Ranitidine risk comes back as opportunity for Boryung

Since the impurity incident, 2/3 of H2RA prescription volume disappeared

Ranitidine banned, prescription shifts to famotidine and lafutidine

Stogar, Dong-A Gaster and Hanmi Famotidine benefit the most

Korea’s Ministry of Food and Drug Safety (MFDS) has banned all sales of ranitidine drugs from Sept.

 

26 last year.

 

After collecting and investigating ranitidine drugs, the ministry discovered unacceptable level of N-nitrosodimethylamine (NDMA).

 

Also a month later, the ministry banned the sales of 13 nizatidine drugs with the same reason.

 

While the Korean pharmaceutical industry was still shaken by the hypertension drug valsartan, another active pharmaceutical ingredient (API) found with NDMA fluctuated the antiulcer prescription drug market in Korea.

 

Without ranitidine, the H2 receptor antagonists (H2RAs) prescription drug volume shrunk down to one-thirds.

 

But as demand for other H2RAs like famotidine and lafutidine skyrocketed, other antiulcer drug makers like Boryung Pharmaceutical, Dong-A ST and Hanmi Pharmaceutical benefited from the impurity risk.

 

◆ H2RA prescription volume plummets by 64 percent as an aftermath of ranitidine sales ban According to pharmaceutical market research firm UBIST on July 20, the outpatient prescription for H2RA drugs generated 63.2 billion won in the first half of the year, falling rapidly by 64.4 percent from last year at 177.4 billion won.

 

Monthly outpatient prescription volume in H2RA and PPI (Unit: KRW 100 million) Source: UBIST

The staggering result is an aftermath of ranitidine, once dominated the biggest pie in H2RA prescription drug market, and its sales ban imposed after finding unacceptable level of NDMA.

 

While the prescribers turned their heads toward proton-pump inhibitors (PPI) and other antiulcer drugs, approximately two-thirds of H2RA prescription volume disappeared into the thin air in a year.

 

The market research firm analyzes the ranitidine impurity incident would have impacted the prescription drug market even worse, when also counting the ranitidine combination drugs.

 

In the first half of last year, ranitidine combination drug prescription generated 111.4 billion won, a quadruple of ranitidine single drug generating 27.7 billion won.

 

Two of the top selling ranitidine combination drugs—Daewoong Pharmaceutical’s Albis and Albis D—together raised 32.4 billion won in the first half of last year.

 

◆Famotidine and lafutidine sales surge, while nizatidine returns Since October last year, the prescription volume of H2RA drugs besides ranitidine has drastically fluctuated.

 

Five H2RA medicines including famotidine, lafutidine, cimetidine, roxatidine and nizatidine together have made 63.2 billion won.

 

Compared to 38.3 billion won from last year, the figure was pushed up by 65.1 percent.

 

Although the majority of prescription drug market in the first half of the year showed unstable trend amid COVID-19, H2RA market except ranitidine expanded abruptly.

 

It could be viewed as the other H2RAs sharing the ranitidine prescription volume.

 

Monthly outpatient prescription volume in major H2RA drugs from 2018 to 2020 (Source: KRW 1 million) Source: UBIST

The shift in prescription preference is more apparent in the monthly trend of H2RA prescription volume.

 

Since August last year, all H2RAs except for cimetidine recorded increase in prescription volume.

 

For a single drug, famotidine had the steepest rise in prescription volume.

 

In the first half of this year, famotidine drug made 24.8 billion won.

 

Soaring over 3.8 times of last year’s volume, famotidine became one of the top sellers among the H2RAs.

 

In the same time, 16.2 billion won of lafutidine single drugs were prescribed.

 

The volume almost doubled from last year.

 

Nizatidine drugs have made 15.6 billion won, making 1.1 times more than last year.

 

As 13 of nizatidine products were banned in last October, the overall nizatidine prescriptions stagnated for a while.

 

But it bounced back up from early this year, and the overall nizatidine prescription volume surpassed lafutidine from last April.

 

Meanwhile, cimetidine prescription volume fell, although there was no report of NDMA contamination.

 

Cimetidine single drug prescription generated 4.1 billion won in the first half of this year and halved the figure in a year.

 

The setback in API supply seems to have affected a long-term shortage of the finished product and reduced prescription volume.

 

Roxatidine single drug almost doubled in the prescription volume from last year and raised 2.5 billion won, but it still takes the smallest pie in the overall market.

 

◆Stogar makes 10 billion won and Dong-A Gaster makes 5.2 billion won In the H2RA market, Boryung Pharmaceutical, Dong-A ST and Hanmi Pharmaceutical presumably have benefitted the most from the ranitidine impurity incident.

 

Major H2RA drug prescription volume in H1 2018-2020 (Unit: KRW 100 million) Source: UBIST

Boryung Pharmaceutical’s Stogar generated 10 billion won from outpatient prescription volume only and became the most prescribed H2RA single drug.

 

It is on par with Ildong Pharmaceutical’s Curan making 10.5 billion won in the first half of last year.

 

As a result, Stogar’s prescription volume has surged by 58.3 percent from last year.

 

Consisting of lafutidine, Stogar is the first H2RA peptic ulcer treatment to be indicated to eradicate Helicobacter pylori.

 

Boryung Pharmaceutical voluntarily tested four nitrosomines contamination including NDMA, after the government ordered sales ban on ranitidine, and actively promoted the safety of its product supported by the negative test result.

 

5.2 billion won of Dong-A Gaster by Dong-A ST has been prescribed for outpatients.

 

Leaping by 244.0 percent from last year at 1.5 billion won, the drug came second in the H2RA prescription drug market.

 

Dong-A Gaster with famotidine has been indicated to treat gastic and duodenal ulcer, anastomotic ulcer, upper gastrointestinal bleeding, gastroesophageal reflux disease (GERD), Zollinger–Ellison syndrome (ZES), and to improve acute gastric mucosal lesion induced by chronic gastritis.

 

Before the ranitidine risk arose, Dong-A ST signed a co-promotion deal with Ildong Pharmaceutical on Gaster.

 

Ildong Pharmaceutical created an strong synergy effect by concentrating its sales force on Gaster, when ranitidine single drug Curan was banned.

 

As for Ildong Pharmaceutical, it seems to have somewhat recovered from the damage taken with Curan sales ban.

 

Other famotidine drugs like Hanmi Pharmaceutical’s Hanmi Famotidine and Hutecs Korea Pharmaceutical’s Hutecs Famotidine grew sixfold in a year and placed themselves on the leader board.

 

Hanmi Famotidine and Hutecs Famotidine have generated 3.1 billion won and 2.4 billion won, respectively, in the first half of the year.