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24 February 2022Big Pharma

AstraZeneca sues Taro in blood-thinning drug patent dispute

AstraZeneca has sued  Taro Pharmaceuticals in two US federal courts alleging that Taro’s planned generic blood-thinning treatment infringes a patent for its  Brilinta (ticagrelor) medication.

The tablets in 90mg and 60mg dosage strengths reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome or a history of myocardial infarction.

They also reduce the risk of stent thrombosis in patients with ACS, and a first MI or stroke in patients with coronary artery disease at high risk for such events.

The pharma company filed the  complaints in the districts of New Jersey and New York, on Tuesday, February 22.

The action stemmed from the Abbreviated New Drug Application (ANDA) (number 211498) filed by Taro with the US  Food and Drug Administration (FDA) for approval to market generic versions of AstraZeneca’s blockbuster product.

The pharma company argued that the Israel-based drugmaker had infringed by planning the release of its version before the expiration of AstraZeneca’s US patent, number 10,300,065,  which is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for Brilinta.

In May 2019, the US Patent and Trademark Office duly and legally issued the ’065 patent, entitled “Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction.”

In its notice Letter, Taro told AstraZeneca that its ANDA contained a “paragraph IV certification” asserting that the ’065 patent is invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale of Taro’s generic ticagrelor tablets.

AstraZeneca has countered that the claims of the ’065 patent are valid and enforceable and is seeking a judgment that Taro’s making, using, offering to sell the proposed generic ticagrelor tablets will infringe the ’065 patent.

It is also asking for a judicial order providing that the effective date of any approval of Taro’s ticagrelor ANDA shouldn’t be earlier than the latest expiration date of the ’065 patent, including any extensions and/or additional periods of exclusivity to which AstraZeneca is or becomes entitled to.

If Taro presses ahead with its plans, AstraZeneca has requested damages or other monetary relief to AstraZeneca if Taro engages in commercial manufacture, use, offers to sell, sale, or importation in or into the US of Taro’s generic.

This latest move comes after the company filed federal suits against  Torrent Pharmaceuticals and  Alembic Pharmaceuticals for their alleged infringement of the same patent.

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