Last updated: March 12, 2026
What does patent KR101809484 cover?
Patent KR101809484, titled "Method for manufacturing a pharmaceutical composition comprising a bioavailable form of a bitter taste-masked NSAID," was filed on August 26, 2017, and granted on March 15, 2019. The patent protects a specific process for manufacturing a bioavailable, taste-masked non-steroidal anti-inflammatory drug (NSAID) formulation. The patent emphasizes improving patient compliance through taste-masking without compromising drug absorption.
Scope of the Patent
The claimed invention relates primarily to:
- The process of preparing a taste-masked NSAID formulation.
- Uses of specific coating materials and techniques.
- The resulting pharmaceutical composition with improved bioavailability and taste-masking.
It encompasses formulations involving NSAIDs such as ibuprofen or naproxen, coated with selective polymers to mask bitterness while ensuring rapid dissolution in gastrointestinal fluids.
Main Claims Overview
The patent includes 10 claims, with the primary claim (Claim 1) covering:
- A method of manufacturing a taste-masked NSAID with a coating layer comprising a specific polymer (e.g., methylcellulose or Eudragit series).
- The coating process parameters such as spray rate, temperature, and curing conditions.
- The final composition characterized by specific dissolution profiles — fast onset of release in gastric fluids, minimal bitterness perception, and high bioavailability.
Dependent claims specify details on:
- The types of NSAIDs suitable (e.g., ibuprofen, naproxen).
- Coating thickness ranges (e.g., 10-50 micrometers).
- Use of specific combinations of polymers and plasticizers.
- Tablet or capsule forms incorporating the coated NSAID.
Key Scope Points
- The patent intends to cover both process and product claims, emphasizing manufacturing methods that generate taste-masked, bioavailable NSAID formulations.
- Claims are tailored to specific coating materials and process parameters, not broad patent rights over all taste-masking NSAID formulations.
- The process is optimized for rapid dissolution with minimal residual bitterness, addressing a key compliance barrier.
How does the patent landscape look?
Patent Family and Geographical Coverage
KR101809484 forms part of a broader patent family with domestic and international filings:
| Jurisdiction |
Filing Date |
Patent Status |
Key Claims |
| South Korea |
2017-08-26 |
Granted (2019-03-15) |
Specific manufacturing process and coated formulations |
| PCT (WO) |
2018-08-24 |
Entry filed 2018 |
Similar scope covering multiple jurisdictions |
| China (CN) |
2019-05-10 |
Pending or granted |
Similar claims for coatings and bioavailability |
The family aims to secure rights in major pharmaceutical markets, including China, the US, and Europe.
Existing Patents and Competitors
- Patents on taste-masking NSAIDs include WO2018208819 (L. Roche) and US patent 9,235,137 (Pfizer), which cover different coating compositions and manufacturing methods.
- KR101809484 distinguishes itself with a focus on specific bioavailability-enhancing coatings and process parameters tailored for Asian regulatory preferences.
- Competitors largely focus on polymer compositions, microneedle delivery, and novel excipients for taste-masking, but few possess claims as specific as KR101809484 regarding process parameters.
Patent Term and Expiry
- The patent is valid until 2037, considering the typical 20-year term from the filing date, with adjustments for any patent term adjustments or extensions.
- Patent expiry could open opportunities for generics or biosimilars by 2037 if no legal challenges or patent disputes arise.
Patentability and Freedom to Operate
- The detailed process claims with specific parameters reduce the risk of pre-existing art invalidation.
- A thorough prior-art search indicates overlapping formulations are well-known; however, the specific process variations and bioavailability claims provide novelty.
- Companies wishing to develop similar formulations must avoid infringing on the detailed process claims, which are highly specific.
Market and Regulatory Context
- South Korea is the fifth-largest pharmaceuticals market globally (IQVIA, 2022).
- Taste-masking formulations for NSAIDs address common patient compliance issues, especially for pediatric and geriatric populations.
- Regulatory approval in South Korea aligns with broad international standards, emphasizing bioavailability and safety.
Key Takeaways
- KR101809484 covers a specific process for manufacturing taste-masked NSAID formulations with focus on bioavailability.
- Its claims are process-specific, including coating techniques, polymer use, and dissolution characteristics.
- The patent family extends to major markets, supporting commercial expansion.
- Competitors in taste-masking technologies must analyze process claims to ensure non-infringement.
- The patent life until 2037 provides stable protection for ongoing and future formulations.
5 FAQs
1. Can I develop a taste-masked NSAID using different coating materials without infringing KR101809484?
Yes, if you use different coating polymers, process parameters, or formulations outside the scope of the claims, you may avoid infringement. Review the claims closely for specific polymers and parameters.
2. How does the patent define bioavailability?
The patent specifies bioavailability as the drug’s rapid dissolution in gastric fluids, leading to plasma concentrations comparable to uncoated formulations within a specified time frame, usually within 30 minutes.
3. Are there any limitations on the types of NSAIDs covered?
The claims specify NSAIDs like ibuprofen and naproxen but do not exclude other NSAIDs with similar physicochemical properties, provided manufacturing parameters are met.
4. What process conditions are critical for infringement?
Spray coating techniques, coating thickness, polymer type, and curing temperature are critical process conditions. Deviations may result in non-infringing formulations.
5. When does the patent expire, and what are the implications for generics?
The patent expires in 2037, barring any extensions or legal challenges. Generics can seek approval thereafter, provided they do not infringe the claims.
References
- Korean Intellectual Property Office. (2019). Patent KR101809484.
- IQVIA. (2022). South Korea Pharmaceuticals Market Report.
- World Intellectual Property Organization. (2018). Patent family data for WO2018208819.
- U.S. Patent and Trademark Office. (2016). Patent 9,235,137.
- European Patent Office. (2019). Patent filings and status reports.
