Hanmi Pharmaceutical is busy preparing for a market release of inhaled asthma medication, Glyterol Inhalation Cap. 110/50 μg.

As the original drug's patent expired partially, industry officials are closely watching when Hanmi will release Glyterol.

The Ministry of Food and Drug Safety said Hanmi’s Glyterol was registered on the list of patented drugs on Wednesday.

Glyterol is the nation’s first generic drug of Xoterna Breezhaler 110/50μg, developed by Sandoz. Active ingredients are glycopyrronium bromide and indacaterol maleate.

In June last year, Hanmi received the regulatory approval for Glyterol as maintenance therapy to relieve symptoms of chronic obstructive pulmonary disease (COPD). According to approval conditions, a patent can inhale Glyterol using “Hanmi-Haler.”

In November, Hanmi received the patent, titled “Dry powder for inhalation formulation and preparation method thereof,” from the Korea Intellectual Property Office, with patent number 10-2330428-0000. However, the patent expires on Oct. 14, 2039.

Earlier, Hanmi 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.

Hanmi is accelerating the process to roll out Glyterol in Korea. As Xoterna’s other patent on “beta 2-adrenalin receptor agonist” expires on Jan. 13, 2023, the company aims to release the generic drug next year.

As Hanmi was the first local drugmaker to invalidate the patent of the original drug Xoterna, the company got to sell its generic drug exclusively for nine months, from Jan. 14, 2023, to Oct. 13, 2023.

“We plan to release our product next year when Xoterna’s patent expires,” an official at Hanmi Pharmaceutical said.

Hanmi also sells three generic drugs for inhaled asthma medications, including a generic drug of GSK’s Seretide (fluticasone propionate micronized, salmeterol xinafoate micronized) and another copy of Boehringer Ingelheim’s Spiriva Cap. (tiotropium bromide monohydrate).