Domestic pharmaceutical companies are continuing to challenge Pfizer’s smoking cessation medication, Champix (ingredient: varenicline), which currently has a monopoly on the market.

Of the prescription drugs, including Varenicline and Bupropion, Champix accounts for 80 percent of the domestic market. Champix had a slow start following its local launch in 2007 but has grown rapidly with the government’s anti-smoking project, surpassing the sales of 40 billion won ($35.5 million) last year.

Sales in the first half of 2014 stopped at 2.6 billion won but rocketed to 25.2 billion won a year later, thanks to the government’s policy.

Domestic pharmaceuticals have also begun to develop Champix’s generics and incrementally modified drugs. Hanmi Pharmaceuticals launched Nicopion (ingredient: Bupropion) in 2014 but failed to break Pfizer’s monopoly on the market.

Kolmar Korea has recently jumped in the race to develop an improved version of Champix, along with Hanmi, Jeil Pharmaceuticals, and Kyung Dong.

The Ministry of Food and Drug Safety has approved phase 1 clinical trial plans for Kolmar’s investigational drug KKM-164. KKM-164 contains a slightly modified version of Champix’s main ingredient, varenicline.

Kolmar Korea will conduct clinical trials to compare the safety and pharmacokinetic properties of KKM-164 and KKM-164R in 32 healthy male subjects at Dong-A University Hospital, the company said.

Kolmar Korea, as a contract manufacturing organization, will make contracts with other pharmaceutical companies after it completes the development process, a company official said.

The domestic market for smoking cessation treatment has grown in the past three years since the government launched a national anti-smoking project.

The government is currently subsidizing the costs of anti-smoking medications and nicotine supplements for smokers trying to quit for eight to twelve weeks and cover the cost of the 12-week program upon the subjects’ successful completion. The government will expand the coverage to those who have tried but failed to quit up to three times a year.

Champix’s patent expires in July 2020, a one year and eight-month extension on the original expiration date of Nov. 14, 2018.

Pharmaceutical companies are currently locked in patent litigations that will decide whether domestic companies can release new drugs before or after 2020.