The Ministry of Food and Drug Safety said 158 pharmaceutical patents will expire in 2021, creating an environment for generic drugs to enter the market.

Among the 158, 44 patents will be readily available for generic manufacturers upon the expiry of patent periods, as no other patents are involved in their products

Fifty-one patents will be expired in the first three months of the year, 29 in the second quarter, 37 in the third, and 41 in the fourth, the ministry said.

A total of 158 pharmaceutical patents will expire in 2021, creating a favorable environment for generic drugs to enter the market.
A total of 158 pharmaceutical patents will expire in 2021, creating a favorable environment for generic drugs to enter the market.

Industry insiders are eyeing Hanmil Pharmaceutical’s hypertension therapy Amosartan and Amlopidine drugs among the products planned for patent expiration. By March 29, 14 patents related to Amosartan and Amlopidine drugs will expire. 

Hanmi Pharmaceutical is holding 30 patents related to the Amosartan series, of which 12 will expire this year. Currently, only those who have successfully designed around the patents can sell Amosartan copy drugs.

About 30 companies, including Korea United Pharm, have avoided the patent for the crystalline form of Amosartan in 2014 and the composition patent that will expire in 2036. The companies have already begun distributing Amosartan generics.

Also drawing attention is the new oral anticoagulant (NOAC) market.

The patent for Pradaxa, a NOAC developed by Boehringer Ingelheim, will be terminated on July 17. Ten drug makers that avoided formulation patent infringement, including Jeil Pharmaceutical, can release their generic drugs of Pradaxa after expiration.

Bayer’s NOAC, Xarelto, will see its patent expire in October. About 23 pharmaceutical companies, including SK Chemicals, Chong Kun Dang, and Hanmi Pharmaceutical, are waiting to launch copy drugs.

The patent applied to AstraZeneca’s hyperlipidemia treatment Crestor will expire in November. When the formulation patent was expired in August 2020, 132 generic drugs entered the market.

“We cannot disclose detailed information because of the company’s policy. For now, however, we are preparing to defend the product sales in the market as we will lose the patent rights this year,” said an official at an original drug developer.

The Korea Drug Research Association said that patent disputes always rise in releasing copy drugs when originals’ patents expire. Therefore, pharmaceutical companies that have developed original drugs register various patents in usage, dosage, and formulation.

Another pharmaceutical industry executive said, “Developers of new drugs attract attention. If there are no generic makers of the originals even after their patent expiry, however, the original drugs have little influence on the market.”

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