SK Chemicals said it won a patent for Teglutik Oral Suspension, a treatment for Lou Gehrig’s disease, three months after winning marketing approval.
The patent aims to make Teglutik the nation’s only oral suspension to treat Lou Gehrig’s.
According to the Ministry of Food and Drug Safety, the regulator put Teglutik (ingredient: riluzole) on the list of patented medicines on Aug. 18.
The patent protects SK Chemicals’ manufacturing method of riluzole aqueous suspension until March 2, 2030.
Riluzole, the main ingredient of Teglutik, treats amyotrophic lateral sclerosis (ALS), the so-called Lou Gehrig’s disease.
In May, SK Chemicals obtained the regulatory nod for Teglutik to extend life or delay tracheostomy for ALS patients.
Teglutik is a suspension formulation of previously released riluzole medicines, and the advantage is that patients suffering from dysphagia (dysphagia) can take it more easily through oral injection.
Teglutik’s suspension formulation of riluzole makes it easier for patients with difficulty swallowing to take the oral injection.
SK Chemicals licensed in Tiglutik from ITF Pharma, an Italian drugmaker, and obtained local approval with a similar name Teglutik.
In the Teglutik patent registration, SK Chemicals and ITF Pharma were listed as the patent registrant and the patent holder, respectively.
ITF Pharma won FDA approval for Tiglutic in 2018.
In Korea, authorized Lou Gehrig’s treatments include Sanofi-Aventis Korea’s Rilutek Tab. (riluzole), Yooyoung Pharm’s Yooritek Tab. (riluzole), and Mitsubishi Tanabe Pharma Korea’s Radicut Inj. (edaravone).
However, SK Chemicals’ Teglutik is the only oral suspension.
Attention is on whether SK Chemicals’ Teglutik, with better convenience for medication, will be competent in the local Lou Gehrig’s treatment market.
Lou Gehrig’s is a progressive neuromuscular disease where motor neurons are destroyed, making all kinds of voluntary movements impossible. The disease eventually leads to the stoppage of the movement of the diaphragm, which regulates breathing. The disease is found in about one in 20,000 people.