Celltrion's 'Jimpentra' Secures U.S. Formulation Patent Registration... "Defense Against Biosimilar Entry"

Celltrion announced on the 11th that its autoimmune disease treatment new drug Jimpentra (the US brand name of RemsimaSC) completed formulation patent registration with the United States Patent and Trademark Office (USPTO) on the 9th (local time).

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Jimpentra is a unique subcutaneous injection formulation treatment containing infliximab, independently developed by Celltrion. Infliximab is one of the most widely used tumor necrosis factor (TNF)-alpha (α) inhibitors for treating autoimmune diseases such as inflammatory bowel disease. Until now, the product had only been available in intravenous injection form, but Celltrion succeeded in developing the subcutaneous injection formulation for the first time in the world. It has already been sold under the product name RemsimaSC in major global markets such as Europe, gaining recognition for its efficacy and convenience, and in October last year, it was approved as a new drug by the US Food and Drug Administration (FDA) and launched in the US last month.

The newly registered patent is a barrier patent that can defend against market entry of subcutaneous injection formulation infliximab biosimilars developed by competitors in the future. Celltrion secured exclusive rights for Jimpentra in the US market until the patent expiration in 2038. It is expected that with the registration of the already filed administration method patent, patent protection could extend up to 2040.

Through Jimpentra’s patent strategy, Celltrion plans to establish a solid position in the US market and generate stable mid- to long-term profits, considering that the new drug’s price is higher than that of biosimilars. Prior to this, Celltrion has secured formulation patents for RemsimaSC in major countries including Europe, Canada, as well as key Asian countries such as Korea, Japan, Australia, and Taiwan. As the importance of product protection in the market through patent registration is rising, the company intends to continue focusing on securing global patent rights. In particular, by securing multiple patent rights in the US, the world’s largest market, Celltrion aims to create a dense defensive barrier to block other companies’ market entry.

A Celltrion official said, “With the formulation patent registration of Jimpentra, we have strengthened not only our exclusive position in the US but also our global competitiveness,” adding, “As interest in Jimpentra and other subcutaneous injection formulation treatments rapidly expands due to their high treatment convenience, we will focus on our global patent strategy to solidify market dominance and achieve stable sales.”

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