Generic for Xarelto is about to be released.

It can be licensed and released, but there is a possibility of legal dispute

Bayer's new oral anticoagulant (NOAC) Xarelto (Rivaroxaban)' generic is imminent to be released.

 

In particular, Hanmi, which received generic exclusivity, plans to release Xarelto 2.5mg exclusively, and Hanmi has a patent dispute with Bayer, drawing keen attention to the future response of the two companies.

 

According to the pharmaceutical industry on the 24th, the Xarelto material patent will expire on the 3rd of next month.

 

Generic for Xarelto will be released after the 4th of next month.

 

In the case of the rest of the patents, Generic companies have succeeded through a Supreme Court ruling late last year.

 

133 generics for Xarelto are expected to be listed as starting next month.

 

A total of 66 generic companies are expected to release generics for Xarelto 10mg and 15mg products, respectively.

 

Hanmi's Riroxban 2.5mg was the only one to succeed in registering benefit.

 

Hanmi is expected to release Riroxban 2.5 mg at the same time along with Riroxban 10mg and Riroxban 15mg.

 

◆ Bayer and Hanmi have registered their patents for use after obtaining generic for exclusivity In the case of Riroxban 2.5mg products, patent disputes still remain.

 

This is because Bayer belatedly registered a patent for use in Riroxban 2.5mg after acquiring Hanmi's generic exclusivity.

 

Hanmi and SK Chemicals challenged patent for Xarelto 2.5mg in March 2015.

 

In November of that year, the two companies won the first trial.

 

Then, as the two companies applied for permission for the first time, in July 2016, the two companies succeeded in obtaining generic for exclusivity.

 

However, in September 2019, Bayer Xarelto 2.5 mg newly registered a patent for use.

 

The patent expires in June next year, more than two years after acquiring generic for exclusivity.

 

Since the new registration of the patent for use, the indication of Xarelto 2.5mg has also changed.

 

Initially, Xarelto monotherapy was approved for the purpose of "reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation."However, after the registration of the patent for use, the combination therapy with Aspirin changed to "reduction of the incidence of atherosclerotic events such as myocardial infarction and stroke." ◆Will legal disputes continue?

 

Riroxban's sales impact will be minimal The pharmaceutical industry predicts that it will lead to legal disputes between Bayer and Hanmi.

 

Some predict that even if the two companies have legal disputes, sales of Riroxban 2.5mg will not be significantly disrupted.

 

An official from the pharmaceutical industry said, "There was no problem with the approval of Riroxban 2.5mg after patent avoidance." However, if it is actually sold, there is a possibility that Bayer will raise the issue in the future, he said.

 

◆After the 4th of next month, it is predicted that generics for Xarelto such as Riloxvan will be released