Court Drops Depth Charge on Submarine Exclusivity
August 5th, 2019
On July 22, 2019, the United States District Court for the District of Columbia ruled against the Food and Drug Administration (“FDA”) in a lawsuit challenging FDA’s application of 3-year exclusivity in the context of a 505(b)(2) application. T…
Read More
Read More
Submarine Exclusivity: Unseen Risk for 505(b)(2) Applications
May 13th, 2019
Last week, the Food and Drug Administration (FDA) finalized its guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application. The final guidance provides useful tips on the differences between ANDAs and 505(b)(2) applications and the…
Read More
Read More