Sprycel patent to expire soon…market shift worth KRW 40 bil

Boryung is preparing generics entry, filing claims to confirm the scope of a right·trial to invalidate a patent

The release of generics·incrementally modified drugs in the U.S. is expected around September…North America sales amount to KRW 2 trillion

Viatris is likely developing the generic version of Sandostatin LAR, Novartis’ anticancer therapy

Sprycel’s compound patent for its protein tyrosine kinase inhibitor expired in March.

Following the patent expiration for blockbuster medicines in the United States this year, generics are expected to enter the market.

 

Likewise, market shifts are expected with the development and launch of generics in South Korea.

 

According to an overseas research agency, the top 10 blockbuster medicines with patents expiring in 2024 include Sprycel, Tysabri, Myrbetriq, Victoza, Sandostatin LAR, Dulera, Oxtellar XR, and Venofer.

 

Among these, Sprycel has the highest sales, with prescription sales totaling over KRW 2 trillion in the United States.

 

Tysabri and Myrbetriq recorded sales totaling approximately KRW 1.3 trillion and KRW 870 billion, respectively.

 

Victoza and Emflaza have also recorded sales of KRW 710 billion and KRW 340 billion, respectively.

 

Dulera, Sandostatin LAR, and Oxtellar XR have reached significant external growth, with sales of KRW 260 billion, KRW 160 billion, and 150 billion, respectively.

 

They are showing solid sales in the United States.

 

However, the sales performance of these drugs in South Korea is quite different from the positions in the United States.

 

Following the expiration of patents in the United States, medicines that are expected to launch in South Korea are likely limited to BMS’ Sprycel (dasatinib), a leukemia treatment, Novartis’ Sandostatin LAR (octreotide acetate), used to treat cancer, due to non-reimbursement issues.

 

According to the pharmaceuticals market report, Sprycel sales in South Korea for the past five years (2019-2013) amounted to KRW 29.6 billion, KRW 34.1 billion, KRW 390 billion, and KRW 40.1 billion.

 

The Sandostatin LAR inj sales in 2019, 2020, 2021, 2022, and 2023 amounted to KRW 9.6 billion, KRW 9.3 billion, KRW 9.3 billion, KRW 8.9 billion, and KRW 8.6 billion, respectively.

 

South Korea sales performance of medicines with U.S.

 

patents expiring in 2024.

 

(from the top) Venoferrum, Victoza, Sandostatin LAR, Sprycel, and Tysabri.

Sprycel, which received FDA approval in 2006, has been indicated for the second-line treatment of patients who do not respond to other medicines, such as Gleevec and Tasigna.

 

Subsequently, it has been prescribed as the first-line treatment since 2010.

 

Sprycel’s compound patent for its protein tyrosine kinase inhibitor expired in March, so generics are expected to launch starting in November due to agreements made with other companies, including Apotex, ahead of the patent expiry.

 

Xspray Pharma also initially planned to release the incrementally modified drug (IMD) Dasynoc within the second half of 2023.

 

Yet, it is expected to be released in Q3 this year due to monitoring several issues.

 

Three-types of patents protect Sprycel.

 

Its substance and use patents have expired in April 2021 and March 2024.

 

The crystalline form patent will remain until February next year.

 

In South Korea, Boryung is actively pursuing Sprycel generics, filing claims to confirm the scope of a right and challenging substance patent through invalidation trial.

 

Although the Sandostatin LAR patent has already expired in Europe and Japan, its generic version has not been released due to the delicate manufacturing process.

 

However, Viatris is likely challenging the original product.

 

JW Pharmaceutical’s iron therapy, Venoferrum Inj (Ferric Hydroxide Sucrose Complex), and Novo Nordisk’s diabetes drug, Victoza inj (liraglutide), have been launched in South Korea.

 

Since these drugs generated KRW 3.2 billion and KRW 170 million, respectively, last year, generic entries would not experience much growth expansion.

 

Eisei’s Tysabri Inj (natalizumab), a multiple sclerosis therapy, generated sales ranging between KRW 30 million and KRW 60 million, but did not experience significant external growth.