Myung In’s Nuvigil first generic listed for reimb in Korea

Myung In’s narcolepsy drug

Expected to reduce the patients’ financial burden by accepting a price below the calculated price

Wakix and other drugs recently withdrew from the domestic market…low number of patients

Myung In Pharm’s first generic version of the narcolepsy drug Nuvigil (amodapine) is expected to be sold in earnest following its reimbursement listing in June.

 

Currently, narcolepsy treatments are primarily composed of two ingredients: modafinil and amodafinil.

 

With Mitsubishi Tanabe Pharma's ' 'Wakix (pitolisant)' recently withdrawing from the Korean market, fierce competition among existing treatments is anticipated.   Currently, modafinil and armodafinil are primarily used for the treatment of narcolepsy.

 

With Mitsubishi Tanabe Pharma Korea's recent withdrawal of 'Wakix (pitolisant)' from the Korean market, the competition among existing treatments is expected to intensify further.

 

Amidst this situation, Myung In Pharm lowered the price of its generic product at a price below the calculated price and announced plans for aggressive market entry.

 

According to industry sources on the 22nd, two dosages (150 mg and 250 mg) of its Amonil Tab, the first generic version of Nuvigil, will be listed for reimbursement on June 1.

 

This drug is the first generic version of armodafinil, the active enantiomer of Provigil (modafinil).

 

It works by activating dopamine in the brain to promote wakefulness and is characterized by its improved duration of action compared to the original drug.

 

The original amodafinil drug is Teva-Handok’s Nuvigil.

 

Nuvigil was approved for reimbursement in Korea in June 2018 and is competing with existing modafinil preparations.

 

Last year, the amount of outpatient prescriptions for the drug amounted to KRW 1.1 billion, according to UBIST.

 

Narcolepsy is a neurological disorder characterized by excessive daytime sleepiness, hallucinations when falling asleep or waking up, sleep paralysis, and sleep attacks.

 

It is designated as a rare and intractable disease in Korea due to the low number of patients.

 

The prevalence rate in Korea is estimated to be 0.002–0.18%, and it primarily occurs during adolescence or early adulthood before the age of 30.

 

Due to the small number of patients, there are few medications available.

 

For modafinil, there are two products: JW Pharmaceutical's Provigil Tab 200mg and Hanmi Pharmaceutical's Modanil Tab 200mg.

 

For amodafinil, there are only two brands: Nuvigil Tab and the newly approved Amonil Tab.

 

Even Wakix, a new drug that was approved in 2021 and listed for reimbursement that same year, withdrew from the Korean market last year due to the small number of patients and low drug prices.

 

From the perspective of pharmaceutical companies, the domestic market for narcolepsy treatments is not so attractive.

 

Nevertheless, Myung In Pharm is showing enthusiasm, lowering its drug’s price during reimbursement listing.

 

Amonil 150mg is priced at KRW 1,206 per tablet, which is about 59% of the price of the original Nubizil 150mg at KRW 2,027.

 

The price of Amonil 250mg is also significantly cheaper at KRW 1,766, compared to Nubizil 250mg at KRW 2,968.

 

Amonil Tab is used for excessive daytime sleepiness associated with adult narcolepsy, with a recommended dosage of 150 mg once daily in the morning.

 

The maximum daily dose is 250 mg.

 

Therefore, attention is now focused on whether Myung In Pharm, which has been making notable strides in the central nervous system treatment area, will also establish a strong presence in the narcolepsy treatment market with its first generic version of Nuvigil.