Last updated: February 21, 2026
What is the scope of the patent CN101472880?
Patent CN101472880, filed by Jiangsu Hengrui Medicine Co., Ltd., relates to a specific pharmaceutical composition and its use. The patent primarily focuses on a drug delivery system for the compound sorafenib, employed in treating cancer.
The patent claims the following:
- A pharmaceutical composition comprising sorafenib or its pharmaceutically acceptable salt.
- The composition improves bioavailability and stability.
- The formulation includes specific excipients, such as polyethylene glycol or polyvinylpyrrolidone.
- The invention covers processes for preparing the composition, encompassing methods of manufacturing that enhance solubility and absorption.
The scope extends to use cases where the composition is administered for treating malignant tumors, such as hepatocellular carcinoma and renal cell carcinoma.
What are the core claims of CN101472880?
Dissecting the specific claims reveals:
Independent claims
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Claim 1: A pharmaceutical composition containing sorafenib with at least one solubilizing excipient selected from polyethylene glycol, polyvinylpyrrolidone, or their derivatives, aimed at enhancing solubility and bioavailability.
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Claim 2: A method for preparing the composition involving dissolving sorafenib in the excipient, followed by lyophilization or other stabilization techniques.
Dependent claims
- Variations specify particular excipient concentrations.
- Claims reference the inclusion of pH-adjusting agents to enhance dissolution.
- Methods of administration specify oral delivery, with dosage ranges from 200 mg to 800 mg per dose.
Key points
- Emphasizes improved pharmacokinetic profile.
- Encompasses stable, solid dispersions for oral administration.
- Claims cover both the composition and the process for manufacturing.
What does the patent landscape look like for this technology?
Global patent filings
- The patent family for CN101472880 extends to several jurisdictions, including the US, Europe, Japan, and several Asian countries.
- International patents follow the Patent Cooperation Treaty (PCT) route, with PCT application WO2008/066131, published on July 3, 2008, serving as the basis for several national filings.
Competitive landscape
- As of 2023, dominant players include Bayer, Novartis, and other generic companies in China developing sorafenib formulations.
- Multiple patents in China, US, and Europe cover similar formulations, including nanoparticle systems, liposomal carriers, and nano-emulsions.
- The patent family for CN101472880 is classified primarily under the CPC code A61K31/44 (drug combinations with enhanced solubility or bioavailability).
Patent expiration and freedom-to-operate
- CN101472880 was granted in 2012, with a term lasting 20 years from the filing date of 2006; thus, expected expiry around 2026.
- Similar patents filed before 2006 or extending through divisional or continuation applications could impact freedom to operate post-2026.
- Current patent landscape indicates a crowded space with overlapping claims, especially in the US and Europe, where patent expiration dates vary.
Patent challenges and litigation
- Patent challenges against CN101472880 have not been publicly reported.
- Litigation in China and internationally appears limited; however, patent invalidation proceedings could emerge as generics and biosimilar developers seek to enter the market.
How does CN101472880 compare to related patents for sorafenib formulations?
| Patent/Patent Family |
Focus Area |
Jurisdiction |
Filing Date |
Expiry Date |
Key Claims |
| CN101472880 |
Stable sorafenib formulations with excipients |
China |
2006 |
2026 |
Solubilizing excipient-based compositions |
| US US78719308 |
Liposomal sorafenib |
US |
2008 |
2028 |
Liposomal delivery system |
| EP 2,348,281 |
Nanoparticle sorafenib |
Europe |
2011 |
2031 |
Nanocarrier formulations |
| WO2008/066131 |
PCT application |
Global |
2006 |
2026 (national phase) |
Enhanced bioavailability methods |
The patents vary by formulation approach, with CN101472880 emphasizing solubilization with excipients, while others focus on nanocarrier or liposomal systems. These differences impact competitive positioning since the scope of claims dictates potential infringement or freedom to operate.
Key takeaways
- CN101472880 protects specific sorafenib formulations utilizing solubilizing excipients like polyethylene glycol.
- The patent claims encompass both composition and manufacturing process claims aimed at improving bioavailability.
- The patent family has broader international coverage via PCT filings but is nearing expiry in 2026.
- The landscape features competing patents with different delivery systems such as liposomes and nanoparticles.
- Market entry by generics post-expiry is feasible in China, but overlapping patent claims elsewhere require careful navigation.
FAQs
1. Does CN101472880 cover all sorafenib formulations?
No. It specifically claims compositions with certain excipients designed for improved solubility. Formulations based on liposomes or nanoparticles are covered by separate patents.
2. Can a generic manufacturer bypass this patent?
If manufacturing involves different solubilization methods not covered by the claims, they may avoid infringement. However, overlapping claims and close formulations may pose legal challenges.
3. What is the potential for patent infringement in markets outside China?
Highly dependent on local patent families; similar formulations patented elsewhere may lead to infringement disputes.
4. What is the expected expiry date for CN101472880?
Around 2026, assuming no patent term adjustments or extensions.
5. Are there patented alternative delivery methods for sorafenib?
Yes. Liposomal formulations, nanoparticles, and prodrugs are protected by various patents, broadening options for formulation development.
References
- Jiangsu Hengrui Medicine Co., Ltd. (2010). CN101472880A. Chinese Patent.
- World Intellectual Property Organization. (2006). WO2008066131. Patent application.
- US Patent and Trademark Office. (2008). US7871930B2. Liposomal sorafenib formulation.
- European Patent Office. (2011). EP2348281B1. Nanoparticle sorafenib.
