Eliquis faces 42 generics after patent invalidated

Only NOAC market with generics, 48 apixaban items approved

Wave of generics struck down after March patent invalidation case

Item dominating clinic prescription would win the generic market

The list of generics launched in the New Oral Anticoagulant (NOAC) Eliquis (apixaban) market is getting longer by the day.

 

Especially after generic manufacturing companies won the case invalidating Eliquis’ patent in last March, number of regulator-approved generics has skyrocketed.

 

Ministry of Food and Drug Safety (MFDS) confirmed that the total number of MFDS-approved apixaban medicine products as of Nov.

 

6, including the original Eliquis by BMS, is 84 supplied by 42 companies.

 

19 companies supplying 38 items have been approved by the ministry after the patent was invalidated at a court decision.

 

Daewoong Bio and GC Pharma are a few of latest additions.

 

At the moment, 38 items by 19 companies are listed with reimbursement and competing in the same market.

 

After winning the patent invalidation case, Chong Kun Dang, Alvogen Korea, Huons and Yuhan immediately applied for reimbursement listing and entered the market from last June.

 

Other freeloading pharmaceutical companies did not participate in the patent litigation, but decided to launch their generics expecting the patent to be invalidated.

 

More generics are projected to be released in the future based on the number of approved products.

 

Currently, an appeal against the patent invalidation decision has been filed but is pending at the Supreme Court.

 

But as generic companies won both first and second trials, the Supreme Court would likely to rule in favor of the generics.

 

On Oct.

 

18, the Supreme Court dismissed a trial on a medicine patent invalidation case, finalizing the previous judiciary decision to invalidate the patent.

 

In other words, the generics sales would not have any legal barrier against sales, when the Supreme Court decides to invalidate the medicine patent.

 

As for apixaban market, even the preferential sales approval period on the patent challenger, banning sales of other equivalent generic, has passed already.

 

Three items, including Yuhan Apixaban, were granted with preferential sales period from May 12, 2018, to Apr.

 

2, 2019, but their actual sales were suspended as BMS’ sales ban application was accepted.

 

Sales ban injunction was lifted only after the Patent Court invalidated apixaban patent.

 

Now the key is on how well generic companies would expand the trending NOAC market.

 

Among all NOAC medicine, only Eliquis has generic competitors.

 

As NOACs are mostly used in general hospitals, Korean generic companies are focusing on the clinic market instead.

 

But it seems like it would take some time for NOAC generic market to fully flourish.

 

Since its sales started from June, Chong Kun Dang’s Liquisia made disappointing sales of 178.35 million won (Source by UBIST) until September.

 

Meanwhile, the original Eliquis reaffirmed its market leadership by making accumulated prescription sales of 31.3 billion won by September, hiking up 32.1 percent from the year before.