True Set, a triple hypertension therapy, to face generics

Jeil Pharm received approval for bioequivalence trial, set to be released in August 2025

Generics of Yuhan’s True Set Tab., a triple-combination drug for hypertension with rapid sales growth, are already gearing up for competition.

 

True Set, a triple-combination drug that contains telmisartan, amlodipine besylate, and chlorthalidone, received approval in August 2019.

 

Subsequently, True Set was released to the market in November following reimbursement approval.

 

True Set’s re-examination period is set to expire in August 22, 2025, which is a year and 8 months from now.

 

Given these circumstances, generic companies are actively pursuing opportunities for generic entry.

 

The MFDS approved Jeil Pharm’s bioequivalence trial protocol for JLP-2202 on 21st.

 

A comparative drug contains Telmisartan 80mg, Amlodipine Besylate 6.935mg, and Chlorthalidone 25mg as active ingredients.

 

A currently authorized drug for the market is True Set Tab.

 

80/5/25mg.

 

Released in November 2019, True Set Tab.

 

recorded an annual outpatient prescription sales of 10 billion won, in just two years.

 

According to the data from UBIST, True Set Tab.’s outpatient prescription sales recorded 16.8 billion won, with a cumulative outpatient prescription sales in Q3 reaching 13.4 billion won, breaking last year’s record and showing potential for rapid growth.

 

Currently, Daiichi Sankyo Korea’s Sevikar HCT (Olmesartan Medoxomil/Amlodipine Besylate/Hydrochlorothiazide), Amosartan Plus (Amlodipine Camsylate/Losartan potassium/Amlodipine Camsylate), and True Set (Telmisartan/Amlodipine Besylate/Chlorthalidone) are dominating the triple-combination drug market.

 

Among these, generics for Sevikar HCT has already been released in the market.

 

Amosartan Plus and True Set remain exclusive in the market.

 

However, drug product patent for Amosartan Plus is expiring in November 2036.

 

Additionally, Amosartan Plus contains Amlodipine Camsylate, which is exclusively produced by Hanmi Pharm, making it difficult for generic companies to approach immediately.

 

Since True Set does not have a relevant patent, and its re-examination is set to be completed three years from now, generic companies have been eyeing the drug.

 

Korean pharmaceutical companies are facing limited opportunities for generic development due to the scarcity of original drugs with expiring patents.

 

Therefore, many companies, including Jeil Pharm, are awaiting to seize the opportunity to manufacture True Set generics.