China’s Hainan Shuangcheng Pharmaceutical Co., Ltd (SHE: 002693) has announced a Paragraph IV patent declaration in relation to the Abbreviated New Drug Application (ANDA) for its Paclitaxel, albumin-bound. This declaration indicates that Shuangcheng believes its drug does not infringe on the rights of Bristol-Myers Squibb’s (BMS, NYSE: BMY) originator drug Abraxane, or that the originator’s patent is invalid.
Drug Profile and Benefits
Paclitaxel, albumin-bound is a nanoparticle formulation of paclitaxel with albumin. Compared to other paclitaxel drugs, the cytotoxic side effects of this formulation are significantly reduced, allowing for higher doses and enhanced anti-tumor effects due to albumin-coated nanoparticles. Additionally, the drug can accumulate in tumors, release to tumor cells in a targeted manner, and further improve the efficacy of the drug.
Regulatory and Market Context
Shuangcheng Pharma made the ANDA filing in the US in March 2022, where the originator was approved under the trade name Abraxane in January 2005. The drug is reportedly under patent protection until July 12, 2034, and is also available on the market in China. The Paragraph IV declaration marks a significant step in Shuangcheng’s efforts to bring its version of Paclitaxel, albumin-bound to the US market.-Fineline Info & Tech
