Yes, KD Pharma can because EPAspire is a free fatty acid form of EPA. Amarin only patented ethyl ester form of EPA in a capsule form factor. In fact, if AZN wants, it can further refine its EPANOVA API into the phospholipid form of pure EPA, and compete with Vascepa legally (may need additional trial data). Or anyone can make a methyl form of EPA and do a trial to benchmark with Vascepa, and if data is good, it can sell legally.
The question for them is - is it financially worthwhile to do so? All the pure EPA manufacturers (at least to my knowledge) have a step in its process, called trans-esterification which means stripping the natural glycerol ester group from all fatty acids and reattach another ester group. This is a critical step for concentrating EPA to reach a very high purity. All makers use ethanol in this step because it's a very small molecule and cheap. All of these means ethyl EPA is the cheapest pure EPA API one can get right now.
For KD Pharma to make the free fatty acid form of EPA, it has to strip the ethyl group from the ethyl EPA or Vascepa's API. That's an additional step, and hence additional cost. I don't know the specific number but 10% more is probably minimum considering the yield and process. Plus free fatty acid form of EPA is very susceptible to oxidation. It may add extra cost on shipping and handling of the EPA from API maker's site to encapsulator's site, etc.
So if Amarin keeps a "modest" price for Vascepa and its gross margin is about 60%-70% (?). That means KD Pharma has to bear a gross margin of 50% or lower to compete with Vascepa in the CVD market. Not sure this is palatable to most pharma especially if additional trial data is needed to prove free EPA performs similarly to ethyl EPA regarding CVD treatment.
