Pradaxa and Xarelto to face generic market opening up soon

From July next year, six generics with preferential sales rights to enter NOAC market

Brilinta and Galvus generic to be launched in advance, Betmiga generic preferential sales benefit terminated

Six South Korean pharmaceutical companies that successfully evaded Pradaxa (dabigatran) and Xarelto’s (rivaroxaban) patents would release generics in advance in July next year.

 

The industry predicts the non-Vitamin K antagonist oral anticoagulants (NOAC) market currently led by the originals would take a sharp turn soon.

 

Moreover, a generic version of dipeptidyl peptidase-4 (DPP-4) inhibitor Galvus (vildagliptin) would be launched soon with the preferential sales rights.

 

Also, Brilinta (ticagrelor) generic market would be opened late next year with 25 South Korean companies backed by the preferential sales right.

 

◆ Generic market for Pradaxa and Xarelto to open in July and October next year, respectively On Dec.

 

28, the Ministry of Food and Drug Safety (MFDS) and the Korean Intellectual Property Office (KIPO) announced the preferential sales rights would be granted on total 37 items from next year.

 

First, four companies that overcame NOAC Pradaxa’s patent are to release their generics early on July 18 next year.

 

Intro Bio Pharma’s Dabican, Aju Pharm’s Dabitran, Jinyang Pharm’s Pradabi and Huon’s Hubitran are the generic by the four companies.

 

The four companies won the patent dispute against the original drug company Boehringer Ingelheim in January 2019.

 

The obtained preferential sales rights are to last until April 2022.

 

Another NOAC, Xarelto is also expecting its generic versions to emerge after Oct.

 

4 next year.

 

Hanmi Pharmaceutical’s Riroxban and SK Chemical’s SK Rivaroxaban have been preparing for the launch.

 

The wildcard is actually Chong Kun Dang, who challenged Xarelto’s product patent that neither one of the two companies could not overcome.

 

If the court rules in favor of Chong Kun Dang by Oct.

 

4 next year, the company would be able to market the product even before Hanmi Pharmaceutical and SK Chemical regardless of the preferential sales rights.

 

So far, the NOAC market was predominantly occupied by the original Eliquis, Pradaxa, Xarelto and Lixiana.

 

But, soon the generics would tackle the market with the boost from Xarelto generic.

 

In fact, Eliquis’ patent was challenged the first.

 

In May 2018, Chong Kun Dang and Yuhan Corporation received the preferential sales rights and launched their generics after June 2019.

 

Now the preferential sales period has ended and 12 generic companies are expanding their market share.

 

And in next year, only Lixiana would be the one without generic competitors.

 

Considering Lixiana generic would tap on the market in 2026, the original would dominate the market for a while longer.

 

◆25 Brilinta generics to rush into the market from November next year An antidiabetic DDP-4 inhibitor developed by Novartis, Galvus is expecting its generic version to be released in advance on Aug.

 

30 next year Ahn-gook Pharm (including Ahn-gook New Pharm) would exclusively practice the generic preferential sales right.

 

The South Korean company succeeded in nullifying the extended original patent term.

 

But the relevant patent dispute has not been settled completely, yet.

 

As Novartis took the case to a higher court, the Supreme Court would be making the final decision.

 

After Nov.

 

21 next year, Brilinta’s generics would be released early.

 

About 30 pharmaceutical companies in South Korea challenged AstraZeneca’s antiplatelet drug patent.

 

Ultimately, Chong Kun Dang successfully won 25 claims and received the preferential rights.

 

◆Preferential sales right period on Betmiga generic ended, nine generic companies ready to take off Meanwhile, some generics’ preferential sales benefit would be terminated soon.

 

On Jan.

 

8, the benefits on desvenlafaxine generics would be taken away.

 

Its original is Pfizer’s antidepressant Pristiq Extended Release Tablet.

 

Whanin Pharm, Nexpharm Korea, Myung In Pharm and Hanlim Pharm got the preferential sales rights in last April.

 

From Feb.

 

3, two mirabegron generics would no longer protected by the preferential sales rights.

 

Astellas’ overactive bladder treatment Betmiga is the original.

 

As Hanmi Pharmaceutical and Chong Kun Dang successfully challenged the patent, they respectively released Mirabek and Selebeta.

 

As Betmiga generates around 70 billion won annually, the generic companies would aggressively jump into the market after February when the preferential sales period ends.

 

Currently, nine companies, including Hanmi Pharmaceutical, Chong Kun Dang, JW Pharmaceutical, Daewoong Pharmaceutical and etc., have evaded the patent and some of them even completed the bioequivalence test and are fully prepared for the launch already.