Korean drugmakers are expected to roll out generic copies of Pfizer’s smoking cessation therapy Champix (varenicline tartrate), as they received a favorable decision regarding the leading drug’s substance patent.
Champix has been enjoying a rapid sales growth on the government’s anti-smoking policy supports.
The Intellectual Property Trial and Appeal Board recently ruled that 22 Korean companies did not infringe on the patent of Champix concerning the extension of the medicine's patent duration.
The 22 firms include Hanmi Pharmaceutical, Chong Kun Dang, JW Pharmaceutical, Daewoong Pharmaceutical, Samjin Pharm, Jeil Pharmaceutical, Ildong Pharmaceutical, and Kolmar Korea.
Champix’ substance patent expires in July 2020, but the ruling allows the 22 drugmakers to avoid Pfizer’s patent and release generic versions in November.
Hanmi Pharm is particularly drawing attention among the 22 firms, as it will own two kinds of the smoking cessation medications that contain varenicline tartrate and bupropion hydrochloride.
Pfizer’s Champix has been dominating the anti-smoking treatment market.
According to data from IQVIA, Champix sold 64.96 billion won ($60.45 million) last year, growing more than 10 folds in four years from 6.3 billion won in 2014.
Hanmi Pharm has been striving to make Nicopion (ingredient: bupropion hydrochloride), a generic version of Wellbutrin by GSK, a rival drug against Champix. However, Nicopion’s sales reached only 781 million won last year.
With the latest ruling, however, Hanmi Pharm’s efforts since 2015 to avoid Champix’ patent will bear fruits, as the company will own smoking cession treatments containing both varenicline tartrate and bupropion hydrochloride.
Although other companies also have drugs made out of the two agents, Hanmi Pharm is the only firm engaged in marketing activities such as giving incentive money to those who quit smoking in an anti-smoking club, created by Nicopion marketers.
With the existing networks of Nicopion, Hanmi Pharm is likely to launch full-scale marketing in the quit-smoking therapy market.
“Competition among generic drugs will start in November as many pharmaceutical companies will avoid Champix’ substance patent. Hanmi Pharm’s move will be most aggressive as it already has an existing network,” said an official at a patent team at a local drugmaker.