Medicure and Nexus agree Aggrastat generic licence

US cardiovascular therapies company Medicure has settled a patent infringement dispute with rival Nexus Pharmaceuticals.

The parties have agreed a licence agreement that will allow Nexus to launch generic versions of Medicure’s Aggrastat (tirofiban hydrochloride).

Nexus is expected to launch its 5mg tirofiban hydrochloride product on November 1, 2022, and a 12.5mg strength product on January 1, 2023.

The dispute arose after Nexus filed an abbreviated new drug application (ANDA) for a generic Aggrastat product at the US Food and Drug Administration (FDA).

Medicure sued Nexus at the US District Court for the Northern District of Illinois, accusing it of infringing Medicure’s patent covering Aggrastat (US number 6,770,660), which is set to expire in May 2023.

According to a Medicure announcement, Nexus acknowledged as part of the deal that the ‘660 patent is valid, enforceable and infringed. The remaining terms of the settlement were not publicly disclosed.

Aggrastat is a type of therapy known as a platelet aggregation inhibitor, which is designed to prevent thrombotic cardiovascular events in patients with non-ST elevation acute coronary syndrome.

"We are pleased that we were able to settle this litigation in a cost-effective manner while protecting our Aggrastat brand and its IP,” said Medicure CEO Albert Friesen.

Aggrastat is Medicure’s flagship product, alongside Zypitamag (pitavastatin), which is used to manage cholesterol levels.

The company has actively defended the patent in US courts in recent years. In November 2018, Medicure sued Gland Pharma in New Jersey for infringing the ‘660 patent through an ANDA.

The parties reached a settlement last August, with Gland also recognising the patent as valid, enforceable, and infringed.

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