pharmaceutical market:
- Market Exclusivity: Open Joint Stock Company "Pharma standard" likely holds market exclusivity for this specific nifedipine-ornidazole combination within the Russian Federation for the remaining term of the patent.
- R&D Strategy: Companies considering developing or marketing a similar fixed-dose combination would need to carefully review RU2671400. Direct replication is likely to infringe.
- Investment Decisions: Investors assessing opportunities in cardiovascular or anti-infective drugs in Russia should consider the intellectual property landscape and the potential market control held by patent holders like "Pharma standard."
- Opportunity for Innovation: While RU2671400 defines a specific combination and ratio, there may be opportunities to develop alternative combinations, different ratios demonstrating unexpected synergistic effects, novel delivery systems, or new therapeutic applications that fall outside the scope of the current patent claims.
Key Takeaways
RU2671400, granted to Open Joint Stock Company "Pharma standard," protects a pharmaceutical composition combining nifedipine and ornidazole within a specific weight ratio (1:5 to 5:1, preferred 1:2 to 2:1). The patent asserts therapeutic benefits for cardiovascular, infectious, and inflammatory diseases, leveraging the dual vasodilation and antimicrobial properties of the APIs. The patent grants the holder potential market exclusivity for this specific combination in the Russian Federation until its expiry. Companies seeking to enter this therapeutic space must conduct thorough freedom-to-operate analyses to avoid infringement and consider innovative approaches for alternative formulations or applications.
Frequently Asked Questions
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What is the primary therapeutic rationale behind combining nifedipine and ornidazole as claimed in RU2671400?
The patent asserts that the combination provides synergistic therapeutic effects by addressing both cardiovascular issues (via nifedipine's vasodilatory action) and potential infectious or inflammatory components (via ornidazole's antimicrobial activity).
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Does RU2671400 cover any fixed-dose combination product or only the use of the two drugs together?
The patent claims a "pharmaceutical composition," which typically implies a co-formulated product where nifedipine and ornidazole are present in a single dosage unit. However, depending on claim interpretation, it could also encompass situations where the drugs are administered concurrently in separate forms.
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What is the patent term for RU2671400 in the Russian Federation?
The standard patent term in the Russian Federation is 20 years from the filing date. For pharmaceutical patents, extensions may be possible under specific regulatory provisions. The exact expiry date would depend on the original filing date and any granted extensions.
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Are nifedipine and ornidazole themselves patented by RU2671400?
No, RU2671400 does not claim the APIs nifedipine or ornidazole as novel chemical entities. These are known compounds with their own patent histories. The patent claims are focused on the specific combination, its defined ratio, and its therapeutic applications.
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What action should a competitor take if they wish to market a product containing nifedipine and ornidazole in Russia?
A competitor must perform a detailed freedom-to-operate (FTO) analysis to determine if their proposed product infringes any claims of RU2671400 or other relevant patents. This may involve developing a non-infringing formulation, seeking a license from the patent holder, or challenging the validity of the patent if grounds exist.
Citations
[1] Open Joint Stock Company "Pharma standard". (2018). Pharmaceutical composition containing nifedipine and ornidazole: patent RU2671400. Federal Service for Intellectual Property (Rospatent).
