More generic 'Vimovo' drugs with naproxen+PPI enters the mkt

Four companies, including KyungDong Pharm, obtained reimbursement…will they overcome the market dominance of Hanmi-LG?

Product photo of the original drug

Generic drugs containing the same active ingredients as the 'Vimovo' (naproxen+esomeprazole magnesium trihydrate), a combination of an anti-inflammatory drug and an anti-ulcer agent, are set to be released.

 

A generic has not been approved since Chong Kun Dang's 'Naxen S Tab' was approved in 2024.

 

Considering the characteristics of a generic containing two types of active ingredients, proving a pharmaceutical equivalence test on each active ingredient may have been challenging.

 

Furthermore, analysis suggests new product entry to this market poses a challenge due to 'Naxozole,' a salt-changed product that was launched at a relatively lower price, with a strong presence.

 

According to the industry on June 27, four generic Vimovo drugs, including KyungDong Pharm's 'Nasopra Tab 500/20 mg,' will be listed with reimbursement next month.

 

KyungDong Pharm is the organizing company.

 

The company's Nasopra Tab 500/20 mg met two types of requirements.

 

Thus, the price was assessed at KRW 715, the same as the original Vimovo.

 

In contrast, the drug price of the generics meeting only one requirement was set as KRW 608.

 

These include Genuonesciences' 'Gemovo Tab 500/20 mg,' Mother's Pharmaceutical's 'Vimo M Tab.

 

500/20 mg,' and Dongkook Pharmaceutical's 'Exoraxen Tab 500/20 mg.' These drugs treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients at risk of gastric or duodenal ulcers associated with NSAIDs, such as naproxen, or in those who are not adequately treated with low-dose naproxen or other NSAIDs.

 

Joined later by four companies, products containing the same active ingredients as Vimovo have now increase from two to six.

 

Previously, LG Chem's 'Vimovo Tab 500/20 mg' and Chong Kun Dang's 'Naxen S Tab' were the only generics available.

 

Furthermore, Naxen S Tab has been on the market for over 10 years since its approval in 2014.

 

Even without re-examination periods or patent barriers, generic versions have not been made available, likely due to the significant difficulty of conducting bioequivalence tests for this combination therapies.

 

To prove bioequivalence for generic Vimovo drugs, it's necessary to compare the human absorption rates of each component, naproxen and esomeprazole.

 

This process is complex, and achieving favorable results is challenging.

 

Korean pharmaceutical companies have shifted their development efforts towards modified drugs that use a different salt of esomeprazole.

 

Currently, there are five such salt-changed products available, including Hanmi Pharm's 'Naxozole Tab.

 

500/20 mg.

 

Naxozole recorded KRW 25.8 billion in outpatient prescription sales last year, according to UBIST data, surpassing the original Vimovo (KRW 21.7 billion).

 

The issue, however, is that Naxozole is relatively low-priced, at KRW 445 per tablet, which is the cheapest among competing products.

 

Naxen S, a generic version of Vimovo, is relatively inexpensive at KRW 490 and recorded KRW 4.2 billion in outpatient prescription sales last year.

 

In contrast, these newly reimbursed generic drugs are priced KRW 100-200 higher than Naxen S, based on the estimation criteria.

 

Therefore, it's uncertain whether they will exhibit drug price competitiveness against Naxozole and Naxen S in the market.

 

However, an analysis suggests that if they enter the market with high CSO (Contract Sales Organization) fees based on their higher drug prices, they could increase their market share.

 

Amid other generic companies also preparing for market entry, attention is now focused on the market performance of the products from KyungDong Pharm and the other three companies that have recently obtained reimbursement.