Development of generic for Pelubi is active

Daewon Pharm’s anti-inflammatory generics for Pelubi, which recorded an outpatient prescription of ₩28.9 billion last year, is actively developing.

 

In July, the first application for permission of generic for Pelubi was received, and nine bioequivalence test plans were approved this year.

 

Generic companies are now developing not only Pelubi, but also Pelubi SR.

 

However, additional indications acquired late through a clinical trial by Daewon Pharm are expected to be protected as long as the PMS expires.

 

According to the industry and the MFDS on the 17th, Mothers Pharm received approval of two bioequivalence test protocols for the generics of Pelubi SR on July 29 and July 31.

 

The first approved bioequivalence test is conducted on an empty stomach, and the second approved test is to determine the equivalence with Pelubi after meals.

 

Earlier in May, generic by Huons was approved for the same bioequivalence test.

 

Daewon Pharm's Pelubi SR is a drug approved in March 2015 and is administered orally after meals twice a day.

 

Pelubi which was approved as a new drug made in Korea in April 2007, is a drug that is administered orally after meals three times a day.

 

Generics for Pelubi by Mothers Pharm and Huons were also approved for bioequivalence tests in March, and are currently ended.

 

In addition, Yungjin Pharm, Nexpharm, and Hutecs were also approved.

 

However, in order for them to obtain and release generic for Pelubi, they must overcome the patent first.

 

Formulation patent for Pelubi is scheduled to expire on November 12, 2028.

 

Starting with Yungjin Pharm at the beginning of this year, Mothers Pharm, Hutecs, Huons, Nexpharm Korea, and Chong Kun Dang in turn requested a trial to confirm the scope of their rights for patent evasion, but a trial decision has not been made yet.

 

In addition, the composition patent of Pelubi SR is listed on the patent list of the MFDS in the.

 

The composition patent is scheduled to expire on October 17, 2033, but there is no patent challenge from generic companies.

 

At the end of July, the first application for Pelubi’s generic was received, but if the patent cannot be overcome even after the product permission, it cannot enter the market for the duration.

 

However, generic companies are confident in the success of the patent challenge and are highly likely to release early.

 

Even so, it is difficult to secure and release all indications of Pelubi and Pelubi SR.

 

In the case of Pelubi, there are antipyretic indications for acute upper respiratory tract infection along with osteoarthritis, rheumatoid arthritis, and low back pain (low back pain).

 

Among them, PMS will expire on September 18, 2021 for antipyretic indications.

 

Generic companies can apply for permission after the PMS expires.

 

In addition, Pelubi SR has indications for osteoarthritis, rheumatoid arthritis, low back pain (low back pain) and post-traumatic pain.

 

Pelubi's antipyretic effect and Pelubi SR's indication for pain were obtained through additional clinical trials after the marketing of Daewon Pharm.

 

The indications for post-traumatic pain in Felubiceron will only expire on June 16, 2024.

 

generic companies are developing generics, excluding additional indications.

 

In the case of Pelubi’s generic, which applied for permission at the end of July, the antipyretic indication for acute upper respiratory tract infection was omitted.

 

In addition, generic for Pelubi SR, which is currently being developed, is expected to exclude the indication for nervous tension post traumatic pain.

 

The recent development of Pelubi's generics shows that its popularity in the market is rising rapidly.

 

Pelubi, which recorded ₩28.9 billion in outpatient prescriptions last year, surpassed ₩10 billion for the first time in 2017.

 

It was only eight years after launch.

 

As PMS already ends in April 2013, it is an analysis that generic companies have confirmed marketability and started developing generics.

 

Pelubi, which did not meet expectations at the beginning of its release, gradually expanded its market share.

 

This also affected the part in which Daewon Pharm acquired the indications sequentially through subsequent clinical trials.

 

When it was approved, Pelubi's only indication was osteoarthritis.

 

Even if another generic is released through the success of the patent challenge, the indications for acute upper respiratory tract fever and post-traumatic pain can be valid.