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  • Chong Kun Dang is approved for its Jardiance Duo latecomer
  • by Lee, Tak-Sun | translator Alice Kang | Nov 16, 2021 05:52am
Receives first generic exclusivity by satisfying all the conditions: first to file patent suit ; approved for the claim; and first to apply for approval
Other companies also busy preparing latecomers¡¦ substance patent for the original will expire in March 2025
Chong Kun Dang became the first to receive approval for its latecomer of the SGLT-2 inhibitor combination drug for diabetes, ¡®Jardiance Duo (empagliflozin-metformin hydrochloride).

In addition, the company received the first generic exclusivity provided to companies that succeed challenging the original patent and be the first to apply for approval.

On the 12th, the Ministry of Food and Drug Safety approved three doses of the ¡®Chong Kun Dang Empagliflozin Metformin Tablet.¡¯

The product is a combination of metformin hydrochloride and empagliflozin L-proline. Unlike the existing Jardiance Duo, Chong Kun Dang¡¯s product has added an amino acid, L-proline to its
Empagliflozin.

Chong Kun Dang has also us
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