Local pharmaceutical companies are preparing to release generic copies of Avodart (dutasteride), a treatment for enlarged prostate and hair loss, with reduced side effects.
The Ministry of Food and Drug Safety recently approved JW Pharmaceutical’s Jdart Tab., Dong-A ST’s Dutavan Plus Tab., Daehan New Pharm’s NPdart Tab., and JW Shinyak’s Neodart Tab.
|JW Pharmaceutical’s dutasteride tablets (JW Pharmaceutical)|
These generics come in tablets, unlike Avodart and previous generics in soft capsules.
Soft capsules might be uncomfortable if they are stuck inside the mouth or the esophagus. The latest Avodart generics improved the patient convenience.
JW Pharm applied its technology called “self-micro emulsifying drug delivery system” (SMEDDS). SMEDDS converts insoluble agents to soluble ones, making body absorption quick.
The drugmaker unveiled the development of Jdart in March. It was the first in Korea to develop a dutasteride tablet.
JW Pharm completed the patent application for the dutasteride tablet in September last year. Dutasteride is effective in reducing urinary difficulties caused by enlarged prostate and acute cramps that make it difficult to release the urine. The agent is also known to prevent hair loss.
As Avodart’s patent expired in 2016, more than 30 generics have arrived in the market in severe competition.
GlaxoSmithKline, the supplier of Avodart, signed a contract with Teva-Handok to sell Avodart’s identical clone Zygard to counter attacks from generics.
To win the competition against the original treatment, Chong Kun Dang secured the generic exclusivity. Hanmi Pharmaceutical’s copy is only one-third of the size of Avodart.
With JW Pharm’s release of a similar tablet with minimized side effects, the competition in the Avodart-targeting market is likely to intensify.