Reimbursed generics pour in with Xarelto's patent expiry

133 reimbursed Xarelto generics will be introduced to market next month

MOHW amends the drug reimbursement list ... Chong Kun Dang adds 1 item, Hanmi lists 2 new items

Prices of 11 products from 4 companies that are subject to premium pricing will be cut in April next year immeidately after term expiry

More than 100 reimbursed generics of Xarelto will be pouring into the market next month with the substance patent expiry of the novel oral anticoagulant (NOAC) Xarelto (rivaroxaban).

 

Among the drugs, products that are subject to premium pricing for being drugs from innovative pharmaceutical companies, etc.

 

are Chong Kun Dang’s Riroxia Tab.

 

15mg, and 20mg that was released earlier in May.

 

The two drugs will receive premium pricing for 7 months based on the release date of the 20mg strength.

 

According to industry sources on the 23rd, the Ministry of Health and Welfare is working to amend the ‘Drug reimbursement list and reimbursement ceiling price table’ to include such changes.

 

The changes will be effective from October 1st.

 

First, the price of Korea Prime Pharm’s Xaito Tab.

 

10mg has been set at 85% of the highest price of same ingredient drugs that are already listed as it met only one of the two standards set for pricing of generic drugs, and only one other same ingredient drug is currently listed and priced at 53.55% of the ceiling price of same ingredient drugs.

 

Twelve products will be listed at the same price as the highest price set for same ingredient drugs, 6 of which are rivaroxaban products.

 

Sixty-eight products will be listed at 85% of the highest price of already listed same ingredient drugs.

 

Among these, 60 products, including Han Poong’s Rivarell tab.

 

15mg, Boryung Biopharma’s Xarox tab.

 

15mg, Daewoong Bio’s Varelto tab.

 

15mg and 20mg, are rivaroxaban products.

 

Also, the price of 32 products was set lower than the ceiling price of its higher strength product that was filed for listing at the same time.

 

Such drugs include Daewoong Bio’s Varelto tab.

 

10mg, GC Pharm’s Neoroxaban tab.

 

10mg, Yuhan Phram’s Yuhan Rivaroxaban tab.

 

10mg, Yuyu Pharm’s Yuvaro tab.

 

10mg, Dong Wha Pharm’s Rivacor tab.

 

10mg, Aju Pharm’s Zatol tab.

 

10mg, Kolmar Pharma’s Newroxban tab.

 

10mg, and Whanin Pharm’s Jaroban tab.

 

10mg.

 

Also, a new 10mg strength product of Chong Kun Dang’s Riroxia tab.

 

that was already released in May will be newly listed.

 

The drug’s price had been set at a price lower than the ceiling price of its already listed higher strength product.

 

The government sets the ceiling price of lower strength products at a lower price than the ceiling price set for its higher strength counterpart when a higher strength drug with the same company, route of administration, ingredient, and formulation is already listed.

 

Therefore, Chong Kun Dang’s Riroxia tab.

 

10mg’s price was set at ₩1,312 per tablet.

 

Thirty-four products were set at the expected sales price.

 

The government allows a drug’s price to be set at the expected sales price submitted by the manufactuer·congisnged manufacturer·importer applicant when the price is lower than the price set according to standards.

 

Drugs that will be listed at the expected price are Boryung Biopharma’s Xarox tab.

 

10mg, Yooyoung Pharm’s Yooroxaban tab.10mg, Yungjin Pharm’s Xarex tab.

 

10mg, Samjin Pharm’s Rivoxaban Tab.

 

10mg, Hanmi Pharm’s Riroxban tab.

 

10mg, GC Pharm’s Neoroxaban tab.

 

15mg, Yuhan Pharm’s Yuhan Rivaroxaban Tab.

 

15mg, and JW Pharmaceutical’s Livalozet tab., etc.

 

Meanwhile, 11 rivaroxaban products from 4 companies will be listed with a premium.

 

The premium will expire in 7 months, on April 30th, 2022.

 

The government allows premium pricing for one year from the first generic was listed for some drugs.

 

For innovative pharmaceutical companies, the premium is set at 68% of the original drug price in the first year, then subsequently lowered to 53.55% after the term is terminated.

 

Products that benefit from this premium pricing are Chong Kun Dang’s Riroxia Tab 15mg and 20mg that was released first among generics in May.

 

As the premium pricing period is set based on the 20mg strength drug, the premium will be in effect for only 7 more months.