How difficult is it to get a generic drug for Seretide on the market?

Recently, Hengrui issued an announcement stating that, in accordance with the latest policy of the State Food and Drug Administration on drug review and approval, combined with the company's actual situation, it has submitted to the State Food and Drug Administration an application for withdrawal of salmeterol ticasone powder inhalation drug registration.

(Source: Juchao Information Network)

Hengrui stated that the withdrawal is based on the adjustment of the company's internal R&D program.

There are no generic drugs listed in China

Salmeterol ticasone powder inhalation in the form of a combination (bronchodilator and inhaled corticosteroids) is intended for the regular treatment of reversible airway obstructive airway diseases, including asthma in adults and children.

Salmeterol ticasone powder inhalation was developed by GSK.

In 2001, salmeterol ticasone powder inhalation was approved to enter the Chinese market, and its indication was chronic obstructive pulmonary disease (COPD), and its trade name was seretide; in 2010, a new indication for asthma was added in China.

In 2013, the seretide compound patent expired in China.

(Source: CDE official website)

However, since Seretide is a combination product of medicine and equipment, the development of such inhaler generic products is far more difficult than that of oral solid preparations.

It is worth mentioning that CP Tianqing’s salmeterol inhalation powder mist, which had entered the priority review on the grounds of "major special project", was only one step away from the market.

In January of this year, some insiders pointed out that Hengrui's salmeterol ticasone powder inhaler will be approved this year, but now it is unlikely.

Two consecutive pharmaceutical giants have broken down.

Public data shows that in 2019, the global sales of inhaled preparation hospital ports was 48 billion U.