Use patent of Xarelto 2.5mg listed late

Hanmi and SK Chemicals acquire generic exclusivity to exercise from October next year

Use patent expires on June 7, 2022

Xarelto 2.5mg

Although Hanmi and SK Chemicals acquired market monopoly rights as a follow-up drug to the anticoagulant drug (NOAC), Xarelto 2.5mg (Rivaroxaban), it may not exercise its right.

 

This is because the use patent for Xarelto 2.5mg has been listed in the MFDS after the acquisition of the rights of both companies.

 

According to the MFDS, Hanmi and SK Chemicals obtained generic exclusivity right on July 5, 2016, with Riroxiban 2.5mg and Rivaroxaban 2.5mg, respectively.

 

The generic exclusivity period is from October 4, 2021 to July 3, 2022, when the material patent ends.

 

Both companies succeeded in evading the patent for Xarelto 2.5mg, and were granted the right to generic exclusivity through the first application for permission.

 

At the time, only the composition patent and the material patent were registered in the MFDS.

 

Accordingly, the two companies that avoided the composition patent exercised the right to generic exclusivity after the termination of the material patent.

 

However, in September of last year, Bayer Korea registered a use patent of Xarelto 2.5mg.

 

The application patent expires on June 7, 2022.

 

There is only a way to invalidate the patent in order for Hanmi and SK Chemical to release the patent normally during the copyright period, avoiding patent infringement.

 

It should be launched from June 8, 2022, when the patent ends.

 

The fact that the right to terminate the copyright was July 3, 2022.

 

This use patent contains the contents of the use as a drug for the prevention or treatment of thromboembolic disorders.

 

Xarelto 2.5mg has recently changed its efficacy and effectiveness.

 

At the time of the first item approval ▲Reduced risk of stroke and systemic embolism in patients with non-valve atrial fibrillation ▲Treatment of cardiac venous thrombosis and pulmonary embolism ▲Reduced risk of recurrence of cardiac venous thrombosis and pulmonary embolism ▲co-administered with acetylsalicylic acid (ASA) alone or with ASA plus Clopidogrel or Ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.

 

Recently, Xarelto, ▲ co-administered with acetylsalicylic acid (ASA) alone or with ASA plus Clopidogrel or Ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers, ▲co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.·Changed to effect.

 

Hanmi and SK Chemicals' generic exclusivity items were replaced with the same indications.

 

All of the altered indications are known to be related to the use patent.

 

Recently, Xarelto 2.5mg has been shown to reduce the risk of death from stroke, myocardial infarction and cardiovascular disease in adult patients with coronary artery disease or symptomatic peripheral arterial disease when used in combination with ASA.

 

Based on this, a recent overseas conference recommends a combination therapy of Xarelto 2.5mg-ASA for high-risk chronic coronary syndrome patients.

 

It is expected to boost the market preemption effect if the generic exclusivity is released earlier than the competitor based on the monopoly.

 

It is noteworthy how Hanmi and SK Chemicals will respond to lately registered patents.