Eliquis generics will soon return to market

97 drug patents set to expire in 2H 2024

Generic versions of Eliquis exit market in 2021 due to Supreme Court ruling…seeks to reenter market upon patent expiry in September

First exclusivity generic rights for Monterizine, Fycompa, and Jublia will expire...Will latecomer generics enter the race?

Pic of Eliquis

The patent for Eliquis (apixaban), a direct-acting oral anticoagulant (DOAC) worth KRW 80 billion a year, will expire in September.

 

As such, generic versions of Eliquis, which were withdrawn from the market in 2021 due to the Supreme Court's reversed decision, will re-enter the market thereafter.

 

The return of generics is expected to once again shake up the DOAC market, which includes Eliquis.

 

In addition, the first generic exclusivity of Hanmi Pharmaceutical's Monterizine (montelukast-levocetirizine), Eisai’s Fycompa (perampanel), and Dong-A ST’s Jublia (efinaconazole) will expire in the second half of this year.

 

This raises the possibility of further entry of generics upon the expiry of the preferential marketing period.

 

Eliquis generics withdrawn by Supreme Court ruling will reenter after September According to the Korean Intellectual Property Office, 97 patents for 43 products will expire in the second half of this year alone.

 

The most notable product among those is BMS’s Eliquis.

 

Its product patent expires on September 9th.

 

Except for the product patent, the rest of the patents have been invalidated by generic companies.

 

The generic companies planned to relaunch the product in September to coincide with the expiry of the product patent.

 

The companies have launched Eliquis generics since June 2019.

 

However, the companies completely withdrew from the market nearly 2 years later in April 2021.

 

Their products are returning to the market after more than 3 years.

 

Their entry and withdrawal from the market was decided upon by the 1st to 3rd trial results of the patent suit.

 

The generic companies won the first and second rounds of the product patent litigations in 2018 and 2019, based on which the companies launched their products.

 

The generics quickly gained influence in the market, generating nearly KRW 10 billion in prescription sales in their second year.

 

In Q1 2021, just before they were withdrawn from the market, the market share of apixaban-based DOACs reached 23%.

 

But the tables turned in April 2021 when the Supreme Court reversed and remanded the trial court's decision.

 

The companies pulled the infringing products from the market.

 

Eliquis succeeded in regaining its unrivaled position in the apixaban-based DOAC market.

 

During that period, Eliquis’s sales continued to grow steadily.

 

Prescriptions for Eliquis jumped from KRW 52.3 billion in 2020 to KRW 63.1 billion in 2021, the year the generics were withdrawn.

 

The prescription volume increased further to KRW 73.7 billion in 2022 and KRW 77.3 billion last year.

 

Quarterly Prescription Sales of Eliquis and Eliquis Generics

The return of generics after September is expected to significantly disrupt the overall DOAC market.

 

In the past, Eliquis generics have quickly gained market share upon launch.

 

In addition, they have secured plenty of new clients, selling generics of Xarelto (rivaroxaban), a drug in the same class whose patent expired before Eliquis.

 

A total of 49 companies have authorized generics of Eliquis.

 

14 of them were selling the product before it was pulled from the market.

 

The industry expectation is that around 15 of them will re-enter the market after September.

 

In addition, patents for AstraZeneca's ovarian and breast cancer drug Lynparza (olaparib), Celgene's multiple myeloma drug Revlimid (lenalidomide), and Takeda Pharmaceuticals’ gastroesophageal reflux disease drug Dexilant DR (dexlansoprazole) will expire in the second half of the year.

 

In the case of Revlimid, generic companies have already evaded the crystalline patent, which expires in September this year.

 

Its product patent expired in 2017, and 4 companies had received approval for their generics then and have been selling generics.

 

In the case of Dexilant DR, 6 companies, including Yuhan Corp, succeeded in avoiding all the remaining patents, including the formulation patent, which expires in July, and 1 generic has already been approved.

 

In the case of Lynparza, one patent expires on the 23rd of this month.

 

However, no company has yet challenged the development of Lynparza generics.

 

First generic exclusivity of Monterizine-Jublia expires...opens the door for generic competition The exclusive sales period of major generics that have entered the market with a first generic exclusivity marketing authorization (first generic exclusivity) will also expire in the second half of this year.

 

After the first generic exclusivity period expires, likely, latecomer generics will likely also enter the market.

 

the first generic exclusivity period for Hanmi Pharmaceutical's asthma drug Monterizine expired on the first of this month.

 

Monterizine’s patent was challenged by 20 companies, including Han Wha Pharm.

 

The companies won the trial on 4 formulation patents last September and were granted a first 9-month generic exclusivity period.

 

Within 9 months of launch, the companies won nearly 20% share in the montelukast+levocetirizine combination market.

 

In Q1 this year, prescriptions for Hanmi Pharmaceutical's Monterizine amounted to KRW 4.3 billion, while the combined prescriptions for its generics amounted to KRW 1.1 billion.

 

However, it is understood that there have been no follow-up actions made for the development of Monterizine generics thereafter.

 

Industry analysts say this is because the market size of Monterizine is not large, around KRW 15 billion a year, and competition has been fierce, with as many as 20 companies having received the first generic exclusivity rights.

 

On the 13th of this month, the distribution period for Eisai’s Fycompa generics for epilepsy will expire.

 

Myung-in Pharm and Whan In Pharm successfully challenged and evaded Fycompa’s patent in 2020.

 

Since October last year, Whan In Pharm’s Peranel Tab and Myung In Pharmaceuticals’s Pericompa Tab have been available as generic versions of Fycompa.

 

However, the performance of the two generics during the marketing period has not been good.

 

From the fourth quarter of last year to Q1 this year, the cumulative sales of Peranel and Pericompa were only around KRW 20 million each, compared to the KRW 2.2 billion earned by the original product during the same period.

 

This is due to the high preference for original drugs in the CNS area.

 

Dong-A ST’s nail fungus treatment Jublia will also expire in November.

 

16 companies challenged Jublia’s patent, and Daewoong Pharmaceutical and Dongwha Pharmaceutical received the first generic exclusivity rights to market its generics.

 

Dongwha Pharmaceutical later handed over the license to Huons.

 

So the other companies that challenged Jublia’s patent but did not receive the first generic exclusivity are expected to join in the generic competition.

 

Given the summer peak in sales for nail fungus (onychomycosis) treatments, the companies may well join the competition next spring.

 

Jublia’s sales last year were KRW 31.8 billion.

 

This is up slightly from the KRW 31.4 billion in 2022.