Kolon Pharma’s antifungal treatment, Nelclear Topical Solution (terbinafine hydrochloride), hasn’t even hit the market, but the fight over its future is already in full swing. Hanmi Pharmaceutical has secured regulatory approval for a generic challenger, Mujonal Max Topical Solution, while Genuone Sciences has entered the patent battle—escalating tensions before Kolon can even bring its high-dose terbinafine treatment to market.
Nelclear, imported by Kolon from Spain’s Alfasigma, received over-the-counter (OTC) approval in 2023. But while Kolon has been holding off on launch to secure health insurance coverage — a rare move for an OTC drug — Hanmi and Genuone have been moving fast, both filing scope confirmation actions against Nelclear’s key formulation patent, which remains valid until 2034.
Hanmi Pharmaceutical secures approval for Korea’s first OTC generic rival to Kolon’s Nelclear, adding competition to the nail fungus market.
Hanmi Pharmaceutical secures approval for Korea’s first OTC generic rival to Kolon’s Nelclear, adding competition to the nail fungus market.
Hanmi fired the first shot, securing approval from the Ministry of Food and Drug Safety (MFDS) on Monday for Mujonal Max Topical Solution—the first generic alternative to Nelclear. Already a dominant player in Korea’s antifungal market with its Mujonal franchise, the drugmaker sees a lucrative opening. Meanwhile, Nelclear is positioning itself as a cost-effective alternative to Dong-A ST’s blockbuster Jublia (efinaconazole), which pulled in 29 billion won ($20 million) in revenue in 2023 and held strong with 25.3 billion won last year.
Hanmi officials did not immediately respond to a request for comment on their strategy. Dong-A ST, facing fresh competition, also did not immediately weigh in on the potential market shake-up.
By securing the first generic approval, Hanmi is now in a prime position to gain first-mover advantage—if it can successfully invalidate the patent. That could give Hanmi a head start over Genuone in commercializing the first Nelclear alternative.
But Hanmi isn’t the only company making a move. Korea’s top-tier contract drugmaker Genuone Sciences has followed suit, filing its own patent challenge with Korea’s Intellectual Property Trial and Appeal Board (IPTAB). Under Korea’s Patent-Approval Linkage System, first-generic exclusivity goes to the earliest successful challenger, making the legal outcome critical.
The two companies submitted their challenges on Oct. 24 and Nov. 7 last year, respectively, securing their eligibility. However, their regulatory filings—on Oct. 25 for Hanmi and Jan. 9 for Genuone—may ultimately decide who enters the market first.
The Nelclear dispute is notable for two reasons.
First, patent fights over OTC drugs are rare. The last high-profile case involved Dong-A Pharmaceutical’s Noscarna Gel, a scar treatment that saw a rush of generic competitors, including SinSin Pharm, GC Biopharma, and Tai Guk Pharm, all attempting to secure approvals while challenging the patent.
Second, Nelclear’s launch remains uncertain. Originally slated for release in early 2024, Kolon is still tied up in the reimbursement process with no clear timeline. Company officials could not be reached for comment on the expected launch or ongoing delays.
If the patent battles move fast, Nelclear and its generics could land on shelves at the same time, potentially reshaping prescribing trends. Should Nelclear secure reimbursement, it could emerge as a lower-cost alternative to Jublia, disrupting the market for prescription nail fungus treatments.
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Kim Ji-hye jkim404@docdocdoc.co.kr
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