Pfizer takes legal action against Indian drugmakers over generic cancer drug

pharmafile | November 17, 2020 | News story | Manufacturing and Production  

Pfizer has filed a petition in a US court against Indian companies Dr Reddy’s Laboratories and Aurobindo Pharma that alleges the pair were planning to release generic versions of Ibrance before the expiration of Pfizer’s patent. 

Pfizer filed the possible patent infringement petition against both companies in the District Court for the District of Delaware. 

The company said: “In March 2019, several generic companies notified us that they had filed abbreviated new drug applications with the US Food and Drug Administration (FDA) seeking approval to market generic versions of Ibrance. The generic companies assert the invalidity and non-infringement of two compositions of matter patents and a method of patent covering palbociclib, each of which expires in 2023.”

Pfizer said in its petition that the Indian drugmakers had submitted abbreviated new drug applications to the FDA to engage in the commercial manufacturer, sale and importation of generic versions of Ibrance. Pfizer is seeking an injunction to stop the companies from creating their generic version. 

Ibrance (palbociclib) is used to treat breast cancer and works to stop the growth of cancer cells. It has generated nearly $5 billion in revenue, with $3.25 billion coming in 2019, according to a Pfizer report. 

Conor Kavanagh

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