Hanmi obtains generic exclusivity for Dapalon Duo

By Lee, Hye-Kyung | translator Alice Kang

22.06.17 06:18:13

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4 strengths were all approved following Chong Kun Dang’s approval… 53 marketing approvals and generic exclusivity for 12 items were granted in total

Hanmi Pharmaceutical obtained generic exclusivity rights for its SGLT-2 antidiabetic combination drug ‘Dapalon Duo SR Tab (Dapagliflozin Bis L-proline/ Metformin Hydrochloride),’ a generic version of ‘Xiguo XR Tab (Dapagliflozin Propanediol Hydrate/ Metformin Hydrochloride).

The Ministry of Food and Safety recently granted marketing authorizations for the four strengths of Dapalon Duo - Dapalon Duo 5/500mg, 10/500mg, 5/1000mg, and 10/1000mg.

Its original drug is AstraZeneca’s Xiguo XR Tab, and Hanmi is the second company to receive first generic exclusivity for its four strengths after Chong Kun Dang.

The generic exclusivity will be in effect from April 8th, 2023 to J

Lee, Hye-Kyung(hgrace7@dailypharm.com)

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