It does not affect sales of Rivaroxaban 2.5mg

Hanmi said

There is little possibility of legal disputes ahead of the launch of Rivaroxaban 2.5mg

completed certification of contents

Xarelto 2.5mg

Hanmi dismissed the possibility of legal disputes over the patent registration of the original company ahead of the launch of Xarelto's generic.

 

The company said that the scope of validity of patents registered late does not affect Hanmi's new drug to be released.

 

In addition, Hanmi emphasizes that it did not take issue when it sent certification of contents to Bayer, the original company.

 

According to the pharmaceutical industry on the 29th, Hanmi is planning to release Riroxban, Xarelto's generic, on the 4th of next month.

 

133 items from up to 66 companies, including Hanmi, will be released simultaneously after the expiration of Xarelto's patents.

 

Expected items to be released are Rivaroxaban 10mg and Rivaroxaban 15mg.

 

On top of that, Hanmi's Riroxban 2.5mg is the only one to release.

 

This is because Hanmi succeeded in overcoming the composition patent registered exclusively in Rivaroxaban 2.5mg, and first of all, it received generic for exclusivity.

 

In the case of Rivaroxaban 2.5 mg, there may be legal disputes with the original company.

 

This is because Bayer registered a patent for use of Xarelto 2.5mg in September 2019, more than two years after obtaining generic for exclusivity.

 

The patent expires in June next year.

 

Regarding Bayer's registration, the pharmaceutical industry said it was aimed at hindering the early launch of generic.

 

In addition, the pharmaceutical industry predicted that if Hanmi pushes ahead with the sale of Riroxban 2.5mg, it will lead to a legal dispute between the two companies in the future.

 

Hanmi said, "There will be no impact on the launch of the Riroxban 2.5mg product." This is because the scope of validity of the registered patent is different from that of Hanmi's Riroxban 2.5mg.

 

According to the Korean Intellectual Property Office, the patent registered by Bayer is about "Oxazolidinone for combination therapy." Specifically, it explains, "It relates to a composite agent of Oxazolidinone and other active ingredients, the preparation method and use of the composite agent as a drug, and in particular, its use as a drug for the prevention and treatment of thromboembolic disorders." In other words, if it is a "combination drug" with Xarelto 2.5mg added with other ingredients, Aspirin is likely to be added as another active ingredient if it is recognized as a patent for use.

 

Bayer is said to have tried to register a combination therapy with other ingredients as a patent as a single drug.

 

Bayer did not release domestic combination drug and only patents are listed.

 

Hanmi said that Riroxban 2.5mg is not a combination type, so it is not a problem.

 

An official from Hanmi said, "Actually, the use of Rivaroxaban 2.5mg is limited to combination drugs, so it does not affect the single drug Riroxban 2.5mg.

 

There will be no problem with the launch of Riroxban 2.5mg."