Sama Pharm’s ‘Daxas’ generic approved

The only company to succeed in avoiding Daxas’s patent

With all other companies failing their attempt at patent invalidation, Sama succeeds in commercializing the first generic in 2 years after its patent evasion

Sama Pharm received approval for the first generic of the COPD treatment ‘Daxas (roflumilast, AstraZeneca Korea)'.

 

As Sama was the only company that succeeded in avoiding the composition patent of Daxas, if the generic is released immediately, the company will be able to preoccupy and monopolize the market for the time being.

 

The Ministry of Food and Drug Safety approved Sama Pharm’s ‘Samaloflu 500mg microgram tablets’ on the 13th.

 

The drug is a generic drug of Daxas 500 micrograms tablets, and the first generic of its kind to be approved in Korea.

 

The drug may be used as add-on therapy to bronchodilator treatment or as maintenance treatment of severe chronic obstructive pulmonary disease (COPD) is associated with chronic bronchitis in patients with a history of symptom exacerbations.

 

Patients over the age of 18 may take a single tablet of the drug once daily with or without meals.

 

Daxas, which was developed by Takeda pharmaceuticals in Japan, was approved in Korea in May 2011.

 

AstraZeneca Korea, while acquiring Takeda’s respiratory treatment division, had acquired the domestic marketing authorization for Daxas in Korea as well.

 

Daxas, which is a PDE4 inhibitor that inhibits factors related to the progression of COPD, has been received with positive reviews for its convenient single table, once-daily dosed regimen According to IQVIA the company sold around ₩1.6 billion in sales last year.

 

Sama pharm had attempted to avoid Daxas’ composition patent since 2019.

 

In the May of 2019, the company filed a defensive confirmation trial for the scope of rights to avoid Daxas’s patent, which was received by the Intellectual Property Trial Appeal Board in the March of the following year.

 

The original developer did not file a suit to protect its patent, and Sama’s patent avoidance was confirmed in May of the same year.

 

2 years later, the company was finally approved the marketing authorization for its product.

 

Other companies have also challenged Daxas’s patent but failed.

 

Dong-A ST among other pharmaceutical companies had filed for patent invalidation but were all rejected.

 

Accordingly, other pharmaceutical companies that joined in the suits also dropped their claims.

 

As a result, Sama became the only pharmaceutical company to succeed in challenging Daxas’s patent.

 

With Sama’s sales in action for respiratory disease treatment, the approval of Daxas’s first generic from Sama Pharm is expected to raise the market competitiveness of the company.

 

In a clinical trial conducted on 33 healthy adults, the bioequivalence of Simaloflu in comparison to Daxas was demonstrated with a confidence interval of 90%, within the log 0.8 - 1.25 range.