Generics for Galvus will be listed next month

Promotion of the MOHW's Amendment of the Drug Benefit List and the Upper Limit Table (Draft)

It can be sold immediately after changing the terms of the company's permission and completing approval from the MFDS

Price for Tamiflu Capsule 75mg was adjusted by 2.6% according to the actual transaction price survey of pharmacies

Generics, which had patent disputes with Galvus, a DPP-4 inhibitor-based diabetes treatment, will be listed in earnest next month.

 

This is because companies applied for a change in permit conditions and the MFDS approved it, making it possible to sell it immediately.

 

According to the industry, the MOHW is pushing for a revision (proposal) of the drug benefit list on February 1.

 

There are a total of five items available for registration next month, including Ahngook's Avusmet 50/500mg, Ahngook newpharm's Vildamet 50/500mg, Kyongbo's Vilda 50mg, Korea United Pharm's Healusmet, and Samjin's Vilguard M 50/500mg.

 

Earlier, these items completed the item approval process last year, but their registration was suspended.

 

This is because it could not be sold before March 4, the expiration date of Galvus' patent duration, due to the conditions of permission.

 

The original Galvus has been filing a patent lawsuit for the release of these generics.

 

After the Supreme Court's appeal was rejected on October 28 last year, the expiration date of the patent was confirmed to be March 4 this year, and generic companies also submitted a "patent-related confirmation" to the MFDS.

 

Therefore, generic companies applied for permission to change to the MFDS between December 20 and 22 last year, and the MFDS completed approval between the 14th and 17th.

 

The change is "the case where it is determined that it does not infringe on patent rights" in the existing "sale after the expiration of the patent duration." As a result, companies will be able to sell patents immediately under the condition that they do not infringe on them, and the MOHW will include five items that were suspended after deliberation as of the 1st of next month.

 

Meanwhile, Price of Tamiflu Capsule 75mg will be adjusted 2.6% next month to reflect the results of the pharmacy's actual transaction price survey.

 

The government implemented a large-scale reduction in drug prices of 3,829 items as of the 1st of this month after the actual transaction price survey, of which some data were found to be missing, reflecting the drugstore's claim price for Tamiflu 75mg Capsule.