FDA Announces Regulatory Review Period for NGENLA Patent Extension
May 10, 2025
May 10, 2025
WASHINGTON, May 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has determined the regulatory review period for NGENLA (somatrogon-ghla), a human biologic product, which is eligible for patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984.
The determination was made following applications for patent term restoration filed with the U.S. Patent and Trademark Office (USPTO) by OPKO Biologics Ltd . . .
The determination was made following applications for patent term restoration filed with the U.S. Patent and Trademark Office (USPTO) by OPKO Biologics Ltd . . .