Hanmi returns with salt-modified Champix generic

Releasing generic before patent expiration revoked Nocotine’s license, company receives approval on Nocotine S

66 generic items from 33 companies now ready to enter the market as original patent expires

Product image of Nocotine S tablet

Hanmi Pharmaceutical is trying the Champix (varenicline) generic market for the second time.

 

Initially, the license on the Korean company’s generic Nocotine tablet was revoked, but it came back to the market with Nocotine S tablet with different substance.

 

On July 20, Hanmi Pharmaceutical announced the launch of a varenicline generic Nocotine S indicated for smoking-cessation program.

 

This marks Hanmi Pharmaceutical’s second trial in the Champix generic market.

 

In 2018, Hanmi Pharmaceutical released Nocotine tablet, but its license was revoked by Ministry of Food and Drug Safety (MFDS) on July 14.

 

The revocation was ordered due to the generic sales before the expiration of Champix patent.

 

Nocotine and Nocotine S are not the same; they share the main active pharmaceutical ingredient of varenicline, but they each have different salt base.

 

Nocotine has ‘oxalate hydrate’ and Nocotine S has ‘salicylate.’ According to the Pharmaceutical Affairs Act, a generic item may apply for marketing approval for the sales after the expiration of the original patent term, but selling it before the patent expiration would cancel the generic’s license.

 

Hanmi Pharmaceutical originally reported MFDS to release the generic to the market after the original’s patent is expired, but apparently the Korean company sold the product before the expiration.

 

MFDS has reportedly accused the company of the generic sales before the original patent expiration based on supply history and investigation.

 

18 items from nine companies including Hanmi Pharmaceutical were revoked of the marketing approval—two items each of Kyung Dong Pharm’s Renico tablet, Daehan New Pharm’s Nico-X tablet, Mediforum Pharm’s Nicofence tablet, Unimed Pharm’s Nicoban tablet, Jeil Pharm’s Zerofix tablet, Chong Kun Dang’s Chamclean tablet, Korea United Pharm’s Stobacco tablet, and Korea Prime Pharm’s Champion tablet.

 

The original Champix’ substance patent was supposed to expire on Nov.

 

13, 2018.

 

But as Pfizer Pharmaceutical Korea applied for patent extension, the expiration date was pushed to July 19, 2020.

 

On Apr.

 

27, Hanmi Pharmaceutical returned and applied for marketing approval on Nocotine S with the same substance as Champix.

 

The company’s proactive move was to immediately release the product from July 20, when the original’s extended patent term would end.

 

Apparently, none of other eight companies with license revocation has applied for the varenicline generic’s license again like Hanmi Pharmaceutical has with the modified salt base.

 

Regardless, the other companies who did not receive the license revocation order are allowed to release their varenicline generics from July 20 as the original’s patent has expired.

 

MFDS confirms 66 items from 33 companies are ready for sales.