Company: BIVIW
Filing Date: 2025-08-04
Form Type: S-1/A
Source: 0001520138-25-000235
Chunk: 26

Company: BIOVIE INC.
Filing Date: 2025-08-04
Form: S-1/A
Chunk 26
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 if approved, to successfully commercialize our drugs, our research
and development (“R&D”) efforts, including the timing and cost of clinical trials; and our ability to enter into favorable
alliances with third-parties who can provide substantial capabilities in clinical development, regulatory affairs, sales, marketing and
distribution.

Even if we successfully develop and market BIV201
and/or bezisterim (NE3107), we may not generate sufficient or sustainable revenue to achieve or sustain profitability, which could cause
us to cease operations and cause you to lose all of your investment.

If the FDA or comparable foreign regulatory authorities approve generic versions of any of our product candidates that receive marketing approval, or such authorities do not grant our products sufficient, or any, periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected.

Once a NDA is approved, the product covered thereby
becomes a “reference listed drug” (“RLD”), in the FDA’s publication, “Approved Drug Products with
Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. Other manufacturers may seek approval of generic versions
of reference listed drugs through submission of abbreviated new drug applications (“ANDAs”) in the United States. In support
of an ANDA, a generic manufacturer need not conduct clinical trials. Rather, the applicant generally must show that its product has the
same active ingredient(s), dosage form, strength, route of administration and conditions of use or labeling as the reference listed drug
and that the generic version is bioequivalent to the reference listed drug, meaning it is absorbed in the body at the same rate and to
the same extent as the RLD. Generic products may be significantly less costly to bring to market than the reference listed drug and companies
that produce generic products are generally able to offer them at lower prices. Moreover, generic versions of RLDs are often automatically
substituted for the RLD by pharmacies when dispensing a prescription written for the RLD. Thus, following the introduction of a generic
drug, a significant percentage of the sales of any branded product or reference listed drug is typically lost to the generic product.

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The FDA may not approve an ANDA for a generic
product until any applicable period of non-patent exclusivity for the reference listed drug has expired. The FDCA provides a period of
five years of non-patent exclusivity for a new drug containing a new chemical entity (“N