Under the terms of this agreement, Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets (a generic version of IBRANCE), and thereafter, for the manufacturing and supply of the product. Zydus will be responsible for commercialization of the oncology product in the US.

Synthon was the first sole ANDA applicant for Palbociclib Tablets 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.

The total addressable market opportunity of Palbociclib Tablets in the US is approximately $3.1 billion as per the IQVIA MAT Nov. 2023.

Dr. Sharvil Patel, managing director of Zydus Lifesciences, said: “We are pleased to partner with Synthon for the commercialization of this important drug product. The partnership will bring access to a high unmet need therapy area for patients in the US. We are certain that by pooling our resources and knowledge, we will meet critical needs of patients and stakeholders.”

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company’s consolidated net profit surged 53.2% to Rs 800.7 crore on 9.1% increase in revenue from operations to Rs 4,368.8 crore in Q2 FY24 over Q2 FY23.

The scrip rose 0.59% to currently trade at Rs 713.05 on the BSE.