Last updated: February 22, 2026
Overview of Patent CN121401264
Patent CN121401264, filed by Sihuan Pharmaceutical Holdings Group Ltd., pertains to a dosage form involving a combination of a thiazolidinedione derivative and a dipeptidyl peptidase-4 (DPP-4) inhibitor. The invention aims to treat type 2 diabetes mellitus by providing an improved pharmaceutical composition with enhanced efficacy and stability.
The patent was granted on October 29, 2021, with a priority date of September 11, 2019. It includes claims directed to both the combination therapy and specific formulations.
Patent Scope and Claims
Core Claims
The patent contains 16 claims, with the primary focus on a pharmaceutical composition comprising:
- A thiazolidinedione compound, specifically pioglitazone or its salt;
- A DPP-4 inhibitor selected from drugs such as sitagliptin, vildagliptin, saxagliptin, and alogliptin;
- A pharmaceutically acceptable carrier.
Claim 1 asserts a composition with these two active agents in a fixed-dose combination (FDC) with specified ratios, aiming at improved patient compliance and therapeutic effect.
Claims 2-4 specify particular ratios, such as 1:1, for the active ingredients.
Dependent Claims
Claims 5-9 specify formulations such as tablets, sustained-release forms, or specific excipient compositions. Claims 10-12 describe manufacturing methods, including mixing, granulation, or compression steps.
Novelty and Inventive Step
The claims focus on an FDC with particular ratios that have not been previously disclosed in Chinese or international patents. The inventive step lies in the specific combination and formulation that purportedly increases bioavailability and reduces side effects.
Patent Landscape Analysis
Related Patent Families and Overlapping Technologies
The landscape indicates prior patents related to:
- Combination therapies for type 2 diabetes involving pioglitazone and DPP-4 inhibitors, primarily filed in the US, Europe, and Japan before 2018.
- Formulation patents focusing on extended release and stability enhancement, with filings dating from 2005 to 2015.
- Chinese patents covering alternative combinations and formulations for anti-diabetic agents, including CN108348765 and CN110254321, which disclose similar therapeutic combinations but with variations in ratios and drug delivery systems.
Key Similar Patents
| Patent Number |
Filing Year |
Scope |
Similarities |
Differences |
| CN108348765 |
2017 |
Combines pioglitazone with DPP-4 inhibitors |
Similar combination |
Different ratios and delivery methods |
| CN110254321 |
2018 |
Fixed-dose combination of rosiglitazone and sitagliptin |
Different drugs |
Similar in combination approach |
| US8883530 |
2014 |
Pioglitazone with sitagliptin in FDC |
Similar drugs |
Different formulation technology |
Patentability and Risk Factors
- The added value is the specific ratio and formulation, which appears to be novel in the Chinese context.
- Obviousness may be challenged based on prior art FDCs involving similar drugs.
- Patent examination in China emphasizes novelty, inventive step, and industrial applicability; the unique ratios or formulation details are likely to meet these criteria if thoroughly documented.
Enforcement and Market Implication
- The patent provides market exclusivity for the claimed combination within China.
- Given the widespread use of pioglitazone and DPP-4 inhibitors globally, the patent covers a potentially lucrative segment in China.
- Enforcement may involve monitoring for FDCs with similar ratios or formulations by competitors, especially in the generic sector.
Strategic Considerations
- Partnerships with Chinese pharmaceutical manufacturers should be evaluated for licensing or joint development opportunities.
- Patent lifecycle expires approximately 20 years from filing (2019), around 2039, with potential extensions if supplementary protections are granted.
- Patent strength relies on the specificity of formulations; generic manufacturers could challenge based on prior art or obviousness.
Key Takeaways
- CN121401264 claims a specific fixed-dose combination of pioglitazone and DPP-4 inhibitors, focusing on formulation ratios.
- The patent fills a gap in China's patent landscape by asserting novelty through specific combinations and formulations.
- Existing patents cover similar drug combinations but differ in ratios, drug forms, or manufacturing methods.
- Patent enforcement can protect market share but may face challenges based on prior art and obviousness.
- Strategic licensing or partnership opportunities are available with this patent's scope.
FAQs
1. What is the main innovation claimed in CN121401264?
A fixed-dose combination of pioglitazone and DPP-4 inhibitors with specific ratios aimed at improved efficacy and stability.
2. How does this patent compare internationally?
It aligns with global trends in combination therapies for diabetes but emphasizes particular ratios and formulations unique to China.
3. Are similar patents filed elsewhere?
Yes, patents such as US8883530 cover similar drug combinations, differing mainly in drug ratios and delivery methods.
4. When does patent protection expire?
The patent filed in 2019 is expected to expire around 2039 unless extended or challenged.
5. What are potential patent challenges?
Obviousness based on prior combination patents, or invalidity claims citing prior art that discloses similar combinations.
References
- Chinese Patent CN121401264. (2021). Pharmacological composition for treating type 2 diabetes.
- US Patent US8883530. (2014). Combination of pioglitazone and sitagliptin.
- Chinese Patent CN110254321. (2018). Drug combination for type 2 diabetes.
- Chinese Patent CN108348765. (2017). Fixed-dose combination for diabetes treatment.
[1] Chinese Patent Office. (2021). CN121401264 patent database.
