Zydus Lifesciences Ltd. has announced that its wholly-owned subsidiary, has entered into an exclusive licensing and supply agreement with Synthon for Palbociclib Tablets for the US market, it said in an exchange filing.
Since Synthon was the first sole Abbreviated New Drug Application (ANDA) applicant for the Palbociclib Tablets 75 mg, 100 mg, and 125 mg, with a paragraph IV certification, it will therefore, may be eligible for 180 days of generic drug exclusivity for all three strengths.
Under the Paragraph IV certification, a company can seek approval from the USFDA to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy.
IBRANCE is a kinase inhibitor indicated for the treatment of adult patients with metastatic breast cancer.
As per this agreement, Synthon will be responsible for obtaining the US regulatory approval for the Palbociclib tablets and thereafter for the manufacturing and supply of the product. Zydus Life, on its part will be responsible for commercialisation for the oncology products in the US.
"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,” said Sharvil Patel, MD of Zydus Lifesciences.
As per the IQVIA MAT data dating back to November 2023, the total addressable market opportunity of Palbociclib tablets in the US is approximately $3.1 billion.
Shares of Zydus Life ended flat on Thursday at ₹710.4. The stock has risen 61% over the last 12 months.
