The direct oral anti-coagulant (DOAC) market is changing shape at an accelerated pace.

This is due to the series of patent expiries of original drugs that had recorded high sales, mainly in the cardiology departments of university hospitals and clinic-level medical centers.

#In particular, with the accelerated entry of generic drugs (generics), whether companies of original drugs will be restructuring their business units is also attracting attention.

According to industry sources on the 18th, generic versions of original DOACs from major global pharmaceutical companies have recently been launched or announced one after another upon the originals’ patent expiry.

DOACs that are currently prescribed in internal medicine hospitals and clinics and form the major market in Korea are Bayer’s Xarelto (rivaroxaban), Boehringer Ingelheim’s Pradaxa (dabigatran), BMS’s Eliquis (apixaban), and Daiichi Sankyo’s Lixiana (edoxaban).

Among these, Xarelto’s decline in the prescription market has become more pronounced in recent years with its patent expiry in 2H 2022, and the bulk of domestic generics versions that followed.

According to the drug research institution UBIST, Xarelto’s prescriptions plummeted 37% from KRW 49.4 billion in 2022 to KRW 31 billion in 2023. The downward trend has continued in Q1 this year, recording sales of KRW 7.6 billion.

In addition, another blockbuster, BMS’s Eliquis, is also set to go off patent in 2H this year.

As a result, generic versions of this drug are also expected to flood the market once the patent expires in September, which is expected to affect prescriptions. For reference, Eliquis has continued to dominate the clinical scene, with prescriptions totaling KRW 77.3 billion last year. In Q1 this year, its sales amounted to KRW 19.3 billion, but the general prospect is that this sales flow will change after the launch of its generics.

In fact, major domestic companies are already preparing to launch generic versions of Eliquis. For example, Dongkook Pharmaceutical recently received approval from the Ministry of Food and Drug Safety for “Apigaban,” an apixaban generic.

These changes are expected to solidify the sole lead of Daiichi Sankyo's Lixiana, which has been strengthening its market dominance in the field.

Lixiana, which is marketed by Daewoong Pharmaceutical, has recently surpassed Eliquis in sales and solidified its dominance in the field.

Last year, Lixiana's sales in Korea reached KRW 105.3 billion, and in Q1 this year, the drug posted 27.7 billion won in sales, continuing on its upward trend.

"The sales of DOACs do not fluctuate much due to their need in clinical practice," said a professor of cardiology at A University Hospital, who requested anonymity. "But if generic versions are released, prescriptions will naturally be dispersed due to drug prices.”

He added, "Due to rising interest in its utility after its reimbursement approval following transcatheter aortic valve implantation (TAVI) procedure, and due to the need for its continued use, pharmaceutical companies will essentially seek to own one product. It will be interesting to see how the global pharmaceutical companies that own the original products respond."

The industry is watching BMS's moves following the patent expiration of Eliquis.

BMS has recently undergone a major restructuring at its headquarters level.

Last month, BMS reported Q1 earnings that beat expectations, with sales of multiple myeloma drugs ‘Revlimid’ and ‘Eliquis’ coming in higher than expected.

However, one-time costs related to recently closed M&A deals turned the quarter into a loss, and the company said it would focus its resources on R&D programs that will provide the biggest return on investment going forward.

In the process, the company announced that it would lay off 2,200 employees this year, discontinue some development programs, consolidate operations, and reduce management layers. In fact, after the BMS headquarters’ announcement, restructuring started in Japan and elsewhere.

This is why there is a lot of industry speculation on whether the announcement will affect its Korean subsidiary as well.

The series of generic Eliquis drugs that are set to be released upon the original drug’s expiry is also adding strength to the speculation. AstraZeneca also recently withdrew its diabetes drug Forxiga (dapagliflozin) from the Korean market after the launch of its generic versions, closed down the division, and offered voluntary retirement programs.

In other words, some worry that global pharmaceutical companies will again launch early retirement programs following the patent expiry of their original drug and the launch of generics.

However, BMS Korea denied any such plan.

BMS Korea said, "We have no plans set following Eliquis’s patent expiry. We are alternating activities in the domestic market with Pfizer. Our plans at the headquarters level were implemented to strengthen our portfolio through recent M&A and intensive investment in R&D, and are independent of the Korean situation. At this time, we do not have any plans related to Eliquis’s patent expiry."