Pharma, preparing for the future…generic launch in 2030s

Priority marketing authorization for generic versions of K-CAB and Tagrisso will be effective after 2031

Taleaje generic submitted for approval…it can be launched on or after June of 2031

Product photos of Tagrisso (left) and K-CAB (right).

Are they already preparing for the future? The Korean pharmaceutical industry is preparing for generics that would be launched five years later. They are also fiercely competing to secure priority marketing authorization by filing patent applications and seeking approvals.

According to the Ministry of Food and Drug Safety (MFDS), 'Otinib tablet (Chong Kun Dang),' a generic version of the non-small cell lung cancer treatment Tagrisso (osimertinib), was approved on the 27th and also secured the priority marketing authorization. 

When assigned a priority marketing authorization, the drug receives an exclusive sales period of 9 months, during which the sale of generics containing the same active ingredient is banned.

However, the effective date of the priority marketing authorization is not approaching soon. It is set to begin on December 28, 2023, and terminate on September 27, 2034. Approximately 8 years remain until the product launch. This is because the Tagrisso patent is set to expire on the specified date.

Generic versions of K-CAB (tegoprazan), a P-CAB for gastroesophageal reflux disease (GERD), are increasingly receiving approvals. Yet, the priority marketing authorization is scheduled to take effect after August 26, 2031.

Until now, pharmaceutical companies that received K-CAB generic approvals include GC Cross, Withus Pharm, Genuonesciences, Korea Drug, Ildong Pharmaceutical, KyungDong Pharm, and Hutecs Korea.

As K-CAB is a mega-blockbuster item generating over KRW 200 billion in annual sales, numerous companies are competing for approvals to gain pre-occupancy in the generic market.

Generics to Daiichi Sankyo's neuropathic pain treatment Taleaje (mirogabalin besilate) can be launched on or after 2031.

Five pharmaceutical companies have applied for approval of their products containing mirogabalin besilate. Several companies have started patent challenges, excluding substance patents. Huons, Daewoong Pharm, Dong-A ST, JW Pharmaceutical, KyungDong Pharmaceutical, and Samjin Pharm.

Five pharmaceutical companies that successfully challenged patents would be leading candidates to obtain priority marketing authorization. Despite this advantage, more than 5 years remain until the launch of generics, as the patent on the active ingredient is set to expire on June 4, 2031.

Taleaje is still a non-reimbursed drug, and its sales cannot be estimated yet. Despite this circumstance, Korean generic companies have anticipated the bright future of the Taleaje market and have entered the race to secure a generic position.