Dipharma SA and Alvogen has announced that the pharmaceutical product Diterin (Sapropterin Dihydrochloride 100mg tablets), indicated for the treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU), is now commercially available in the Republic of South Korea.

Diterin is the only drug approved in South Korea by the Korean Ministry of Food and Drug Safety for the treatment of HPA due to PKU, a rare genetic disease leading to an abnormally high concentration of phenylalanine (Phe) in the blood, which can cause brain damage to people affected by it.

“We are happy to provide Diterin to the South Korean market, as this treatment can make a difference in the management of Phe levels for many patients suffering from lifelong PKU, contributing to prevent the appearance of potential transient to non-reversible mental impairment” said Peter Vazharov, Alvogen S&M VP, Asia Pacific together with Marc-Olivier Geinoz, chief executive officer of Dipharma SA., who added “As part of Dipharma’s mission, we will continue to expand our portfolio of high-quality products - including Diterin - to offer improved solutions to each and every patient suffering from inborn errors of metabolism all around the world.”

Dipharma S.A. also confirms that patents and patents applications were filed protecting Diterin and its active pharmaceutical ingredient - Sapropterin Dihydrochloride - in many countries of the world, including South Korea. This commercial launch is resulting from an exclusive collaboration agreement between Dipharma SA. And Alvogen, under which Alvogen owns the exclusive rights to commercialize Diterin 100mg tablets in the Korean market. Dipharma S.A. is currently working to make Diterin available in all the countries worldwide.

Diterin (Sapropterin Dihydrochloride) is a synthetic copy of the naturally occurring co-factor tetrahydrobiopterin (BH4) that works in conjunction with the enzyme phenylalanine hydroxylase (PAH) to metabolize the amino acid phenylalanine (Phe).

Diterin is the first generic oral drug for the treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU) in patients of all age who have shown to be responsive to BH4. If left untreated, the disease leads to abnormally high levels of Phe in the blood, which can result in permanent neurological disorders in paediatric patients and cognitive deficits and psychiatric disorders in adults. By offering the body a synthetic copy of BH4, Diterin works as a complement to a low-Phe diet, to help keep the level of Phe low in the body, and to preserve the brain from damage. Diterin was developed by Dipharma SA, Switzerland. Diterin is a trademark owned by Dipharma SA.

Dipharma SA. is a Swiss pharmaceutical company specialized in developing high quality, improved, medicines for rare diseases. Dipharma SA. is part of a third generation group of family companies grown to a global presence.


Alvogen is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brands, over-the-counter brands (OTC) and biosimilar products for patients around the world.