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Generic Competition Intensifies as Nicergoline Breaks Monopoly Structure: The Rise of Samion Tablet

First national preparation for nicergoline Breaking of the “Samion Tablet” monopoly structure… Generic competition intensifies

Samion Tablet / Ildong Pharmaceutical

As the second trial of the lawsuit to cancel selective coverage for the brain function enhancer “choline alposcerate” is expected to be heard next month, “nicergoline”, which has had a restricted position in the pharmaceutical industry, again attracts l ‘Attention.

Choline alposcerate has been recognized as a dementia prevention agent or brain nutrient that should be taken by middle-aged people, and prescriptions have recently increased to the point that the market size has reached 500 billion won.

However, as politicians and the medical industry highlight cases of misuse and controversies over effectiveness, a clinical re-evaluation by the Ministry of Food and Drug Safety is currently underway.

In 2020, the Health Insurance Review and Evaluation Service decided to maintain health insurance coverage for choline alfoscerate only for the treatment of dementia and to apply selective coverage (80% out-of-pocket expenses) to efficacy and disparate effects from dementia, such as mild cognitive impairment, disability and emotional anxiety…

As a result, some pharmaceutical companies filed a lawsuit against the government to cancel the selective coverage of choline alposcerate, but they lost the case one after another in the first trial. The pharmaceutical companies, including Daewoong Bio, disobeyed the ruling in the first trial and immediately appealed and are expected to be sentenced next month.

Nicegolin Tablet / Hanmi Pharmaceutical

Meanwhile, preparations of nicergoline, another brain function improver, appear to fill the void left by choline alposcerate as the generic drug market opens up in earnest.

The first nicergoline drug in Korea was Samion Tablet, introduced by Pfizer’s Ildong Pharmaceutical and approved in December 1978, and enjoyed a long-term monopoly.

The monopoly structure was broken when Hanmi Pharmaceutical received product approval for “Nisegoline”, the first generic version of Samion Tablet, last year. Since then, many pharmaceutical companies have entered the generic competition and are trying to enter the nicergoline market.

According to the “List of Pharmaceutical Benefits and Table of Maximum Benefit Amount” announced by the Ministry of Health and Welfare on the 27th of last month, starting from the 1st of next month, ▲Alvogen Korea Geniser Tab. 30 mg ▲ Hana Pharmaceutical Sarrin Tab. 30 mg ▲ Hwanin Pharmaceutical Niseon Tab. 30mg will receive health insurance benefits.

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