【MHLW】280 generic products listed in National Health Insurance （NHI） Price List‐“Lyrica” as the first generic drug and other drugs from 22 companies joined the list

2020年12月29日 (火)

The Ministry of Health, Labor and Welfare (MHLW) will list 280 generic products in the price list of NHI today. The first generic listing is 123 items of three ingredients and 12 standards, including the pain treatment drug “Pregabalin” (original product: Lyrica=Pfizer) and so forth. Authorized Generic (A.G.), released as a generic product with the permission from the original product manufacturer to use the patent, is contained in 4 items of two ingredients, and four standards such as “Clopidogrel sulfate/aspirin” (ComPlavin Combination Tablets=Sanofi K.K.) and so forth, only if it is limited to the first generic drug. The rule of “0.4 multiplication” of the drug price of the original product for internal drugs if the new NHI price list requests exceed 10 items, will apply to 80 items of one ingredient and seven standards .

This time, 288 items requested for the NHI price list, however eight applications were withdrawn due to supply stability concerns. In the end, 280 items of 94 standards and 154 ingredients from 69 companies were listed.

Based on the listing status, there were 155 items of 44 ingredients and 73 standards for internal drugs, 42 items of 27 ingredients and 40 standards for injection drugs, and 83 items of 23 ingredients and 41 standards for external medicine. There was no listing of dental drugs.

The first generic products listed are 123 items of three ingredients and 12 standards such as the pain treatment drug “Pregabalin,” the Alzheimer’s disease treatment drug “Rivastigmine,” and the antiplatelet drug “Clopidogrel sulfate/aspirin.” There were 83 items of two ingredients and eight standards for internal medicine—also 40 items of one ingredient and four standards for external drugs.

Among these, A.G. which has the permission to use a patent from the original manufacturer contained two ingredients, “Pregabalin” and “Clopidogrel sulfate/aspirin,” planned to be released in advance as a generic product.

Teva Takeda Pharma had the largest number of listed items, including new alternatives such as changing to a generic name from the viewpoint of medical safety, with 16 items, followed by Nichi-Iko’s 14 items, Towa Pharmaceutical’s 11 items, each from Sawai Pharmaceutical and Kobayashi Kako, and eight items each from Daiichi Sankyo Espha, Teikoku Seiyaku, and Yoshindo.

The top companies in the number of listed items excluding alternative new items are Nichi-Iko’s 11 items, Sawai Pharmaceutical and Towa Pharmaceutical’s ten items, Daiichi Sankyo Espha and Yoshindo’s eight items, and Kyosomirai Pharma and Nipro’s seven products.

The largest number of items listed was 80 items from 22 companies for “Pregabalin” and 40 items from ten companies for “Rivastigmine.”

The rule of “0.4 multiplication” of the drug price of the original drug price internal drugs if the new NHI price list requests exceed ten items is applied to “Pregabalin”.