South Korea’s oral minoxidil market is showing signs of recovery after regulators last year withdrew six generics for failing bioequivalence tests. The Ministry of Food and Drug Safety has just approved Damonoxil, an oral minoxidil tablet from Nova M Healthcare and Binex. This brings the number of approved oral products back to four—the first increase since last year’s purge.
Two days ago, Youngil Pharm won approval to run a crossover trial comparing its new tablet candidates to Hyundai Minoxidil Tablets, the original reference medicine seized in the 2024 crackdown. Under South Korea’s stricter rules, companies must now demonstrate therapeutic equivalence through open-label, two-period trials under fasting conditions.
Industry Shake-Out Continues
Last year’s withdrawals affected branded products from Nupharm, Medica Korea, and Union Pharm—all made by Union Pharmaceuticals after its Uni-Minoxidil tablets failed two trials. The market saw further exits on May 29, when HTB pulled its Mobarin gel and solution, and in March, when two TDS Pharm products expired off the shelves.
Oral minoxidil remains a niche treatment for refractory hypertension in patients who have organ damage or who do not respond to triple-drug therapy. With Damonoxil now approved, the only oral options are Hyundai Minoxidil Tablets, Binex’s Bimo 5 mg, Dongguang’s Minoxidil Tablets 5 mg, and the new Damonoxil.
Topical Foam Sprays Flood the Cosmetic Market
Meanwhile, the topical minoxidil arena is booming, driven by cosmetic demand. On May 28, Hyundai Pharmaceutical added a 5% minoxidil foam spray that uses US FDA–approved minoxidil and no propylene glycol. Days earlier, JW Shinyak launched Mydil 5% foam spray for male and female pattern baldness, part of its expanding hair-care line that also includes finasteride, dutasteride, and cosmeceuticals.
First Korean-Made Foam Generic Takes Aim at Monopoly
On May 26, Raon Pharma introduced Minoxyfoam, the country’s first Korean-made minoxidil foam. Developed by Sinsin Pharmaceutical and marketed by Raon, the product uses local manufacturing and proprietary aerosol technology. It aims to challenge Johnson & Johnson’s eight-year Rogaine Foam monopoly by competing on price and supply.
Related Topics
- Indulekha Launches New Ayurvedic Hair Care Products
- Ouzy Shocks Fans With Hair Transplant Transformation Since Love Island
- Shakira Enters Business With New Hair Care Line
