Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 24

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 24
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omes 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 (“NCE”). An NCE is an active ingredient
that has not previously been approved by FDA in any other NDA. Specifically, in cases where such exclusivity has been granted, an ANDA
may not be submitted to the FDA until the expiration of five years unless the submission is accompanied by a Paragraph IV certification
that a patent covering the reference listed drug is either invalid or will not be infringed by the generic product, in which case the
applicant may submit its application four years following approval of the reference listed drug. If an ANDA is submitted to FDA with a
Paragraph IV Certification, the generic applicant must also provide a “Paragraph IV Notification” to the holder of the NDA
for the RLD and to the owner of the listed patent(s) being challenged by the ANDA applicant, providing a detailed written statement of
the basis for the ANDA applicant’s position that the relevant patent(s) is