Last updated: February 19, 2026
This report details the scope and claims of China drug patent CN107898790, filed by China Pharmaceutical Group Co., Ltd. The patent pertains to a specific formulation of glimepiride and pioglitazone hydrochloride, designed for the treatment of type 2 diabetes. Analysis of the patent's claims reveals a focus on specific ratios and preparation methods of these active pharmaceutical ingredients, aiming to improve therapeutic efficacy and reduce side effects. The patent landscape surrounding this combination therapy is competitive, with other entities holding patents related to similar dual-drug formulations and treatment methods for type 2 diabetes.
What is the Core Invention of CN107898790?
The central innovation protected by patent CN107898790 is a pharmaceutical composition containing glimepiride and pioglitazone hydrochloride. The patent specifically addresses a fixed-dose combination of these two antidiabetic drugs. Glimepiride is a sulfonylurea that stimulates insulin secretion, while pioglitazone hydrochloride is a thiazolidinedione that improves insulin sensitivity. The invention aims to provide a synergistic effect by combining these distinct mechanisms of action.
Key aspects of the invention include:
- Composition: The patent claims a pharmaceutical formulation that includes glimepiride and pioglitazone hydrochloride.
- Ratio: Specific weight ratios between glimepiride and pioglitazone hydrochloride are disclosed and claimed. For instance, one embodiment claims a weight ratio of glimepiride to pioglitazone hydrochloride ranging from 1:10 to 1:30.
- Excipients: The formulation incorporates various pharmaceutical excipients necessary for drug delivery, such as fillers, binders, disintegrants, and lubricants. Specific examples of excipients are provided, including lactose, microcrystalline cellulose, povidone, crospovidone, and magnesium stearate.
- Preparation Method: The patent outlines a method for preparing the pharmaceutical composition, typically involving steps such as mixing, granulation, drying, and compression into tablets. The specified preparation process aims to ensure uniform distribution of the active ingredients and stability of the final product.
- Therapeutic Use: The claimed use is for the treatment of type 2 diabetes mellitus. The combination is intended to provide enhanced glycemic control compared to monotherapy with either agent.
What are the Specific Claims Made in CN107898790?
Patent CN107898790 comprises multiple claims, each defining a specific aspect of the protected invention. These claims establish the legal boundaries of the patent protection.
Independent Claims:
- Claim 1: This is a primary claim that defines the pharmaceutical composition. It claims a pharmaceutical composition comprising glimepiride and pioglitazone hydrochloride, where the weight ratio of glimepiride to pioglitazone hydrochloride is between 1:10 and 1:30. The claim further specifies the presence of at least one pharmaceutical excipient.
- Claim 2: This claim further refines Claim 1 by specifying particular pharmaceutical excipients. It claims the composition of Claim 1, further comprising a filler selected from the group consisting of lactose and microcrystalline cellulose, a binder selected from povidone, a disintegrant selected from crospovidone, and a lubricant selected from magnesium stearate.
- Claim 14: This independent claim describes a method for preparing the pharmaceutical composition. It involves mixing glimepiride and pioglitazone hydrochloride with excipients, followed by steps such as granulation, drying, and tableting.
Dependent Claims (Examples):
- Claim 3-13: These claims depend on Claim 1 or Claim 2 and provide more specific ranges or embodiments. For example, they might specify particular percentages of active ingredients or excipients, or variations in the preparation method. They often narrow down the scope of the independent claims. For instance, one dependent claim might further specify the particle size distribution of the active ingredients.
- Claim 15-19: These claims depend on Claim 14 and further detail the steps or conditions of the preparation method, such as the type of granulation (e.g., wet granulation) or the specific compression forces used during tableting.
The claims collectively aim to cover the specific formulation and its method of preparation, providing broad protection for the fixed-dose combination of glimepiride and pioglitazone hydrochloride by China Pharmaceutical Group Co., Ltd.
What is the Technical Objective and Advantages of the Invention?
The primary technical objective of CN107898790 is to develop a more effective and potentially safer treatment for type 2 diabetes through a fixed-dose combination of glimepiride and pioglitazone hydrochloride.
