Zydus Lifesciences’ wholly owned subsidiary, Zydus Worldwide DMCC, has entered into an exclusive licensing and supply agreement with Synthon BV for Palbociclib Tablets (a generic version of IBRANCE) for the US market.
Under the terms of this agreement, Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets, and thereafter, for the manufacturing and supply of the product. Zydus will be responsible for commercialisation of the oncology product in the US. Synthon was the first sole ANDA applicant for Palbociclib Tablets, 75 mg, 100 mg, and 125 mg, with a paragraph IV certification and therefore may be eligible for 180 days of generic drug exclusivity for all three strengths.
IBRANCE is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
- an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or
- fulvestrant in patients with disease progression following endocrine therapy.
The total addressable market opportunity of Palbociclib Tablets in the US is approximately $3.1 billion as per the IQVIA MAT Nov 2023.