Hanmi keeps challenging Pfizer’s Champix in smoking cessation drug market
Hanmi Pharmaceutical has decided not to give up on its anti-nicotine therapy and challenge Pfizer’s original treatment, Champix (ingredient: varenicline tartrate), once again.
Earlier, the Korean company successfully released a treatment with the modified salt base but failed as it lost in the patent litigation.
After the patent expired, Hanmi tried again with a product manufactured by another pharmaceutical company. However, it failed again as the Ministry of Food and Drug Safety found impurities in the medicines. On Tuesday, another contaminant, N-nitroso-varenicline (NNV), was detected in Hanmi’s anti-nicotine therapy, Nocotin S, forcing the company to recall the product voluntarily.
However, the company has not given up on its varenicline-based anti-nicotine drug and decided to retry for approval, challenging again with the third generic of varenicline. It has applied for the approval of its novel varenicline generic drug and plans to replace the recalled Nocotin S.
The active ingredient of Nocotin S is varenicline salicylate manufactured by CTC Bio under the consignment of Hanmi. The drug was commercialized in July 2020 after the patent of the original drug Champix expired.
Before introducing Nocotin S, Hanmi Pharmaceutical initially marketed varenicline-based Nocotin, an originally developed anti-nicotine drug with a modified salt base.
However, Hanmi failed to defend its rights of the drug as it lost the patent litigation to Pfizer. The Korean launched Nocotin in November 2018 before the patent of the original substance expired, looking for a chance as the extended substance patent duration does not apply to salt-modified drugs.
The Intellectual Property Trial and Appeal Board accepted Hanmi’s appeal. Still, the Patent Court of Korea ruled in favor of Pfizer, judging that the original and generic drugs had the same purpose of use and effect.
Hanmi later came up with Nocotin S as an alternative as the Ministry of Food and Drug Safety ruled out Nocotin for sales.
However, the company again ran into an obstacle as regulators found impurities in Nocotin S. manufactured by CTC Bio.
Hanmi has recently requested to revive an anti-nicotine drug using varenicline oxalate to regain its damaged trust.
In the anti-nicotine drug market, many pharmaceutical companies have given up developing the generics of Champix. Still, Hanmi Pharmaceutical is not likely to quickly leave the field, according to industry watchers.
It initially entered the anti-nicotine business with Nicopion (ingredient: bupropion hydrochloride), a generic version of Wellbutrin by GSK. In addition, it took the lead among domestic pharmaceuticals in targeting the patent of Champix with a modified salt base.
When the request for a trial to verify the rights of the drug went unsuccessful, the company also filed an appeal for patent invalidation. The company even ran programs for quitting smoking with its employees whenever it launched a new product.
Considering all the efforts Hanmi Pharmaceutical has made so far, the company is likely to continue trying to patent its products and expand its market share, an industry executive said.