World news – US – Pfizer files patent infringement petition in US court against Aurobindo and Dr. Reddy – Express Pharma

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Pfizer and its group companies filed a petition in US court against Aurobindo Pharma and Dr Reddy Laboratories claiming that Indian pharmaceutical companies were separately planning to come out with generic versions of the cancer drug Ibrance (palbociclib) before its patent expired.

Pfizer filed a potential patent infringement petition against both companies in the U.S. District Court for the Delaware County on two charges last week.. Palbociclib is used to treat a certain type of breast cancer and it works by slowing or stopping the growth of cancer cells. Ibrance has recorded approximately $ 5 billion globally including $ 3. 25 billion in the United States in 2019, according to Pfizer’s 2019 Annual Report. Public companies assert the invalidity and non-infringement of two patents for the substance and the method for using a patent covering palbociclib, each of which expires in 2023, according to the annual report. Pfizer stated in its petition that Indian companies have submitted a new abbreviated drug application (ANDA) to the United States Food and Drug Administration (USFDA) to obtain approval to engage in the commercial manufacture, sale and import of the intended generic drugs ibrance capsules, 75 mg, 100 mg, 125 mg prior to Patent 730 has expired.

Pfizer has sought, among other things, a preliminary and permanent injunction ruling Aurobindo and DRL, of the commercial manufacture, use, sale, offering for sale or import of ANDA products or any other 730 patent medicinal product to the United States, This patent has already expired, including any additional extensions and exclusive period. Under the fourth paragraph of patent certificates, a company can seek approval from the Food and Drug Administration to market a generic drug before the patents on the branded drugs that the drug company seek to copy expire.

A senior official at a city-based pharmaceutical company said that patent litigation cases are not uncommon for manufacturers of generic drugs in the United States and the lawsuit will not have any effects on the company’s performance..

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World News – US – Pfizer files patent infringement petition in US court against Aurobindo, Dr. Reddy – Express Pharma

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