After failing to outrival Pfizer in the anti-smoking treatment market with a generic drug, Hanmi Pharmaceutical has released another copy to win over Pfizer’s original treatment Champix.
The local drug company said it has started selling "Nocotine," a self-developed nicotine fighting treatment using oxalate as the base, from November.
Nocotine uses varenicline oxalate hydrate as the main ingredient, attaching oxalate to the anti-smoking substance varenicline. It is a generic copy of Pfizer’s Champix, replacing the base with oxalate.
Hanmi said Nocotine showed better stability against heat and ensured uniformity in quality. In the company’s phase-1 test, Nocotine proved equivalence with the original imported drug, the company said. Hanmi now has both varenicline and bupropion, leading substances in the anti-smoking treatment market.
Hanmi must have thoroughly prepared for the launch of the new generic drug of Champix, observers said.
According to IQVIA’s data, Pfizer’s Champix sold 64.96 billion won ($57.84 million) last year, more than 10 times increase in four years from 6.3 billion won in 2014. Hanmi’s Nicopion, the only rival drug against the original, sold only 781 million won last year.
Pfizer’s lead continued in the first half this year. Although Champix sales fell to 23.7 billion won in the first half, down 36.46 percent from 37.3 billion won a year earlier, Nicopion sales plunged to 276 million won, down 42.97 percent from 485 million won a year earlier.
Through the launch of the new generic drug of Champix, Hanmi aims to expand a share in the smoking cessation market.
Hanmi is likely to emphasize the difference of Nocotine from other Champix imitations and utilize the sales networks built on the sale of Nicopion, observers said.
While Pfizer chose tartrate as the base for Champix, Hanmi picked oxalate for Nocotine. Kyungdong Pharmaceutical used besylate as the base for a Champix generic, and C-TRI, Yungjin Pharm, and Unimed Pharm chose salicylate.
Pfizer, which sells more than 6.5 billion won worth Champix a year, has teamed up with Yuhan Corp. to defend against attacks from generic drugmakers, led by Hanmi.
As the sales of nicotine fighting medicines are deeply related to the government’s policy support, generic drug manufacturers urgently wish to obtain the insurance coverage for their generic drugs before the product launching date of Nov. 14, officials said.
“The National Health Insurance Service is reportedly preparing a list for insurance coverage regarding Champix generic drugs,” a pharmaceutical source said. “If the listing goes after Nov. 14, companies will find it difficult to push sales aggressively because the products won’t be reimbursable.”