FDA has always regulated racemates as a single API and the constituent single isomers as different API’s. Lupin Pharmaceuticals decided to challenge this treatment and lost at the US Court of Appeals for the Federal Circuit. My friend and patent law expert, Stephen Albainy-Jenei reviewed this decision in a May 19 post, so I refer [...]
Archive for May, 2010
Enantiomers are different drugs than racemates
Published May 20th, 2010 in 505(b)(2) Issues and News Commentary. 0 CommentsPro-drug denied
Published May 19th, 2010 in 505(b)(2) Issues, 505(b)(2) Process and News Commentary. 0 CommentsI am frequently asked if 505(b)(2) projects fail or whether any NDA submissions are rejected. My answer is that the vast majority succeeds and are eventually approved. Those that fail more often are due to money or design issues, not execution risks. Today I discuss an example of a failure based, in large part, on [...]
505(b)(2) product gains revenue with FDA actions against DESI’s
Published May 19th, 2010 in 505(b)(2) Issues and News Commentary. 0 CommentsEurand reported improved financial performance for the 1st quarter of 2010. CEO Gearoid Faherty indicated the majority of the revenue gains could be attributed to Zenpep®, Eurand’s delayed-release pancreatic insufficiency drug. Zenpep was approved in August 2009. The FDA has recently clamped down on unapproved pancreatic enzymes that have been on the market for years. [...]
Target Product Profile
Published May 14th, 2010 in 505(b)(2) Process, CMC Issues and How to:. 0 CommentsToday’s blog courtesy of Lynn Gold, Ph.D. Camargo’s VP of CMC. In any project development program an understanding of the program goal is critical to finding the shortest path to the final result. Generation of a Target Product Profile early in a development program facilitates reaching the goal of a marketed drug product. It provides [...]
Active Ingredient or Active Moiety?
Published May 21st, 2010 in 505(b)(2) Issues and News Commentary. 0 CommentsWhen the pharmacological properties of an ester differ from that of the underlying acid, the ester is eligible for patent life extension. This was the conclusion reached by the U.S. Court of Appeals for the Federal Circuit in the case of Photocure ASA v. Kappos. Photocure had developed and patented aminolevulinic acid (ALA), Levulan®, approved [...]