Roche said it would withdraw Parkinson’s syndrome treatment Madopar Tab. 125mg and 250mg from the Korean market, after 30 years of the drug sales since the local marketing approval in 1992.

The company announced that it would voluntarily withdraw the permit for Madopar Tab. (levodopa 200mg/benserazide 50mg) and discontinue the domestic supply after Dec. 31, 2021.

The company will later disclose when it will stop supplying Madopar Tab. 125mg (levodopa 100mg/benserazide 25mg).

To inform the supply halt, Roche Korea and its joint distributor Handok are sending out official notices to related organizations, including medical societies, hospitals, clinics, and wholesalers.

The withdrawal of the two types of Madopar came after Myungin Pharm’s generic drug Myungdopar got health insurance benefits in August. Myungdopar 50 mg and 200 mg, containing the same ingredient as Madopar Tab., became reimbursable at 206 won ($0.18) per tablet.

Since introducing Madopar in Korea in 1992, Roche has been struggling to supply the drug due to the low drug price for a long time. However, as the generic drug recently became reimbursable, which leads to a price cut of the original medicine, Roche decided to withdraw Madopar.

As the government has yet to decide on the insurance benefits for Myungdopar 25/100mg, Roche will set the schedule for Madopar 125mg supply discontinuation later. However, the company said that the plan provides sufficient time for local patients to switch from the original drug to the generic copy.

After a drugmaker’s voluntary withdrawal of drug approval, physicians can still prescribe the drug for six additional months under the grace period of the health insurance program. If Roche completes nullification of the permit by early next year, physicians can still prescribe the two types of Madopar at reimbursed rates by the first half of next year.

However, Roche said it would maintain the local supply of Madopar Dispersible Tab. 125 and Madopar-HBS Cap. 125. The usage of these two drugs is significantly less than Madopar 125mg and 250mg, but there is no generic drug that can replace the former two. This was the reason to maintain the supply of Madopar Dispersible and Madopar-HBS, the company said.

In Parkinson’s syndrome treatment, it is important to control the type and administration of drugs depending on changes in the patient’s symptoms. Thus, patients with Parkinson’s syndrome are known to require various drug dosages and formulations.

Madopar Dispersible Tab. 125 dissolves in water, used in patients with difficulty swallowing or those in need of fast action of the drug. Madopar-HBS Cap. 125 is designed to release the medication slowly, used to control the “on-off phenomenon” (variations in drug efficacy) occurring in the long-term use of levodopa.

“We will make all efforts to help patients smoothly switch from Madopar Tab. 125 mg and 250mg to other treatment options,” an official at Roche Korea said.