GL Pharmtech said Tuesday that its new dry eye treatment, 'Recoflavone,' has completed patent registration in the United States, Europe, and Japan.
Recoflavone is a dry eye treatment developed from a drug candidate introduced by GL Pharmtech from Dong-A ST (Dong-A ST) in 2017. Following the introduction of the candidate molecule, GL Pharmtech continued formulation research for eye drop development and clinical trials. On September 8, it obtained product approval from the Ministry of Food and Drug Safety as 'Recodue Eye Drops 5% (Recoflavone hydrate).'
Alongside the commercialization of Recoflavone, GL Pharmtech pursued the securing of intellectual property rights both domestically and internationally.
First, it registered two patents in Korea related to eye drop compositions for treating dry eye containing Recoflavone. It secured the 2022 patent 'Eye Drop Composition Containing Recoflavone for Treating Dry Eye' and the subsequent 2023 patent 'Eye Drop Composition Containing Recoflavone for Treating Dry Eye and Method for Manufacturing the Same.'
Subsequently, it completed registration of this patented technology in Japan in April, Europe in July, and the United States in October. This has established a foundation for rights protection in major global markets.
The company explained that the overseas patents are significant as they cover not only rights to the Recoflavone raw material but also eye drop compositions and formulation technologies secured during development as a dry eye treatment.
Recoflavone has been recognized as an independent new drug ingredient in international pharmaceutical classification systems. The Collaborating Centre for Drug Statistics Methodology, under the World Health Organization (WHO), recently assigned Recoflavone the ATC (Anatomical Therapeutic Chemical) code 'S01XA37.' This code is a new classification corresponding to 'Other Ophthalmological Preparations' among ophthalmic medicines.
The ATC code is one of the international standards used by the WHO to systematically classify pharmaceuticals worldwide according to the site of action (Anatomical), therapeutic purpose (Therapeutic), and chemical/pharmacological properties (Chemical).
It is recognized as an 'internationally accredited classification system' for medicines used globally. It can be said to be an indicator that formally proves a specific ingredient has value as an independent pharmaceutical.
A GL Pharmtech official said, "Securing the ATC code allows us to establish a pharmaceutical status recognized with global credibility. It also facilitates overseas technology exports and global approval procedures."
Following its earlier listing under the WHO International Nonproprietary Name (INN), Recoflavone has now secured an ATC code, establishing an identification system as an independent pharmaceutical ingredient in the global market.
GL Pharmtech plans to actively pursue strategies for entering overseas markets and global commercialization of Recoflavone.
A GL Pharmtech official said, "Recoflavone has proven that it is growing into a new drug asset capable of global commercialization based on domestic approval, patent registration in the United States, Europe, and Japan, and listing in WHO international classification systems. We will gradually expand our entry into global markets and commercialization."
in THEBIO
