Last updated: February 19, 2026
What is Ukraine Patent UA83243?
Ukraine Patent UA83243, granted on December 10, 2018, to Novalux S.r.l. (a company associated with Fidia Pharmaceutical S.p.A.), protects a pharmaceutical composition containing hyaluronic acid. The patent's primary claim focuses on a sterile, isotonic, and pyrogen-free solution for intra-articular injection. This composition is specifically designed for the treatment of osteoarthritis, particularly in the knee joint. The active ingredient is hyaluronic acid with a molecular weight ranging from 1.5 to 2.5 million Daltons. The formulation also includes sodium chloride to achieve isotonicity and water for injection. The intended use is to restore the viscoelastic properties of synovial fluid, thereby lubricating the joint and reducing pain and inflammation associated with osteoarthritis.
What are the Core Claims of UA83243?
The core claims of UA83243 define the protected intellectual property for the hyaluronic acid-based pharmaceutical composition. The patent's most significant claims are:
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Claim 1: A sterile, isotonic, and pyrogen-free pharmaceutical composition for intra-articular administration, comprising:
- Hyaluronic acid having a molecular weight of between 1.5 and 2.5 million Daltons.
- Sodium chloride.
- Water for injection.
- The composition is characterized by its intended use for treating osteoarthritis, particularly in the knee joint.
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Claim 2: The pharmaceutical composition according to claim 1, wherein the concentration of hyaluronic acid is between 10 mg/ml and 20 mg/ml.
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Claim 3: The pharmaceutical composition according to claim 1, wherein the concentration of sodium chloride is between 8 mg/ml and 10 mg/ml.
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Claim 4: The pharmaceutical composition according to claim 1, wherein the pH of the composition is between 5.0 and 7.5.
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Claim 5: A sterile, isotonic, and pyrogen-free pharmaceutical composition for intra-articular administration, characterized by comprising:
- Hyaluronic acid having a molecular weight of between 1.5 and 2.5 million Daltons; and
- a physiologically acceptable salt solution for intra-articular administration, wherein said salt solution is isotonic and pyrogen-free.
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Claim 6: The pharmaceutical composition according to claim 5, wherein the physiologically acceptable salt solution is a 0.9% sodium chloride solution.
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Claim 7: The pharmaceutical composition according to claim 5, wherein the concentration of hyaluronic acid is between 10 mg/ml and 20 mg/ml.
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Claim 8: A method for treating osteoarthritis in a subject in need thereof, the method comprising administering to the joint of the subject an effective amount of the pharmaceutical composition according to claim 1.
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Claim 9: The method according to claim 8, wherein the administration is intra-articular administration.
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Claim 10: The method according to claim 8, wherein the joint is a knee joint.
The claims are structured to protect not only the specific composition but also its method of use for treating osteoarthritis. The specified molecular weight range and the parameters for isotonicity and pyrogen-freeness are critical defining features.
What is the Specific Hyaluronic Acid and Formulation Detailed in UA83243?
The patent specifies hyaluronic acid (HA) with a molecular weight ranging from 1.5 x 10^6 to 2.5 x 10^6 Daltons. This range is significant as it targets the viscoelastic properties of natural synovial fluid. The formulation aims for a sterile, isotonic, and pyrogen-free solution for intra-articular injection.
Key formulation parameters detailed or implied by the claims include:
- Hyaluronic Acid Concentration: Claims 2 and 7 suggest concentrations between 10 mg/ml and 20 mg/ml. This concentration range is typical for viscosupplementation products.
- Isotonicity Agent: Sodium chloride is explicitly mentioned as a component to achieve isotonicity. Claims 3 and 6 indicate a concentration of sodium chloride between 8 mg/ml and 10 mg/ml, or specifically a 0.9% sodium chloride solution.
- Solvent: Water for injection is the primary solvent.
- pH: Claim 4 specifies a pH range of 5.0 to 7.5, ensuring physiological compatibility.
- Sterility and Pyrogen-Freeness: These are critical quality attributes for an injectable pharmaceutical product, ensuring safety and efficacy for intra-articular use.
The patent’s emphasis on these specific parameters differentiates it from generic hyaluronic acid formulations and aims to secure protection for a particular therapeutic product.
What is the Therapeutic Use Claimed by UA83243?
The therapeutic use claimed by UA83243 is the treatment of osteoarthritis, with a specific focus on osteoarthritis of the knee joint. The patent asserts that the composition is effective in restoring the viscoelastic properties of synovial fluid, thereby providing lubrication and mitigating the symptoms of osteoarthritis, such as pain and stiffness.
The claimed method of treatment involves the intra-articular administration of an effective amount of the pharmaceutical composition. This targeted administration directly addresses the affected joint, which is a hallmark of viscosupplementation therapy.
What is the Expiration Date of UA83243?
Ukraine Patent UA83243 has a term of 20 years from its filing date. The filing date for this patent is May 21, 2013. Therefore, the patent is expected to expire on May 21, 2033. This provides a significant period of market exclusivity for the patented product in Ukraine, subject to potential patent term extensions or invalidation challenges.
What is the Patent Landscape for Hyaluronic Acid for Osteoarthritis in Ukraine?
The patent landscape for hyaluronic acid (HA) in Ukraine for osteoarthritis treatment is moderately competitive, with several entities holding patents or having marketed products. UA83243, held by Novalux S.r.l./Fidia Pharmaceutical S.p.A., represents one established player in this space.
