19 Korean companies to challenge Entresto patent

Elyson Pharm first files negative scope confirmation, Chong Kun Dang, Hanmi, Daewoong and Boryung to follow

A series of South Korean pharmaceutical companies are challenging the patents on Novartis’ heart medicine Entresto (sacubitril, valsartan plus sodium salt hydrate complex).

 

Starting with Elyson Pharm filing a patent trial as a first in last year, 18 other companies expressed their intention to release their generics early.

 

According to a pharmaceutical industry source on Feb.

 

16, South Korean pharmaceutical companies like CTC Bio, Boryung Pharmaceutical, Yuyu Pharma, Corepharm Bio, Kyperion, MFC, Sinil Pharmaceutical, Daewon Pharmaceutical, Yooyoung Pharmaceutical, Hana Pharm, Hanlim Pharm, Ahn-gook Pharm, Hanmi Pharmaceutical, Chong Gun Dang, Daewoong Pharmaceutical, Genuonesciences, Samjin Pharmaceutical and Kolmar Pharma submitted a patent trial request from Feb.

 

9 through 15 and joined the race to challenge Entresto patent.

 

Same as Elyson Pharm that started the process earlier, the group of South Korean pharmaceutical companies have filed a negative scope confirmation on Entresto’s crystalline form patent.

 

Currently, total four patents are listed under Entresto brand.

 

Aside from the crystalline form patent to be expired on Sept.

 

21, 2027, the drug has a product patent expiring in July 2027 and two composition patents expiring January 2029.

 

For an early release of the Entresto generic, the group of South Korean companies would have to also overcome other outstanding patents.

 

By successfully evading the four patents, the follow-on drug companies would be able to launch their generics after April 13, 2022, when the original drug’s post-marketing surveillance (PMS) ends.

 

Norvatis released Entresto, a hard-to-treat heart failure drug, in the South Korean market in October 2017.

 

In the first year of launch in 2018, the drug generated 6.3 billion won from outpatient prescription, and the sales tripled in just two years in last year making 20.3 billion won.

 

South Korean companies have been highly interested in such profitable market for their Entresto generics.

 

Some companies have reportedly initiated bioequivalence test.

 

A pharmaceutical industry associate told, “As Elyson Pharm challenged Entresto patent first, other companies planning to release generics early are also trying to overcome the patent.”