Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 287

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 287
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 products. Any of our drug candidates that may achieve regulatory
approval in the future may face competition from generic products earlier or more aggressively than anticipated, depending upon how well
such approved products perform in the U.S. prescription drug market. Our ability to compete may also be affected in many cases by insurers
or other third-party payors seeking to encourage the use of generic products.

55

The
Hatch-Waxman Amendments to the FDCA authorized the FDA to approve generic drugs that are the same as drugs previously approved for marketing
under the NDA provisions of the statute pursuant to ANDAs, and also created the Section 505(b)(2) NDA pathway. An ANDA relies on the
preclinical and clinical testing conducted for a previously approved reference listed drug and must demonstrate to the FDA that the generic
drug product is identical to the RLD with respect to the active ingredients, the route of administration, the dosage form, and the strength
of the drug and also that it is “bioequivalent” to the reference listed drug. In contrast, Section 505(b)(2) enables the
applicant to rely, in part, on the FDA’s prior findings of safety and efficacy data for an existing product, or published literature,
in support of its application. Section 505(b)(2) provides an alternate path to FDA approval for new or improved formulations or new uses
of previously approved products; for example, a follow-on applicant may be seeking approval to market a previously approved drug for
new indications or for a new patient population that would require new clinical data to demonstrate safety or effectiveness. Such products,
if approved and depending upon the scope of the changes made to the reference drug, may also compete with any drug candidates for which
we receive approval.

The
FDA is prohibited by statute from approving an ANDA or 505(b)(2) NDA when certain marketing or data exclusivity protections apply to
the reference listed drug. However, if any competitor or third party is able to demonstrate bioequivalence without infringing our patents,
then such competitor or third party may then be able to gain approval of an ANDA and introduce a competing generic product onto the market.

Furthermore,
the CREATES Act established a private cause of action that permits a generic product developer to sue the brand manufacturer to compel
it to furnish necessary samples of an RLD on “commercially reasonable, market-based terms.” If generic developers request
samples of any drug candidates for which we receive marketing approval in order to conduct comparative testing to