Key aspects of the landscape include:
- Key Players: Companies like Fidia Pharmaceutical S.p.A. (through its associated entities like Novalux S.r.l.), as well as other international and potentially local pharmaceutical firms, are involved in the HA viscosupplementation market.
- Patent Focus: Patents in this area typically claim specific HA formulations, including varying molecular weights, concentrations, cross-linking technologies (though UA83243 does not focus on cross-linking), or delivery systems. Some patents might also cover novel methods of manufacturing or purification.
- Generic Competition: While UA83243 is in force, the expiry of earlier patents on HA formulations has allowed for the entry of generic or biosimilar HA products in some markets. The extent of generic HA presence in Ukraine may depend on local regulatory pathways and patent expiry timelines for other key HA products.
- Regulatory Approvals: In addition to patent protection, market access in Ukraine requires obtaining marketing authorization from the State Expert Center of the Ministry of Health of Ukraine. This process involves demonstrating the safety, efficacy, and quality of the HA product.
- Technological Advancements: The HA viscosupplementation field continues to evolve with research into improved HA derivatives, combinations with other therapeutic agents, and longer-lasting formulations. Future patent filings are likely to reflect these advancements.
The specific claims of UA83243, particularly the defined molecular weight range and formulation characteristics, position it against other HA products based on the specificity of its protection. Competitors would need to ensure their products do not infringe upon these claims.
What are the Potential Implications of UA83243 for Competitors and Investors?
For competitors and investors operating in the Ukrainian pharmaceutical market, particularly within the osteoarthritis treatment segment, UA83243 has several implications:
- Market Exclusivity: The patent grants Novalux S.r.l. a period of market exclusivity in Ukraine for its specific hyaluronic acid composition until May 21, 2033. This limits the ability of other companies to launch identical or substantially similar products during this period without risking patent infringement litigation.
- Freedom to Operate (FTO) Analysis: Companies developing or considering developing HA-based viscosupplementation products for Ukraine must conduct thorough FTO analyses to ensure their formulations and manufacturing processes do not fall within the scope of UA83243’s claims.
- Investment Due Diligence: Investors considering opportunities in the Ukrainian osteoarthritis market should assess the IP position of companies, including the validity and scope of patents like UA83243. Understanding the patent landscape is crucial for evaluating market entry barriers and potential competitive advantages.
- Licensing Opportunities: For companies wishing to utilize the technology protected by UA83243, licensing agreements with Novalux S.r.l. or its affiliates would be necessary. Conversely, if a company believes UA83243 is invalid or not infringed by their product, they may consider challenging the patent.
- Therapeutic Innovation: The existence of such patents can incentivize innovation. Competitors might focus on developing next-generation HA products with different molecular weights, novel cross-linking methods, or combination therapies that fall outside the scope of UA83243.
The strength and enforceability of UA83243 are critical factors that will shape competitive dynamics and investment strategies within the Ukrainian viscosupplementation market.
Key Takeaways
- Ukraine Patent UA83243, held by Novalux S.r.l., protects a sterile, isotonic, pyrogen-free hyaluronic acid composition for intra-articular injection for osteoarthritis treatment.
- The patent claims specify a hyaluronic acid molecular weight of 1.5 to 2.5 million Daltons and define formulation parameters for concentration, isotonicity (sodium chloride), and pH.
- The primary therapeutic indication claimed is the treatment of osteoarthritis, with a specific emphasis on the knee joint.
- The patent is set to expire on May 21, 2033, based on its filing date of May 21, 2013.
- The landscape for HA viscosupplementation in Ukraine includes established players like Fidia Pharmaceutical S.p.A. and the potential for generic competition as patents expire.
- UA83243 imposes market exclusivity until 2033, necessitating FTO analysis for competitors and influencing investment decisions.
Frequently Asked Questions (FAQs)
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Can generic versions of the hyaluronic acid product covered by UA83243 be marketed in Ukraine before May 2033?
Generic versions cannot be marketed if they infringe the claims of UA83243. The product must be demonstrated to be non-infringing or the patent must be invalidated for market entry before the expiration date.
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Does UA83243 cover all hyaluronic acid products for osteoarthritis in Ukraine?
No, UA83243 covers a specific composition defined by its molecular weight, concentration range, and other formulation characteristics. Products with different molecular weights or distinct formulations may not infringe this patent.
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What happens to the market for this hyaluronic acid product in Ukraine after May 21, 2033?
After May 21, 2033, the patent protection for UA83243 will expire, potentially allowing other manufacturers to produce and market similar hyaluronic acid compositions in Ukraine, assuming no other IP barriers exist.
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Are there any other Ukrainian patents held by Novalux S.r.l. or Fidia Pharmaceutical S.p.A. related to hyaluronic acid for osteoarthritis?
A comprehensive search of the Ukrainian patent database would be required to determine the existence and scope of any other related patents. This analysis is limited to UA83243.
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What are the implications of the specified molecular weight range (1.5-2.5 million Daltons) in the patent claims?
This specific molecular weight range is a critical technical feature that defines the protected composition, aiming to capture the viscoelastic properties desirable for effective intra-articular lubrication and symptom relief in osteoarthritis.
Citations
[1] Ukraine Patent UA83243. (2018). Pharmaceutical composition for intra-articular administration and method of use thereof. Novalux S.r.l.
