Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 26

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 26
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 materially defective or if the
manufacturer is unable to assure sufficient quantity of the drug. Similar regulations are available in the EU with a ten-year period of
market exclusivity.

Even though BioVie has obtained two Orphan Drug
Designations for its lead product candidate, terlipressin, for treatment of ascites and for treatment of hepatorenal syndrome, and may
seek other Orphan Drug Designations for BIV201, and Orphan Drug Designation for other product candidates, there is no assurance that BioVie
will be the first to obtain marketing approval for any particular rare indication. Further, even though BioVie has obtained Orphan Drug
Designations for its lead product candidate, or even if BioVie obtains Orphan Drug Designation for other potential product candidates,
such designation may not effectively protect BioVie from competition because different drugs can be approved for the same condition and
the same drug can be approved for different conditions and potentially used off-label in the Orphan indication. Even after an Orphan Drug
is approved, the FDA can subsequently approve another competing drug with the same active ingredient for the same condition for several
reasons, including, if the FDA concludes that the later drug is clinically superior due to being safer or more effective or because it
makes a major contribution to patient care. Orphan Drug Designation neither shortens the development time or regulatory review time of
a drug, nor gives the drug any advantage in the regulatory review or approval process.

In addition, other companies have received Orphan
Drug designations for terlipressin. Mallinckrodt Hospital Products IP Limited received Orphan Drug designation in 2004 for terlipressin
for the treatment of Hepatorenal Syndrome. Mallinckrodt has already gained FDA approval for its product, lyophilized terlipressin acetate
for bolus intravenous administration for the treatment of hepatorenal syndrome Type 1 in September 2022. PharmaIN Corporation received
Orphan Drug Designation in 2012 for PGC-C12E-terlipressin for treatment of ascites due to all etiologies except cancer. In addition, Ferring
Pharmaceuticals Inc. received Orphan Drug designation in 1986 for terlipressin for the treatment of bleeding esophageal varices. If one
of those or any other company with Orphan Drug Designation for the same drug as ours for the same proposed disease or condition receives
FDA approval