[Exclusive] Generic version of Celltrion's liver drug 'Godex Cap.' unavailable until 2039

(Godex Cap. / Photo from Celltrion Pharm official webpage)

By Seyoung Moon

It was revealed belatedly that Celltrion’s liver drug “Godex Cap.,” which was known to have come off patent three years ago, actually goes off patent in 2039. However, the Ministry of Food and Drug Safety (MFDS) has introduced the drug as an “off-patent drug without an approved generic,” raising the possibility of controversy.

According to Celltrion Pharm, Tuesday, the patent on “antitoxic liver ext.” -- one of seven substances composing Godex Cap. -- is still valid. Antitoxic liver ext. is a substance extracted from cattle livers. In 2019, Celltrion Pharm obtained a patent on its method for producing the substance, calling it “liver hydrolysates.” The patent is valid until 2039.

Since the patent only protects the “production method,” it is theoretically possible to produce the drug in a different way. However, industry analysts say it is virtually impossible. For that reason, Celltrion Pharm was able to extend the term of patent on Godex Cap. for 20 more years by obtaining an additional patent on the method for producing the main substance in 2019 -- the year the drug was initially supposed to go off patent.

Last year, the annual output of Godex Cap. was worth around 73.7 billion won ($57 million), and over 119.8 billion won worth of health insurance claims were filed domestically due to the drug.

The problem is that the MFDS listed Godex Cap. among “off-patent drugs without an approved generic.”

In response, the ministry explained that it “only considered patents on substances, composites, dosage forms and medical purposes, without considering patents on manufacturing processes.”

Celltrion Pharm explained that “the patent protects the method for producing liver hydrolysates of cattle and pigs under a certain condition.” “It was intended for our potential development of other products using liver hydrolysates of cattle and pigs, rather than for the extension of Godex Cap.’s patent term,” it said.

*This was translated from the article originally written in Korean. For more accurate information, please refer to the original version by using the link below. In case of discrepancies between the two versions, the Korean version shall prevail.

https://biz.sbs.co.kr/article/20000068958

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