Hanmi Pharmaceutical, a South Korean drug company, is set to market Glyterol Inhalation Capsule 110/50 μg, an inhaled asthma medication, in 2023, according to Korean Biomedical Review (KBR).
The original drug’s patent has partially expired so market officials have closely been watching when Hanmi will release Glyterol.
The Ministry of Food and Drug Safety, formerly known as the Korea Food & Drug Administration, said Hanmi’s Glyterol was registered on the list of patented drugs.
Glyterol is Korea’s first generic drug of Xoterna Breezhaler (indacaterol/glycopyrronium bromide) 110/50μg, which is developed by Sandoz.
In June 2021, Hanmi received the drug regulatory body’s approval for Glyterol as a maintenance therapy for patients with chronic obstructive pulmonary disease (COPD). Patients can use Glyterol using Hanmi-Haler, according to approval conditions.
In November 2021, the Korea Intellectual Property Office approved the patent, titled “Dry powder for inhalation formulation and preparation method thereof,” to Hanmi, which will expire on October 14, 2039.
Hanmi earlier filed a patent invalidation lawsuit against Xoterna’s composition patent, which expires in May 2025. In November 2020, the Intellectual Property Trial and Appeal Board (IPTAB) ruled that Xoterna’s composition patent was invalid, according to KBR.
Meanwhile, Hanmi is accelerating the process to distribute Glyterol in Korea. Xoterna’s other patent on “beta 2-adrenalin receptor agonist” is set to expire on January 13, 2023.
A representative of Hanmi said, “We plan to release our product next year when Xoterna’s patent expires.”
Hanmi also sells other generic drugs for asthma, including generic drugs of GSK’s Seretide (fluticasone propionate/salmeterol) and Boehringer Ingelheim’s Spiriva Capsule (tiotropium). The story was published Thursday on KBR, a Korean online news outlet.