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ARTICLE · 31 JANUARY 2025

Amgen And Celltrion Settle Denosumab BPCIA Case

Goodwin Procter LLP
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On January 23, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement...

United StatesIntellectual Property
Darlene Staines
Darlene Staines

On January 23, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen and Celltrion resolving the BPCIA litigation regarding Celltrion's denosumab biosimilar, CT-P41. Pursuant to the agreement, Celltrion will be enjoined from making, using, selling, or importing CT-P41 into the U.S. market until June 1, 2025.

Celltrion submitted its BLA for CT-P41 to the FDA on November 30, 2023, referencing Amgen's PROLIA and XGEVA. Amgen filed suit against Celltrion on May 28, 2024, asserting 29 patents. In the Consent Judgment, Celltrion agreed that all 29 patents were valid, enforceable, and infringed.

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