Chong Kun Dang’s capsuled low-dose Xarelto generic approved

Hanmi and SK received preferential sales rights for 2.5 mg tablet starting from September

Chong Kun Dang generic in capsule form may be released on Oct. 4 next year when product patent expires

Xarelto tablet 2.5mg

Chong Kun Dang’s generic version of Bayer’s anticoagulant Xarelto (rivaroxaban) tablet was approved as a first capsule form in Korea.

 

The 2.5 mg low-dose capsule would be able to evade Hanmi Pharmaceutical and SK Chemical’s preferential sales rights on their generic products with the change in administration form.

 

On Apr.

 

9, Ministry of Food and Drug Safety (MFDS) has reported its clearance on ChongKunDang Rivaroxaban Capsule 2.5 mg.

 

The generic the same pharmaceutical substance rivaroxaban as Bayer’s Xarelto tablet, but it is in capsule form.

 

Chong Kun Dang’s generic is the first capsule out of the 22 generics approved with the same substance in Korea.

 

The Korean company has its reason why it changed the form.

 

SK Chemicals and Hanmi Pharmaceutical have already challenged the patent and respectively received the first approvals on their SK Rivaroxaban tablet 2.5 mg and Riroxban tablet 2.5 mg, along with the preferential sales rights.

 

SK Chemicals and Hanmi Pharmaceutical have challenged Xarelto’s pharmaceutical substance patent (expected to expire on Nov.

 

13, 2024) with low-dose form (2.5 mg) and won the generic market exclusive sales right (preferential sales right) for rivaroxaban.

 

The preferential sales right’s sales ban on other generics would last from Oct.

 

4, 2021, when Xarelto’s first-to-file (FTF) patent on the product and the use expires, to July 3, 2022.

 

Accordingly, generics sharing a same type of form and active ingredient with Hanmi Pharmaceutical and SK Chemicals’ generic would be ruled out from market release during the sales ban period.

 

But Chong Kun Dang’s capsule can avoid the sales ban with a different form of capsule.

 

Ultimately, the three Korean companies would be able to launch their generics all at the same time.

 

Besides Bayer with the original, Hanmi Pharmaceutical, SK Chemicals, Chong Kun Dang and Hanlim Pharm had their 2.5 mg low-dose rivaroxabans approved.

 

Currently, Hanlim Pharm is in process of patent challenge.

 

But its generic would be banned from the sales during the preferential sales rights period.

 

A study has confirmed 2.5 mg rivaroxaban, combined with Aspirin, reduces the risk of heart attack, ischemic stroke or cardiovascular death in patients either with coronary artery disease (CAD) or peripheral artery disease (PAD) relatively more than the Aspirin monotherapy.

 

Based on the findings, foreign academic societies recommend using Xarelto 2.5 mg plus Aspirin in patients with high-risk chronic CAD.

 

The demand for 2.5 mg dose is exists, but other follow-on drug makers, except for those with preferential sales rights, would be able to launch their products after Nov.

 

14, 2024, when the original’s patent expires.

 

UBIST reported the mega blockbuster drug Xarelto has made 46.2 billion won last year in outpatient prescription, which is why the industry is keeping their close eye on if Chong Kun Dang would get to successfully launch the capsule-form rivaroxaban dodging the preferential sales ban.