(Health Korea News / Lee Chung-man) The offensive by generic companies against Yuhan Corporation’s gastritis treatment drug ‘Recomid SR Tab’ (ingredient name: rebamipide) is becoming increasingly fierce. ‘SR Tab’ is an abbreviation for ‘Sustained Release tablet’, meaning a drug (tablet) that is slowly released.
On the 18th, CMG Pharmaceutical received approval from the Ministry of Food and Drug Safety for the IND (Investigational New Drug) plan for ‘Remipide SR Tab’ (ingredient name: rebamipide), a generic product of ‘Recomid SR Tab’. The test will be conducted at Bumin Hospital to evaluate the bioequivalence of ‘Remipide SR Tab’ 150mg and ‘Recomid SR Tab’ on healthy adults.
‘Recomid extended-release tablet’ is an improved extended-release new drug of Otsuka Pharmaceutical’s gastritis treatment drug ‘Mucosta’ (ingredient name: rebamipide). ‘Mucosta’ is used to improve gastric mucosal lesions such as acute gastritis and acute exacerbation of chronic gastritis.
This drug has been used in the domestic market for a long time since its approval in 1991, and has proven its safety and effectiveness, establishing it as a key product of Otsuka Pharmaceutical. At one time, it had sales of close to 30 billion won, and when its patent expired in 2009, over 100 generic drugs were released.
However, because so many pharmaceutical companies have launched generic drugs, the market has reached saturation. Accordingly, Yuhan Corporation joined hands with GC녹십자, Daewoong Pharmaceutical, and Daewon Pharmaceutical to develop an improved new drug with the extended-release rebamipide ingredient, reducing the daily dosage from 3 to 2 tablets.
These pharmaceutical companies entered the market by obtaining product approval under the names of ‘Recomid extended-release tablet’ (Yuhan Corporation), ‘Mucotect extended-release tablet’ (GC Green Cross), ‘Mucotra extended-release tablet’ (Daewoong Pharmaceutical), and ‘Bidreva extended-release tablet’ (Daewon Pharmaceutical) in December 2020, respectively. The related patents will be held by Yuhan Corporation and its subsidiary, Addpharma. The patents are scheduled to expire on September 4, 2040.
The four generic products recorded a total of 15.2 billion won in outpatient prescription sales in their first year of launch, of which ‘Recomid extended-release tablets’ recorded the highest at 5.8 billion won. This was followed by ‘Mukotect extended-release tablets’ at 4 billion won, ‘Bidreva extended-release tablets’ at 2.9 billion won, and ‘Mucotra extended-release tablets’ at 2.4 billion won.
In particular, while the existing immediate-release rebamipide formulation market was already saturated and there was not much change in the prescription amount of the product, four pharmaceutical companies including Yuhan Corporation recorded remarkable growth in the rebamipide formulation market and greatly benefited from the sustained-release formulation.
Due to this, domestic pharmaceutical companies are turning their attention to Yuhan Corporation’s ‘Recomid Extended-Rang Tablet’, the original, and are aiming to enter the extended-release rebamipide formulation market.
In addition, the Pharmaceutical Benefits Evaluation Committee of the Health Insurance Review & Assessment Service recognized the appropriateness of reimbursement for the ingredient Rebamipide at the end of 2023, further stimulating the development of generic versions of ‘Recomid Extended-Range Tablets’ by late entrant pharmaceutical companies.
In fact, many pharmaceutical companies have filed a passive scope confirmation trial for the formulation patent of ‘Recomid SR’, and as of November 2023, 16 companies have successfully avoided the patent. (See related article below)
Generic companies are simultaneously applying for bioequivalence IND to the Ministry of Food and Drug Safety and are speeding up the acquisition of generic approval for ‘Recomid Extended Release Tablets’. This is interpreted as being because they can request a patent invalidation trial before the patent expires and obtain preferential sales rights if they receive product approval thereafter.
There are currently a total of 16 bioequivalence INDs for ‘Recomid SR’ approved by the Ministry of Food and Drug Safety. If we include trials conducted under the project name, the number is expected to be higher.
CMG Pharmaceutical, which received approval for the bioequivalence test this time, previously received approval for two bioequivalence tests to evaluate its generic ‘Remifid extended-release tablet’ in the post-meal and fasting states in June and July 2023.
The bioequivalence evaluated in the double fasting state is identical to the test design approved this time, and it is expected to increase the possibility of approval by the Ministry of Food and Drug Safety by more clearly proving the fasting state bioequivalence of the company’s ‘Remifid extended-release tablet’ and Yuhan-Yanghaeng’s ‘Recomid extended-release tablet’.
“The launch of generics is not necessarily detrimental to the original drug,” an industry insider said. “The more generics there are, the more valuable the original drug can be.”
Copyright © Health Korea News. Unauthorized reproduction and redistribution prohibited.
Source: www.hkn24.com
