Ibrance clocked nearly USD five billion revenues globally including USD 3.25 billion in the USA in 2019, according to Pfizers 2019 annual report.
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 composition of matter patents and a method of use patent covering palbociclib, each of which expire in 2023, according to the annual report.
Pfizerin its petition stated that the Indian drug makers had submitted abbreviated new drug application(ANDA) to the USFDA 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 730patent.
Pfizer sought among others apreliminary 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.
UnderParagraph IVPatentCertifications, a company can seek FDA approval to market a generic drug before the expiration ofpatentsrelated to the branded medicine that the pharma company seeks to copy.
Acity-based pharmaceutical company senior official said patentlitigationcases are not uncommon for generic drug makers in the USand thelawsuit will not have any implications on the performance of the company.
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