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

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 25
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 invalid or would not be infringed. If the patent owner
brings a patent infringement lawsuit against the ANDA applicant within 45 days of the Paragraph IV Notification, FDA approval of the ANDA
will be automatically stayed for 30 months, or until 7-1/2 years after the NDA approval if the generic application was filed between 4
years and 5 years after the NDA approval. Any such stay will be terminated earlier if the court rules that the patent is invalid or would
not be infringed.

Competition that our products may face from generic
versions of our products could materially and adversely impact our future revenue, profitability and cash flows and substantially limit
our ability to obtain a return on the investments we have made in those product candidates.

If we fail to obtain or maintain Orphan Drug exclusivity for BIV201, we will have to rely on other potential marketing exclusivity, and on our intellectual property rights, which may reduce the length of time that we can prevent competitors from selling generic versions of BIV201.

We have obtained Orphan Drug Designation for BIV201
(terlipressin) in the U.S. for the treatment of hepatorenal syndrome on November 21, 2018 and treatment of ascites due to all etiologies
except cancer on September 8, 2016. Under the Orphan Drug Act, the FDA may designate a product as an Orphan Drug if it is a drug intended
to treat a rare disease or condition, defined, in part, as a patient population of fewer than 200,000 in the U.S. In the European Union
(“EU”), Orphan Drug designation may be granted to drugs intended to treat, diagnose or prevent a life-threatening or chronically
debilitating disease having a prevalence of no more than five in 10,000 people in the EU, and which meet other specified criteria. The
company that first obtains FDA approval for a designated Orphan Drug for the associated rare disease may receive a seven-year period of
marketing exclusivity during which time FDA may not approve another application for the same drug for the same orphan disease or condition.
Orphan Drug Exclusivity does not prevent FDA approval of another application for the same drug for a different disease or condition, or
of an application for a different drug for the same rare disease or condition. Orphan Drug exclusive marketing rights may be lost under
several circumstances, including a later determination by the FDA that the request for designation was