18 Champix IMD suspected of selling before patent expiration

MFDS reviewing administrative measure, license revoked if confirmed

Pfizer

18 incrementally modified drugs (IMDs) of Champix (varenicline) are undergoing administrative measure for selling the products before the original’s patent was expired.

 

Some of their item approvals have been revoked by the related administrative measure.

 

Before the Champix’ patent expires next month, the follow-on drug market would fluctuate depending on the administrative measures.

 

Korea’s Ministry of Food and Drug Safety (MFDS) announced on June 11, the ministry’s regional offices are reviewing 18 IMDs (nine 0.5 mg products and nine 1 mg products), which have been accused of going on sale before the original extended the patent term.

 

The licenses on Korea Prime Pharm’s Champion in 0.5 mg and 1 mg tablets have been revoked by related statutes.

 

Administrative measures on other items would be finalized when the regional offices complete respective reviews.

 

Apparently, these items are suspected of going on sale before Champix extended the patent, although they stated the sale would be withheld until the expiration date as they were approved by the health authority.

 

Champix’ substance patent expiration date before extension was on Nov.

 

11, 2018.

 

And extended term would expire on July 19, 2020.

 

Based on the Korean court’s ruling, most of the IMDs have gone sale from Nov.

 

14, 2018, when the original’s patent expired.

 

But when the Supreme Court overruled the preceding decision and disapproved of IMDs evading patent infringement during the extended patent term, all IMDs have ceased manufacturing and sales.

 

Instead, they are to resume the sale starting from July 19, when the extended patent term expires.

 

The items receiving the administrative measure were supposed to resume the sale from next month.

 

But, the sales plan could be scrapped as they are suspected of selling the products before the patent expiration.

 

Relevant pharmaceutical companies would be affected as the item approval on an IMD selling before the patent expiration is immediately revoked, according to the highest level of administrative measure.