Novo Nordisk seeks to block Mylan generic
Danish pharmaceutical company Novo Nordisk has sued Mylan in a US court over a proposed generic of diabetes drug Victoza (liraglutide).
In the suit, filed on Monday, August 20 at the US District Court for the District of Delaware, Novo Nordisk said that Mylan had illegally filed an abbreviated new drug application (ANDA) for the generic product with the US Food and Drug Administration.
According to Novo Nordisk, Mylan’s ANDA indicates that it intends to manufacture and sell a generic version of Victoza before the Danish company’s patent on the diabetes drug expires.
Victoza is a non-insulin product used to treat type 2 diabetes by lowering blood pressure. It is among Novo Nordisk’s highest-selling medicines.
In 2017, Novo Nordisk agreed to pay $58.7 million for failing to fully disclose that the drug was associated with a higher risk of thyroid cancer.
According to the US Department of Justice, the Danish company’s conduct “led some physicians to be unaware of the potential risks when prescribing Victoza”.
In the latest suit, Novo Nordisk asserted seven patents in total, covering a means of administering Victoza, as well as the drug itself.
The claimed inventions include a type of “needle mounting system and a method for mounting a needle assembly”.
The suit comes as Novo Nordisk faces legal troubles of its own in its native Denmark. Last Friday, August 16, the company confirmed that it was facing a securities lawsuit from shareholders. Novo Nordisk said that it “disagrees with the allegations and is prepared to defend the company in this matter”.
LSIPR has contacted Novo Nordisk and Mylan for comment.
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