Generic competition over KRW 56 bil Ibrance market heat up

5 generic companies compete over share of the market that brings in KRW 56 bil a year

Kwang Dong leads generic exclusivity race...completes bioequivalence test after challenging Ibrance’s patent

Kwang Dong Pharmacuetical, Shinpoong Pharm, Daewoong Pharmaceutical, Boryung Pharmaceutical challenge the company’s crystalline form and formulation patent one after another

The competition between 5 companies over their generic versions of Pfizer’s breast cancer treatment ‘Ibrance (palbociclib)’ is heating up.

 

Kwang Dong Pharmacuetical, Shinpoong Pharm, Daewoong Pharmaceutical, and Boryung Pharmaceutical each challenged Pfizer to overcome the crystalline form patent and formulation patent of Ibrance.

 

In terms of acquiring first generic exclusivity, Kwang Dong Pharmacuetical has been leading the race.

 

It is the only company that completed the bioequivalence test for its generic and received marketing authorization.

 

According to industry sources on the 18th, Shinpoong Pharm recently filed a trial to confirm the passive scope of rights of Ibrance’s formulation patent.

 

The company had also previously filed a trial for the invalidation of the same patent.

 

The two trials filed for one patent by Shinpoong Pharm indicates its strong determination to release its Ibrance generic.

 

Ibrance is protected by three patents: the substance patent (10-0669578) that expires in 2027, the crystalline form patent (10-1858913) that expires in 2034, and the formulation patent (10-2068423) that expires in 2036.

 

The strategy of generic companies is to release generics upon the expiry of the substance patent in 2027.

 

Generic companies first challenged the drug’s crystalline form patent.

 

In March last year, after Kwang Dong Pharmacuetical filed a passive trial to confirm the scope of rights of this patent, Shinpoong Pharm, Daewoong Pharmaceutical, Boryung Pharmaceutical, and Samyang Holdings also requested the same trial.

 

The companies had mixed results in the first trial.

 

Shinpoong Pharm and Daewoong Pharmaceutical won the first trial.

 

On the other hand, Kwang Dong Pharmacuetical, Boryung Pharmaceutical, and Samyang Holdings lost their trial.

 

The three companies appealed to the Patent Court of Korea.

 

Kwang Dong Pharmaceutical won the second trial, and a decision has not been made on the appeals filed by Boryung Pharmaceutical and Samyang Holdings.

 

In the case of Boryung Pharmaceutical, the company had also filed a trial to confirm the passive scope of rights apart from the appeal and seized victory in the first trial.

 

In conclusion, out of the 5 companies that are challenging Ibrance's patents, four companies, excluding Samyang Holdings, have succeeded in avoiding Ibrance’s crystalline patent.

 

Daewoong Pharmaceutical, Boryung Pharmaceutical, and Shinpoong Pharm filed challenges against Ibrance’s formulation patent.

 

On the 27th of last month, the companies filed an invalidation trial against Pfizer for Ibrance’s formulation patent.

 

In addition to this, Shinpoong Pharmaceutical also requested a trial to confirm the passive scope of rights for the same patent.

 

In terms of acquiring first generic exclusivity, Kwang Dong Pharmacuetical has been leading the race.

 

It succeeded in sinning the first trial it had filed together with other companies, and completed the bioequivalence test for its generic, becoming the only drug to apply for marketing authorization and receive first generic exclusivity.

 

Ibrance is a treatment for HR+/HER2- advanced/metastatic breast cancer.

 

According to the market research institution IQVIA, Ibrance posted sales of KRW 56.2 billion in Korea last year.

 

In Q1 this year, its sales decreased 13% YoY.