Pfizer has filed a petition in a US court against Aurobindo Pharma and Dr Reddy’s Laboratories alleging that the Indian drugmakers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance (palbociclib) before expiration of its patent.
The US-based multinational pharmaceutical company filed the possible patent infringement cases against Aurobindo Pharma in Delaware and Dr Reddy’s in New Jersey district courts.
Palbociclib is used to treat a certain type of breast cancer and works by slowing or stopping the growth of cancer cells.
Ibrance clocked nearly $5 billion revenues globally, including $3.25 billion in the USA in 2019, according to Pfizer’s 2019 annual report.
Pfizer in its petition stated that the Indian drug makers had submitted abbreviated new drug application (ANDA) to the FDA seeking approval to engage in commercial manufacture, sale and importation of the intended generic drugs of ibrance capsules, 75 mg, 100 mg, and 125 mg prior to the expiration of the 730 patent.
Pfizer sought among others a preliminary and permanent injunction enjoining Aurobindo and DRL, from commercial manufacture, use, sale, offer for sale, or importation of the ANDA products, or any other drug product covered by 730 patent into the US, prior to expiration of that patent, including any extensions and additional period of exclusivity.
Under Paragraph IV Patent Certifications, a company can seek FDA approval to market a generic drug before the expiration of patents related to the branded medicine that the pharma company seeks to copy.
A pharmaceutical company senior official said patent litigation cases are not uncommon for generic drug makers in the US and the lawsuit will not have any implications on the performance of the company.