(Health Korea News / Lee Chung-man) As the hair loss treatment market grows rapidly, the generic market for GSK’s ‘Avodart’ (ingredient name: Dutasteride) is once again in turmoil. With over 100 generics already released, low-dose products are receiving approval from the Ministry of Food and Drug Safety one after another.
On the 25th, the Ministry of Food and Drug Safety approved four generic versions of ‘Avodart’ as prescription drugs. The target indications are all for male pattern baldness treatment in adult males (18-50 years old).
The products approved on this day are ▲Kyungdong Pharmaceutical’s ‘Dubalkan tablet’ 0.2mg ▲Yuhan Corporation’s ‘Movana tablet’ 0.2mg ▲Daewoong Pharmaceutical’s ‘Dutarimo tablet’ 0.2mg ▲Handok’s ‘Modustar tablet’ 0.2mg.
The original drug, ‘Avodart’, is a drug that reduces DHT by inhibiting both types 1 and 2 of 5-alpha reductase, which convert testosterone into DHT (dihydrotestosterone).
DHT is a hormone that plays an important role in the onset and progression of benign prostatic hyperplasia as the main cause of prostate growth. It is also a major cause of male pattern baldness because type 1 5-alpha reductase is mainly present in the scalp. Therefore, ‘Avodart’ can be used for both benign prostatic hyperplasia and male pattern baldness.
Since receiving approval for male pattern baldness treatment from the Ministry of Food and Drug Safety in 2009, ‘Avodart’ has established itself as a treatment for hair loss, not for benign prostatic hyperplasia. It is one of the two major drugs in the hair loss treatment market, along with ‘Propecia’ (ingredient name: finasteride) from Organon Korea.
In particular, this drug has surpassed the existing powerhouse, ‘Propecia’, and has taken the top spot in the industry since 2021. According to IQVIA, in 2023, ‘Avodart’ had sales of 43.6 billion won, and ‘Propecia’ had sales of 39.6 billion won.
The reason for the rapid increase in sales of ‘Avodart’ is its price competitiveness. ‘Avodart’ was supplied at around 1,300 won per tablet, but since 2017, it has been supplied at around 700 won, while ‘Propecia’ is supplied at 1,590 won per tablet, which is twice the price of ‘Avodart’.
As a result, since the patent for ‘Avodart’ expired in 2016, domestic generic drug companies have rushed to develop generic drugs one after another to attack the market that ‘Avodart’ had occupied. Currently, there are a total of 114 dutasteride preparations approved by the Ministry of Food and Drug Safety.
The generic version of ‘Avodart’ has been in fierce competition, with 99 generics continuously receiving approval by 2020. However, since most companies have already participated in the generic competition of ‘Avodart’, news of generic approval of ‘Avodart’ has been rare since 2021. In 2021, 2022, and 2023, only two generics were approved each.
However, as the number of patients with hair loss in Korea has been increasing, especially in the younger generation of 2030, the competition for generic versions of Avodart is heating up again. Reflecting this, there are already eight generic versions of Avodart approved in 2024.
The four generics approved this time are all characterized by a 0.2 mg dose. Dutasteride preparations are usually administered in a 0.5 mg dose, but starting with a lower dose of 0.2 mg is expected to reduce the possibility of side effects such as erectile dysfunction.
Meanwhile, the four generics approved on this day are twin generics of UN Life Science’s ‘Abopecia Tablets’, and five items are manufactured at UN Life Science’s first plant.
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Source: www.hkn24.com
