Angiomax is a single peptide with a molecular weight of about 2 KD. It is manufactured synthetically with no biologically-derived API. Making a generic copy of Angiomax is harder than making a generic for a typical small-molecule drug, but it’s much easier than making a generic for Lovenox or Copaxone.
Three companies have filed a Paragraph-IV challenge seeking to invalidate MDCO’s patents and obtain FDA approval for generic Angiomax. One of the three companies is APP Pharmaceuticals; the other two challengers are unknown.
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