AVNphotolab /
29 May 2018Americas

Pfizer takes Apotex to court over generic cancer drug

Pfizer has sued Canadian pharmaceutical company Apotex over its plan to make and sell a generic version of Pfizer’s Inlyta (axitinib) tablets.

Pfizer accused Apotex of infringing US patent number 8,791,140 in a filing at the US District Court for the District of Delaware on Friday, May 25.

Pfizer is the holder of New Drug Application number 202324, approved by the US Food and Drug Administration (FDA) for the treatment of advanced renal cell carcinoma after the failure of one systemic therapy.

Apotex allegedly submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to manufacture and sell a generic version of the cancer drug earlier this year, and informed Pfizer of the filing in April.

According to the lawsuit, Apotex’s notice letter purported to include an offer of confidential access to Pfizer to the ANDA.

“In an exchange of correspondence, counsel for defendants and counsel for Pfizer discussed the terms of Apotex’s offer of confidential access. The parties were unable to agree on terms under which Pfizer could review Apotex’s ANDA 211650, and defendants refused to produce other internal documents, samples, and data relevant to infringement,” said the claim.

Pfizer is seeking a judgment that Apotex has infringed the ‘140 patent and that the date of any FDA approval is not earlier than the expiration date of the patent. It is also seeking a preliminary and permanent injunction.

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