Which P-CAB generic will come first, K-CAB or Vocinti?

Bioequivalence tests have been conducted with the two drugs as comparators this year

K-CAB generic seeks release in December 2026, the release will depend on whether companies can avoid K-CAB’s patent

Companies have started developing generic versions of the P-CAB (potassium-competitive acid blocker) class gastroesophageal reflux disease (GERD) treatments K-CAB (tegoprazan, HK Inno.N) and Vocinti (vonoprazan, Takeda Pharmaceuticals Korea).

 

The post-marketing surveillance (PMS) period for the original drugs, which are being targeted by the generic companies, is set to end in 2024 and 2025, respectively.

 

The release of their generic versions will then depend on whether they can avoid the originals’ patents.

 

According to industry sources on the 14th, approvals for bioequivalence tests using K-CAB and Vocinti as reference drugs have been continuing this year.

 

In the case of bioequivalence tests filed for the approval of K-CAB generics, starting with SamChunDang Pharm in May, Kukje Pharm, Jinyang Pharm, and Hutecs Korea have been approved to conduct bioequivalence tests with K-CAB.

 

Hanlim Pharm was first to receive approval to conduct a bioequivalence test for its Vocinti generic on September 12th.

 

In terms of the expiry of the PMS term, K-CAB's generics will likely be approved first.

 

K-CAB’s PMS term expires on July 4, 2024, and Vocinti on March 28, 2025.

 

The PMS system also serves a data protection function, therefore generic can only be approved after the end of the PMS period.

 

However, the market release date may be delayed much further as the patent term for the original drug is in effect until 2036.

 

K-CAB and Vocinti

In the case of K-CAB, its substance patent expires on August 25, 2031, and its crystalline patent on March 12, 2036.

 

Over 70 generic companies have filed for trial to avoid the two patents.

 

If the companies succeed in avoiding both patents, the release date of K-CAB generics may be pulled forward.

 

Patent challengers are focusing on avoiding the extended term of K-CAB’s substance patent.

 

If they succeed, they may launch their generic versions after December 6, 2026, the expiration date that had been set before HK Inno.N filed to extend their patent term.

 

On the other hand, if the companies fail, the first generic may only be launched in 2036 after the crystalline patent expires, or in 2031 if the companies only succeed in avoiding the crystalline patent.

 

In the case of Vocinti, one patent expires on December 20, 2027, and the other patent expires on November 17, 2028.

 

No pharmaceutical companies have filed patent challenges yet.

 

But in terms of patent duration, Vocinti ‘s generic can hit the market sooner.

 

However, unlike K-CAB, Vocinti has not been released yet and is non-reimbursed in Korea.

 

If Vocinti is not released in the Korean market before the end of the PMS period, its marketing authorization may be revoked.

 

In this case, there is a possibility that the generic will have difficulty procuring the control drug needed for the bioequivalence test.

 

Also, if Vocinti remains non-reimbursed, the latecomer will have to go through the process of reimbursement listing as a drug subject to pricing negotiations, so it may be reimbursed later than K-CAB generics which will receive a set reimbursement price.

 

Therefore, the launch of the generic drugs will ultimately depend on whether or not the companies succeed in avoiding their patent.

 

An industry official said, "K-CAB had posted sales of KRW 100 billion, so generic companies are very eager to release their generic versions of the drug as soon as possible as its commercial viability has been proven.

 

However, if the companies do not succeed in avoiding the patents, their launch date may be delayed, therefore, releasing a Vocinti generic can also be a good alternative.”