Generic for Godex development has come to an all-stop

Generics' BA secured and R&D halted due to reduced margins due to drug price cuts

Due to the same issue, Celltrion Pharmaceuticals seems unlikely to expand its tablet lineup

As pharmaceutical companies preparing to release generics for Godex announced that they would give up development, Celltrion Pharm is expected to dominate.

 

According to the industry, about three pharmaceutical companies have been identified that are preparing generics for Godex, but drug development has been suspended due to development difficulties/declining product margins.

 

Reasons for stopping the release of generics can be roughly divided into difficulties in 'registering DMF' and 'securing bioequivalence', as well as rising costs following continued drug price cuts.

 

In the meantime, the price of Godex is currently listed at 312 won after going through ten price cuts from 422 won at the time of permission in 2009.

 

When a generic is released, the drug price will drop to W166, which could significantly lower margins to 144 won, the price of Nissel for a single Pharmaking BDD.

 

Godex contains Biphenyl Dimethyl Dicarboxylate/BDD 25mg as the main ingredient, Carnitine Orotate 150mg, Adenine Hydrochloride 2.5mg, Antitoxic Liver Ext.

 

12.5mg, Cyanocobalamin 125μg, Pyridoxine Hydrochloride 25mg, and Riboflavin.

 

In addition, it is observed that the biggest obstacle is the certification and confirmation of the drug substance registration (DMF) of Antitoxic Liver Ext., one of Godex.

 

Except for some injections, DMF registration has been made mandatory for drug substances used in all medicines since 2017.

 

In the case of Antitoxic Liver Ext., which is extracted from cow liver, DMF is not registered, so generic companies have to bear the burden of proving it by investing a huge amount of money.

 

According to what is known, Celltrion Pharmaceuticals, the original developer, also has different laws and regulations at the time of product development and approval.

 

If the lineup is expanded to tablets (pills) following existing capsules, DMF registration is required, making it difficult to launch new products with the same ingredients.

 

the situation that might be possible.

 

Meanwhile, BDD, the main component of Godex, is known to have been first developed by China's LIU in 1982.

 

There is Pharmaking Nissel for BDD single drug and Pharmaking Pennel for a combination.

 

The first company to launch a BDD single ingredient in Korea was Taerim Pharmaceutical, which changed its name to Pharmaking in 2005.

 

Godex, which obtained permission in January 2000, is a blockbuster drug with 70 billion prescriptions as a 7-drug complex with 25mg of BDD as the main ingredient, the same as Nissel Pennel.

 

BDD, the main component of Godex·Nissel·Pennel, rapidly lowers GPT, the level of liver inflammation, through antioxidant action, normalizes ALT level, and reduces the rebound phenomenon in which ALT rises again when medication is discontinued.