Orange Book patent listings
Executive Summary
FDA's Office of Generic Drugs records a 36% drop in "Orange Book" patent listings since FDA's revised Waxman/Hatch regulations took effect in August 2003. The rule, which was codified in the 2003 Medicare Modernization Act, permits only one 30-month stay of approval on ANDAs (1"The Pink Sheet" Aug. 18, 2003, p. 17). For the year prior to the rule's enactment (Aug. 18, 2002 to Aug. 18, 2003), the number of distinct new listed patents was 383; for the following 12 months, listings fell to 245 patents. "It's too soon to make definitive conclusions about" MMA and the generic drug regulations, "but I can tell you that from my standpoint...they're working well," FDA Acting Commissioner Lester Crawford told the Generic Pharmaceutical Association's annual meeting...
You may also be interested in...
Ribavirin ANDAs Await ICN Petition; FDA Generic Rule Takes Effect
The delay in approval for generic versions of Schering-Plough's Rebetol (ribavirin) illustrates one limitation of FDA's revised Waxman/Hatch regulations
Like Sands Through The Hourglass, So Are Janet Woodcock’s Days As Acting FDA Commissioner
Janet Woodcock has been a no-nonsense acting commissioner, but there’s plenty of drama in the nomination process as opposition and support for her to become permanent head of the US FDA continues to mount while the wait for President Biden’s nominee drags on.
Finance Watch: Insilico Raises $255m To Take AI-Discovered Drugs Into The Clinic
Private Company Edition: Nine new venture capital mega-rounds include Insilico’s series C, $250m from Blackstone for a CAR-T therapy spinout from Intellia and a $210m series B round for Umoja.