99 items were granted generic exclusivity, none reimbursed

Influenced by limit set on consigned bioequivalence tests

Exclusivity benefit obsolete...waste of licensing fees

Companies plan to apply for reimbursement upon patent expiry... stepped pricing system meaningless

▲ Boehringer Ingelheim diabetes combo drug

Although 99 items were granted generic exclusivity, none of the items were granted reimbursement during the period.

 

This was what happened to generics of Boehringer Ingelheim’s Jardiance Duo (empagliflozin+metformin hcl).

 

Although a large number of products were approved and even obtained generic exclusivity, the drugs were unsellable in the market, and the exclusive rights granted for the products became obsolete.

 

According to industry sources on the 11th, the generic exclusivity granted to 99 Jardiance Duo generics ended on August 15th.

 

However, none of the items were listed for reimbursement and sold in the market during the period.

 

This was not unexpected.

 

Although the Jardiance Duo generics succeeded in avoiding subsequent patents and obtained generic exclusivity, they were unable to release their drugs to the market due to a substance patent that was not registered with the Ministry of Food and Drug Safety.

 

The MFDS patent list serves as the standard for granting generic exclusivity.

 

A substance patent for the single ingredient Jardiance is currently listed, but none is listed for Jardiance Duo.

 

Based on the patent list, companies that manufacture Jardiance Duo generics were allowed to release their drugs after approval as they have overcome all of the registered patents by avoiding subsequent patents that are terminated after the substance patent.

 

Thus, all Jardiance Duo latecomers that were approved from November last year to April this year were allowed to be marketed upon approval under the drug approval-patent linkage system, and their generic exclusivity period was also set based on the approval date.

 

The end date was set until August 15th based on the products that were approved in November last year.

 

However, substance patents need to be observed due to the risk of a dispute with the patentee regardless of whether or not it is registered on the MFDS patent list.

 

The substance patent for Jardiance Duo is set to expire on October 23rd, 2025.

 

Ironically, the generic exclusivity of the single-ingredient Jardiance is set to start on October 24th, 2025.

 

In other words, generics of the combination drug Jardiance Duo were unable to be sold in the market even with the generic exclusivity.

 

Then how were 99 items allowed to receive this obsolete generic exclusivity?

 

This is because the restrictions set for the 1+3 consigned bioequivalence tests were implemented in July last year.

 

Pharmaceutical companies that conducted bioequivalence tests after July 2012 could only consign manufacture of same-ingredient drugs for up to 3 pharmaceutical companies.

 

As a result, pharmaceutical companies had entered into consignment agreements before the enforcement of this law and rushed the development of their generics, which resulted in the manufacture of such large number of Jardiance Duo generics.

 

According to the MFDS, Dongkoo Bio&Pharma is currently manufacturing empagliflozin+metformin hcl products on consignment for 24 pharmaceutical companies (71 items in total).

 

Such large-scale consignment manufacture was possible because the generic was developed before the enforcement of the consigned bioequivalence test restriction law.

 

As the approved items may only be sold after 4 years from now, it seems inevitable that all of the test products manufactured for approval will have to bd discarded.

 

This means that much social cost was wasted due to the new regulations.

 

Couldn't the generics rather be regulated through drug prices?

 

The Ministry of Health and Welfare had announced a drug pricing system in July 2020, one year before the enforcement of the consigned bioequivalence test restriction law.

 

The system focused on reinforcing the standard requirements for self-bioequivalence tests and a stepped drug pricing system.

 

Under the new system, generics are required to conduct self-bioequivalence tests and be listed within the 20th in the reimbursement list to maintain its base price, which is 53.55% of the insurance ceiling price of the original drug.

 

However, the system could be bypassed as many items that apply for reimbursement at the same time are listed at the same time and considered a single group, and not discounted their price even if the number exceeds 20.

 

Jardiance Duo generics will also be able to avoid the stepped pricing system by applying for the insurance price at the same time before patent expiry.

 

However, such waste from large-scale approvals will not be made for items that were developed after the bioequivalence restrictions were set last year, as only 4 companies at most will be approved at once.