Topiramate XR generics may be released soon

Use to treat epilepsy

Series of generic companies apply for approval to MFDS…Government notified so to SK Chemical, the company that owns the original 'Qudexy XR Cap'

국내 유일 토피라메이트 서방캡슐 <큐덱시>

Generic companies have applied for approval of new follow-on drugs of 'Qudexy XR Cap,’ an extended-release topiramate formulation used for epilepsy, to the Ministry of Food and Drug Safety.

 

The follow-on drugs that applied for approval this time are film-coated tablet formulations rather than capsule formulations, and whether the generic companies will be able to avoid Qudexy’s patent with the changed formulation is gaining attention.

 

According to industry sources on the 5th, 2 products with the same ingredient (topiramate) as 'Qudexy XR Cap have recently applied for approval to the MFDS.

 

The MFDS notified the original company upon the generic companies’ application because the original company has a patent (extended-release topiramate capsules) registered on the list in accordance with the approval-patent linkage system.

 

Generic companies have also applied for approval of their Qudexy XR Cap generics in December last year and in May this year.

 

The industry is looking at Introbiopharma as the likely developer of a follow-on Qudexy XR Cap.

 

This is because Introbiopharma conducted a bioequivalence test for its Topimed XR tablet (tentative name) with Qudexy XR Cap as a control drug.

 

Qudexy XR Cap, which is supplied by SK Chemicals in Korea, is the first extended-release topiramate formulation in Korea.

 

While the existing immediate-release topiramate formulation is taken twice a day, the extended-release formulation is absorbed slowly into the body and can be taken once a day, improving the patients’ convenience in administration.

 

The drug was developed by the U.S.

 

pharmaceutical company Upsher-Smith Laboratories and approved by the FDA in 2014.

 

In Korea, it was approved by the Ministry of Food and Drug Safety in August 2017.

 

Qudexy XR Cap is indicated to treat epilepsy ▲as monotherapy for the treatment of partial-onset seizures with or without secondary generalized seizures in children and adults 6 years of age and older; ▲partial-onset seizures, primary generalized tonic-clonic/convulsive seizures, and seizures associated with Lennox-Gastaut Syndrome with or without secondary generalized seizures in children and adults 2 years of age and older that are not adequately controlled by existing first-line antiepileptic drugs.

 

The drug had been granted reimbursement since February 2018.

 

Last year, outpatient prescriptions amounted to KRW 3.5 billion based on UBIST.

 

As a single item, its sales are not very high.

 

However, topiramate-based formulations account for KRW 30 billion of the KRW 80 billion antiepileptic drug market and are the most prescribed ingredient.

 

This is why analysts saw high potential for the XR formulation.

 

This explains the rapid move among generic companies to develop extended-release formulations.

 

The patent for Qudexy XR Cap, which is registered on the MFDS Green List, is expected to last until January 2034.

 

The patent covers the extended-release topiramate capsule.

 

As the generic companies applied for film-coated topiramate tablet formulations, it is analyzed that the generics will likely be released to the market apart from the registered patent.

 

"The patent currently registered for Qudexy XR Cap protects the capsule form, but the follow-on extended-release formulations the generic companies applied for are film-coated tablet formulations, so companies will likely be able to avoid the patent," said a pharmaceutical industry insider.

 

"It seems that the generic companies have adopted a patent avoidance strategy to quickly develop their respective products.”