Company: BFRG
Filing Date: 2025-03-14
Form Type: 10-K
Source: 0001493152-25-010367
Chunk: 85

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-03-14
Form: 10-K
Item: Item 1
Chunk 85
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announced inspections by the FDA, during which the Agency inspects manufacturing facilities to assess compliance with cGMPs. Accordingly,
manufacturers must continue to expend time, money, and effort in the areas of production and quality-control to maintain compliance with
cGMPs. Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with regulatory
standards, if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered.

Generic
Competition

In
seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent whose claims cover the applicant’s
product. Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA’s Approved
Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Drugs listed in the Orange Book can, in turn,
be cited by potential generic competitors in support of approval of an abbreviated new drug application (“ANDA”). An ANDA
provides for marketing of a drug product that has the same active ingredients in the same strengths and dosage form as the listed drug
and has been shown through bioequivalence testing to be therapeutically equivalent to the listed drug. Other than the requirement for
bioequivalence testing, ANDA applicants are not required to conduct, or submit results of, preclinical or clinical tests to prove the
safety or effectiveness of their drug product. Drugs approved in this way are commonly referred to as “generic equivalents”
to the listed drug and can often be substituted by pharmacists under prescriptions written for the original listed drug.

The
ANDA applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s Orange Book.
Specifically, the applicant must certify that (i) the required patent information has not been filed; (ii) the listed patent has expired;
(iii) the listed patent has not expired but will expire on a particular date and approval is sought after patent expiration; or (iv)
the listed patent is invalid or will not be infringed by the new product (a Paragraph IV certification). The ANDA applicant may also
elect to submit a section viii statement certifying that its proposed ANDA label does not contain (or carve out) any language regarding
the patented method-of-use rather than certify to a listed method-of-use patent. If the applicant does not challenge the listed patents
or certifies that the listed patents will not be infringed