Generic companies lastly challenge Lixiana patent

last to hop on the patent evasion train

Theragen Etex, Dongkwang Pharmaceutical challenges Lixiana’s formulation patent within a month

10 companies win first patent challenge trial since 2020….seek to release their generic version early, the year after the next

Pic of Lixiana

Generic companies have been filing late patent challenges against Lixiana (edoxaban), the market leader in the direct-acting oral anticoagulants (DOACs) market.

 

This is due to the imminent expiry of the product's formulation patent, which is 2 years away.

 

The strategy of the patent challengers is to avoid the formulation patent and launch generics early upon the expiry of the product patent in November 2026.

 

According to industry sources on the 3rd, Dongkwang Pharmaceutical recently filed a trial to confirm the passive scope of Lixiana's formulation patent against Daiichi Sankyo.

 

Prior to Dongkwang Pharmaceutical, Theragen Etex also filed a challenge to avoid the same patent last month.

 

The interesting fact is that a series of such challenges had ended in the 2020-2021 season.

 

The challenge to the Lixiana formulation patent began in July 2018 when Boryung Pharmaceutical first filed a trial to avoid Lixiana’s patent.

 

Hanmi Pharmaceutical, Chong Kun Dang, Samjin Pharm, Kolmar Korea, Kolmar Pharma, HK.

 

Inno.N, Hutecs Korea followed to receive trial decisions for the same patent.

 

The companies won the first trial after May 2020.

 

In 2021, Dong-A ST and Shinnil Pharmaceutical filed for the same judgment and won the first trial.

 

The original manufacturer of Lixiana, dropped its appeal, and the first-instance victory was finalized as a ruling.

 

This ended the patent challenge, with 10 generic companies avoiding Lixiana's formulation patent once and for all.

 

Now, more than 3 years later, the challenge has resumed with Theragen Etex, Dongkwang Pharmaceutical filing the trials.

 

The analysis is that the companies made the move as the expiry of Lixiana's product patent is now just 2 years away.

 

There are 2 Lixiana patents listed on the MFDS’s green list: a product patent that expires in November 2026 and a formulation patent that expires in August 2028.

 

Generic companies plan to avoid the formulation patent and launch generics of Lixiana early to coincide with the expiration of the product patent.

 

If the companies that won the first trial won the invalidation trial, the patent itself would have been invalidated, rendering no need for latecomers to file separate challenges.

 

However, since the previous companies won the passive scope confirmation trial rather than the invalidation trial, the latecomers must also file individual challenges.

 

Of course, as other generic companies have already won, the chances of success for the latecomers are high.

 

Quarterly DOAC prescriptions (Lixiana, Eliquis, Xarelto, Pradaxa)

Industry insiders raised the possibility of additional patent challenges rising in the future due to Lixiana’s long-term lead in the DOAC market with prescription sales of more than KRW 100 billion per year.

 

According to pharmaceutical market research institution UBIST, Lixiana’s prescription sales were KRW 105.3 billion last year.

 

That is up 9% from the KRW 96.7 billion in 2022.

 

In the first half of this year alone, the drug generated KRW 55.7 billion in prescription sales.

 

Lixiana first became the market leader in 2019 and has maintained its lead ever since.

 

The company attributed the rise in prescription sales to the copromotion synergy with Daewoong Pharmaceutical.

 

Moreover, the gap with the second-ranked drug has been widening upon the expiration of the substance patents of its rivals Xarelto (rivaroxaban) and Eliquis (apixaban).