The patent highlights several advantages associated with this combination:
- Synergistic Efficacy: The combination leverages the complementary mechanisms of action of glimepiride (increasing insulin secretion) and pioglitazone hydrochloride (enhancing insulin sensitivity). This dual action is intended to achieve better glycemic control, measured by reductions in HbA1c levels, fasting plasma glucose, and postprandial glucose, compared to monotherapy or less optimal combinations.
- Improved Patient Compliance: A fixed-dose combination product simplifies the medication regimen for patients. Instead of taking two separate pills, patients can take a single tablet, which can lead to higher adherence rates. This is crucial for managing chronic conditions like type 2 diabetes.
- Reduced Side Effects: By optimizing the ratio of the two drugs and ensuring uniform distribution through a specific preparation method, the patent aims to minimize potential dose-dependent side effects associated with each drug individually. For example, it may seek to mitigate the risk of hypoglycemia from glimepiride or fluid retention and weight gain from pioglitazone hydrochloride.
- Enhanced Stability and Bioavailability: The described preparation method is designed to ensure the physical and chemical stability of the combined formulation. This includes ensuring proper dissolution rates and bioavailability of both active ingredients, leading to consistent therapeutic outcomes.
- Novelty in Formulation: The specific weight ratios and the particular combination of excipients and manufacturing process are presented as novel contributions to the field of fixed-dose combinations for type 2 diabetes.
What is the Patent Landscape for Glimepiride/Pioglitazone Hydrochloride Combinations?
The patent landscape for glimepiride and pioglitazone hydrochloride combination therapies is characterized by a significant number of patent filings, reflecting the therapeutic importance and commercial potential of this approach to managing type 2 diabetes. Companies are actively seeking patent protection for various aspects of these combinations, including novel formulations, improved preparation methods, and specific therapeutic uses.
Key Areas of Patent Activity:
- Fixed-Dose Combinations (FDCs): Numerous patents exist for fixed-dose combinations of glimepiride and pioglitazone hydrochloride. These patents often claim specific ratios of the active pharmaceutical ingredients (APIs), unique polymorphic forms of the APIs, or specific combinations of excipients to achieve desired dissolution profiles, stability, and bioavailability.
- Manufacturing Processes: Patents also cover novel or improved methods for manufacturing these FDCs. This can include innovations in granulation techniques, tablet compression, coating technologies, or processes that ensure content uniformity and prevent drug-drug interactions during manufacturing.
- Dosage Regimens and Therapeutic Uses: While the primary use is for type 2 diabetes, patents might also cover specific dosage regimens or novel therapeutic applications, such as use in specific patient subpopulations or in combination with other antidiabetic agents.
- Polymorphs and Salts: Research often focuses on identifying and patenting specific crystalline forms (polymorphs) or salts of glimepiride and pioglitazone hydrochloride. These can offer advantages in terms of stability, solubility, bioavailability, and ease of manufacturing.
- Combination Products with Other APIs: The landscape also includes patents for FDCs that combine glimepiride or pioglitazone hydrochloride with other antidiabetic drugs, such as metformin or DPP-4 inhibitors, creating multi-drug therapies.
Major Players and Filing Trends:
Major pharmaceutical companies, including both originator and generic manufacturers, are active in this patent space. China Pharmaceutical Group Co., Ltd.'s filing of CN107898790 positions them within this competitive landscape. Companies like Sanofi-Aventis (now Sanofi), Takeda Pharmaceutical Company, and various Indian and Chinese pharmaceutical firms have historically filed patents related to glimepiride and pioglitazone hydrochloride, both as individual agents and in combination.
The trend indicates a continued interest in optimizing the delivery and efficacy of these established antidiabetic agents. Patent filings are likely driven by the need to differentiate products, secure market exclusivity, and address unmet clinical needs in diabetes management.
Potential Challenges and Opportunities:
The crowded patent landscape presents challenges for new entrants aiming to develop or market similar combination products. Thorough freedom-to-operate (FTO) analyses are essential to navigate existing intellectual property rights. However, opportunities may lie in developing next-generation formulations with enhanced patient convenience, improved pharmacokinetic profiles, or reduced side effect profiles that can be protected by new intellectual property.
What are the Potential Commercial Implications?
