lucarista /
2 June 2015Americas

Novartis sues Apotex at New Jersey court to protect Zometa

Novartis has sued Apotex at the US District Court for the District of New Jersey to protect its drug Zometa (zoledronic acid) from generic competition.

Zometa is an injection used to reduce and delay complications caused by certain cancers that have spread to the bone.

It is available in two dosage strengths: a 4mg/100ml ready to use bottle and a 4mg/5ml concentrate.

Zometa is covered by Novartis’s US patent 8,324,189, which expires in May 2025.

In April, Apotex notified Novartis that it had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to make and sell a generic version of Zometa before the ’189 patent expires.

It sought to make 4mg/100ml vials of zoledronic acid for intravenous infusion.

In the notification letter to Novartis, Apotex said that its ANDA included a paragraph IV certification that alleged that the ’189 patent is invalid, unenforceable, and would not be infringed by the Zometa generic.

Novartis has filed several other patent infringement lawsuits at the same court alleging infringement of the same patent.

It has asked the court for a judgment that its patent is valid and enforceable, that it has been infringed by Apotex’s ANDA filing, and that it would be infringed by the proposed Zometa generic.

Novartis has also asked the FDA to not approve the generic Zometa product until after the ’189 patent expires and for a permanent injunction stopping Apotex from marketing its proposed product until after the Novartis patent expires.

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