Balloon effect from impurity measures?

Since the discontinuation of Ranitidine, the number of generics such as Famotidine, Laputidine, & Artemisia Princeps

Inhibition of sales of all products due to detection of impurities leads to intensification of generic competition for similar drugs

Recently, the number of new anti-ulcer drugs that enter the market is rapidly increasing.

 

As the alternative drug market expanded after the Ranitidine’s withdrawal due to excessive detection of impurities in September last year, pharmaceuticals are also actively targeting the generic market.

 

In addition to H2 receptor antagonists such as Famotidine and Laputidine, similar generic products such as Esomeprazole and Artemisia Princeps have also increased significantly.

 

It is pointed out that the generic turmoil in the similar drug market is intensifying due to the balloon effect following the government's strong follow-up of impurities.

 

According to the MOHW's revised notice on a partial revision of Criteria for pharmaceutical reimbursed list & reimbursed upper limit table, from April 1, 9 generic products of “Famotidine 20mg” will be listed on the pharmaceutical reimbursed list.

 

Mirae Pharm, TDS Pharm, Theragen Etex, CMG Pharma, PMG　Pharm, SCD Pharm, Daehan New Pharm, and Daewoong Bio sell Famotidine product.

 

Kukje pharm, Arlico, Newgen Pharm, Korea Prime Pharm, Medix Pharm, Eden Pharma, Youngil pharm, Generic products with 'Laputinine', which were approved by eight companies including Kukje pharm, Arlico, Newgen Pharm, Korea Prime Pharm, Medix Pharm, Eden Pharma, Youngil pharm, were also newly added to the list.

 

Famotidine and Laputidine are H2 receptor antagonist drugs and are used for gastric ulcer and duodenal ulcer.

 

It is analyzed that drug companies are actively entering the alternative drug market since last year's banned sales of Ranitidine.

 

The MFDS banned the sale of all products of 'Ranitidine' in late September last year.

 

The market was virtually decided to exit due to the excess detection of the carcinogen N-nitrosodimethylamine (NDMA).

 

September 2019 and April 2020 Famotidine 20mg (left) and Laputidine 10mg (right) Number of health insurance benefits registered (Unit: number, Data: the HIRA

According to the HIRA, on September 1, last year, a total of 35 other companies were listed for Famotidine 20mg before the ban on the sale of Ranitidine was imposed.

 

However, Famotidine 20mg, listed on April 1, increased 56 companies by 60%.

 

In the case of Laputidine 10mg, the number of products on the reimbursed list increased 11 products from 29 in September last year to 40 in April.

 

The surge in prescriptions of similar drugs after the ban on the sale of Ranitidine drugs is also analyzed as a factor that has pushed the market for pharmaceutical companies.

 

According to UBIST, a pharmaceutical research institute, in December of last year, Outpatient prescriptions for five components, except Ranitidine, of H2 receptor antagonists such as Famotidine, Laputidine, Nizatidine, Cimetidine, and Roxatidine, were ￦10 billion.

 

The prescription size soared 69.5% from August before the occurrence of impurities.

 

The growth of Famotidine and Laputidine was steep.

 

In December of last year, the prescription scale of the single component of Famotidine was ￦3.1 billion, more than three times higher than in August.

 

The size of prescription for Famotidine last year was ￦17.5 billion, an increase of 38.0% compared to the previous year.

 

In December last year, the amount of outpatient prescription for Lafutidine increased by 131.8% from August to ￦3 billion.

 

As the prescription size of Famotidine and Laputidine expanded due to the reflex profit from the withdrawal of Ranitidine, pharmaceutical companies’ market activity was also active.

 

Trends in monthly outpatient prescriptions by component of major H2 receptor antagonists (Unit: ￦1 million, Source: UBIST)

Other drugs with similar uses to Ranitidine have also seen a significant increase in the number of generics.

 

In the case of Esomeprazole 20mg (generic for Nexium) increased 16 from 108 to 124 on the benefit list in September.

 

Esomeprazole is a proton pump inhibitor (PPI) -based drug and is most often used as an anti-ulcer agent.

 

Esomeprazole also enjoyed the Ranitidine reflex benefit.

 

Esomeprazole's prescription amount last year was ￦189.3 billion, up 17.1% from the previous year.

 

Esomeprazole's prescription amount increased 20.6% from ￦15.1 billion in September last year to ￦18.2 billion in one month.

 

In December of last year, it exceeded ￦20 billion.

 

September 2019 and April 2020 Artemisia Princeps 90mg Health Insurance Benefits Registered (Unit: pcs, Source: the HIRA)

The number of generics participating in the gastritis treatment Stillen market is also on the rise.

 

Stillen is a gastritis treatment with 'Artemisia Princeps' as an active ingredient.

 

Last year, the prescription size of Artemisia Princeps increased by 17.4% from the previous year to ￦87.5 billion.

 

In September of last year, 15 Artemisia Princeps 90mg products were listed, which rose 73% to 26 in 7 months.

 

The industry also complains that the government has been pushing the generics market for alternative medicines as a result of strong measures against impurity medicines.

 

All products of Ranitidine have been discontinued in Korea, while pharmaceutical manufacturers have recovered their products by lot number in the US and Europe.

 

The domestic market containing Ranitidine is about ￦200 billion per year.

 

It is a reality that pharmaceutical companies that have suffered losses due to the sale of Ranitidine have a strategy to make up for other products.

 

An industry insider said, “Excluding all products that have not been found to be harmful to the human body, considerable losses were inevitable and forced to compete in similar markets to make up for the losses”.

 

The US Food and Drug Administration (FDA) issued a statement in November last year that "the hazards of NDMA detected in Ranitidine are comparable to those exposed when eating roasted or smoked meat".

 

An official from a pharmaceutical company criticized, "The ban on the sale of all Ranitidine products in Korea also caused an excessive number of generics".