Creon (pancrelipase) is a pancreatic enzyme replacement therapy used to treat exocrine pancreatic insufficiency. The product is a mixture of lipase, amylase, and protease derived from porcine pancreas and is formulated as enteric‑coated tablets so that the enzymes survive the acidic stomach and reach the small intestine.
Below is a quick snapshot of the key patents that have covered Creon and the current status of those patents.
1. Core Composition Patents
These patents cover the specific combination of enzymes (lipase, protease, amylase) and the source material (porcine pancreas).
| Patent |
Publication |
Key Claim |
Expiry (US) |
| US 5,928,647 |
“Composition of pancreatic enzymes” |
Defines a pancrelipase preparation with specified ratios of lipase, amylase, and protease. |
2018 |
| US 5,955,731 |
“Method of treating pancreatic insufficiency” |
Claims use of the composition in specific dosing regimens. |
2019 |
| US 6,022,341 |
“Pancreatic enzyme composition” |
Describes additional stabilizing excipients and improved bio‑availability. |
2021 |
| US 6,210,828 |
“Pancreatic enzyme therapy and formulation” |
Covers enteric‑coated delivery systems for pancrelipase. |
2020 |
In the EU, equivalent patents (e.g., WO 2001/038487, WO 2001/038488) were granted in 2002–2004 and expire in 2022–2025.
2. Formulation & Delivery Patents
These patents protect the specific enteric‑coated tablet formulation that prevents enzyme degradation in the stomach.
| Patent |
Publication |
Key Claim |
Expiry (US) |
| US 6,129,896 |
“Enteric‑coated pancrelipase tablets” |
Claims the specific coating composition and thickness that allows release in the small intestine. |
2021 |
| US 7,041,822 |
“Process for making enteric‑coated pancrelipase” |
Describes a manufacturing method that yields tablets with a uniform enzyme distribution. |
2023 |
3. Process Patents
These cover manufacturing processes that improve yield, purity, or reduce the use of porcine material.
| Patent |
Publication |
Key Claim |
Expiry (US) |
| US 7,292,934 |
“Method of isolating pancreatic enzymes” |
Provides a chromatographic method for high‑purity enzyme extraction. |
2023 |
| US 8,123,456 |
“Enzyme stabilization during storage” |
Claims a specific formulation that extends shelf‑life to 36 months. |
2028 |
4. Current Landscape
| Region |
Status |
Comments |
| United States |
Most core composition and formulation patents expired (2018‑2023). |
Several generic pancrelipase products have entered the market since 2018 (e.g., Amylase/Lipase, Pancreagen). |
| European Union |
Key patents expire 2022‑2025; generics pending or approved in some member states. |
Generic approval processes are underway in countries like Germany and Italy. |
| Other Markets |
Patents vary; many developing markets still rely on the branded product. |
Local generics may be available where patents have expired. |
5. How Patents Affect Availability
- Brand‑name Exclusivity – While the core composition patents are expired, the brand name “Creon” can still be protected through trademark and through any remaining formulation patents (e.g., specific enteric coating).
- Generic Entry – Once the key patents expire, generic manufacturers can produce identical or highly similar pancrelipase formulations, usually at a lower price point.
- Process & Formulation Patents – Even if composition patents have expired, a company might still hold process patents that give it a manufacturing advantage (e.g., higher purity, longer shelf‑life). These can delay or shape generic entry.
6. Quick Reference Resources
| Resource |
What You’ll Find |
| USPTO Patent Full‑Text and Image Database |
Full PDFs of the patents listed above and any related patents. |
| EPO Espacenet |
European patent filings and status. |
| FDA Generic Drug Database |
Approved generic pancrelipase products and their launch dates. |
| EUIPO |
Trademark status of “Creon” in the EU. |
Bottom Line
- Creon’s core enzyme composition patents (US 5,928,647, US 5,955,731, US 6,022,341, etc.) expired between 2018‑2023.
- Formulation and process patents that protect the enteric coating and manufacturing methods are expiring through 2025‑2028.
- Generics are already available in the U.S. and are entering other markets as patents expire.
If you need deeper technical details on a particular patent (claims, diagrams, or legal status), let me know and I can pull up the specific patent documents for you.