Gerardke schreef op 20 mei 2021 21:37:
na het lezen van de SEC filing van vandaag droom ik weer al minder : Our formulation of ZYESAMI is not covered by an existing patent and may be subject to future generic competition.
ZYESAMI is not currently covered by any US or international patent. US Patent 8178489B2 and foreign counterparts does not apply to ZYESAMI because it covers only formulations of aviptadil that are formulated in
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a buffer. Laboratory evidence suggests that Vasoactive Intestinal Peptide (aviptadil) aggregates and may be inactivated by known buffers. NeuroRx is engaged in a discovery process to extend the stability of ZYESAMI and has made certain discoveries that may lead to future patent filings and which may or may not lead to allowed patent claims. In the event that no patent protection is granted covering the formulation of ZYESAMI, if the drug is approved by FDA, it is anticipated to receive at least five years of data exclusivity from the FDA under what is commonly known as “paragraph 4” protections. Should no patents be granted by the end of this data exclusivity period, competitors may be able to market generic versions of ZYESAMI.