Whanin, begins development of first generic for Fycompa

3 years remaining until the expiration of the product patent

Antiepileptic drug Fycompa by Eisai

Whanin, for the first time as a domestic pharmaceutical company, started developing generics for antiepileptic drug Fycompa by Eisai.

 

If the generic development proceeds smoothly, it is expected that it will be aprproved next year as soon as possible.

 

The MFDS approved the bioequivalence test plan for 'Peranel 6mg' submitted by Whanin on the 8th.

 

Peranel is an imaginary item that has not yet been approved, and is the same ingredient as Fycompa.

 

The bioequivalence test is conducted for the purpose of securing equivalence by comparing the absorption rates of Peranel and Fycompa in 56 healthy adults.

 

The test was designed to run through May next year.

 

Anyway, application for permission is possible only in July of next year.

 

This is because Fycompa's PMS will expire on July 9th next year.

 

Generics can be applied for approval only after the PMS period of the original has ended.

 

Since Fycompa's material patent is due to expire on October 13, 2023, it will take three years to get to the market.

 

Whanin filed a decision to confirm the passive scope of the right to evade the crystalline form patent scheduled to expire on October 14, 2026 in February.

 

Since Myungin Pharmaceutical also requested the relevant judgement, it is highly likely to develop generics along with Whanin.

 

Fycompa is a selective non-competitive a new mechanism of epilepsy treatment that antagonizes the AMPA (α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid) receptor, and has been designated as a new drug for six years of reexamination (PMS) by the MFDS.

 

In 2017, it was approved by the US FDA as a monotherapy for patients with epilepsy (epileptic) partial seizures over 12 years of age with or without secondary systemic seizures.

 

Based on UBIST, last year's domestic prescription amount was ₩3.4 billion.

 

It has the advantage of being convenient for epilepsy patients to use, especially once a day.