Eplerenone was first approved in Korea

Eplerenone by Theragen Etex was approved

The original, Pfizer’s Inspra was not introduced in Korea

Pfizer’s Inspra (Eplerenone)

The drug for hypertension and chronic renal failure, which was not introduced in Korea, was first approved by a small and medium-sized pharmaceutical company in Korea.

 

The MFDS approved a drug for data-based re-evaluation of two doses of Theragen Etex's Eplerenone formulation on the 21st.

 

Eplerenone is generic for Inspra, which was approved by the US FDA for hypertension treatment in 2002.

 

It was approved as a treatment for congestive heart failure in 2003.

 

Inspra is a drug developed by Pharmacia before the acquisition of Pfizer.

 

It is known as an Aldosterone antagonist, such as Spironolactone, as a potassium-sparing diuretic agent.

 

Pfizer did not introduce Inspra instead of launching 'Aldactone film coated tab' with spironolactone component in Korea.

 

It is known that Inspra did not achieve sales performance as expected due to Spironolactone formulation overseas.

 

Pfizer did not introduce Inspra while launching 'Aldactone film coated tab' containing Spironolactone in Korea.

 

It is known that Inspra failed to achieve as much as expected due to the Spironolactone formulation overseas.

 

Pfizer has its best-selling drug, Norvasc which is a calcium channel blocker that dilates blood vessels and improves blood flow.

 

Pfizer acquired Pharmacia in 2002 and secured famous pipelines such as Celebrex.

 

Since it was not introduced in Korea, there are no licenses or patents on the Orange book of the MFDS.

 

Therefore, there is no difficulty for generics to enter the market because the original has not been introduced in Korea.

 

Theragen Etex also recognized this and belatedly started to approve the item.

 

Eplerenone from Theragen Etex can be used for hypertension and chronic heart failure (when receiving basic treatments such as angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, β blockers, and diuretics).

 

The amount of outpatient prescriptions for Aldactone, was ₩2.8 billion last year.

 

Although the market size of drugs for hypertension and chronic heart failure is large, new drug competition is fierce, so the sales volume of Eplerenone, which was introduced lately in Korea, will only be known after time.