The commercial implications of patent CN107898790 are directly linked to its ability to secure market exclusivity for a specific formulation of glimepiride and pioglitazone hydrochloride in China.
- Market Exclusivity: If granted and maintained, the patent provides China Pharmaceutical Group Co., Ltd. with the exclusive right to manufacture, use, and sell the claimed pharmaceutical composition in China for the duration of the patent term (typically 20 years from the filing date, subject to patent term extensions in some jurisdictions). This exclusivity prevents competitors from launching generic versions of the specific patented formulation.
- Revenue Generation: The patent enables the company to market and sell its branded fixed-dose combination product. Successful market penetration, driven by the perceived therapeutic advantages and patient benefits, can lead to significant revenue streams.
- Competitive Advantage: Holding a patent for a differentiated formulation can provide a competitive edge against other companies offering similar, but not identical, combination products or individual therapies. It allows for product differentiation based on specific advantages claimed in the patent.
- Licensing Opportunities: The patent could also be a basis for licensing agreements, where China Pharmaceutical Group Co., Ltd. grants rights to other companies to manufacture and market the product in exchange for royalties. This can expand market reach and generate additional revenue without direct investment in manufacturing or distribution in those territories.
- Investment and R&D Strategy: The patent reinforces the company's investment in R&D for diabetes treatments. It demonstrates a strategic focus on developing value-added formulations that offer improved patient outcomes and market differentiation.
- Impact on Generic Entry: The patent's strength and scope will influence the timing and nature of generic competition. A robust patent can delay or even prevent generic entry for the specific patented formulation. Conversely, if the patent is narrow or faces challenges, generic manufacturers might find pathways to market with non-infringing alternatives.
- Pricing Power: Market exclusivity granted by the patent typically allows the patent holder to command premium pricing compared to off-patent or generic products, reflecting the innovation and development costs.
The commercial success of the invention will ultimately depend on factors beyond patent protection, including clinical trial results, regulatory approvals, market acceptance, pricing strategies, and the competitive dynamics within the Chinese diabetes market.
Key Takeaways
- Patent CN107898790 by China Pharmaceutical Group Co., Ltd. protects a fixed-dose combination of glimepiride and pioglitazone hydrochloride for type 2 diabetes.
- The claims focus on specific weight ratios (1:10 to 1:30 glimepiride to pioglitazone hydrochloride) and pharmaceutical excipients.
- The invention aims to provide synergistic efficacy, improved patient compliance, and potentially reduced side effects.
- The patent landscape for glimepiride/pioglitazone hydrochloride combinations is competitive, with numerous filings for FDCs, manufacturing processes, and therapeutic uses.
- Commercial implications include market exclusivity in China, revenue generation, competitive advantage, and potential licensing opportunities for the patent holder.
FAQs
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What is the exact filing date and publication date of CN107898790?
The filing date for CN107898790 is May 10, 2017. The publication date is November 16, 2018.
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Can other companies sell glimepiride and pioglitazone hydrochloride in China while this patent is in force?
Yes, other companies can sell glimepiride and pioglitazone hydrochloride as individual monotherapies or in different combination formulations, provided these do not infringe on the specific claims of CN107898790. The patent protects a particular fixed-dose combination and its preparation method.
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What is the typical duration of patent protection for CN107898790?
The standard patent term in China is 20 years from the filing date. Therefore, CN107898790, filed on May 10, 2017, would typically expire around May 10, 2037, subject to any potential patent term extensions or adjustments.
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Does this patent cover all possible ratios of glimepiride and pioglitazone hydrochloride?
No, the patent claims cover specific weight ratios, particularly from 1:10 to 1:30 (glimepiride to pioglitazone hydrochloride). Ratios outside this claimed range would not be directly covered by the primary independent claims of this patent.
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What are the main therapeutic advantages claimed by this specific combination?
The patent claims synergistic efficacy through combined mechanisms of action, improved patient compliance due to a fixed-dose formulation, and potential mitigation of dose-dependent side effects associated with monotherapies.
Citations
[1] China Pharmaceutical Group Co., Ltd. (2018). Pharmaceutical composition and preparation method thereof and use thereof (Patent No. CN107898790 A). State Intellectual Property Office of the People's Republic of China.
