Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 288

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 288
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 support one or more
ANDAs for a generic version of our products, and we refuse any such request, we may be subject to litigation under the CREATES Act. Although
lawsuits have been filed under the CREATES Act since its enactment, those lawsuits have generally settled privately there continues to
be uncertainty regarding the scope and application of the law.

Settlements and related licensing agreements resulting
from Hatch-Waxman litigation can be challenged and have the potential to generate additional litigation which can be costly. The success
of such litigation depends on the strength of the patents covering our branded products and our ability to prove that the follow-on applicant’s
product would infringe one or more such patents. The outcome of such litigation is inherently uncertain and may result in potential loss
of any market exclusivity we may receive for our drug candidates, if approved, which may have a significant financial impact on our business.
Furthermore, the FTC, has brought successful lawsuits challenging Hatch-Waxman litigation settlements as anti-competitive, and such decisions
have been upheld by federal circuit courts. If we engage in Hatch-Waxman litigation, we may also face an FTC challenge with respect to
any proposed settlement related to such litigation, which may result in additional expense or penalty. The FTC also has more recently
been questioning pharmaceutical company patent listings in the Orange Book and raising concerns about “improper” listings
that may be intended to discourage competition by follow-on drug developers, and certain members of Congress have been investigating similar
issues. Accordingly, there could be future changes to federal laws, regulations, or guidelines related to Hatch-Waxman requirements or
procedures that could have a material adverse impact on all pharmaceutical innovators, including us.

We
cannot predict the interest of potential follow-on competitors or how quickly others may seek to come to market with competing products,
whether approved as a direct ANDA competitor or as a Section 505(b)(2) NDA referencing one of our future drug candidates. If the FDA
approves generic versions of any of our products in the future, should they be approved for commercial marketing, such competitive products
may be able to immediately compete with us in each indication for which our product has received approval, which could negatively impact
our future revenue, profitability and cash flows and substantially limit our ability to obtain a return on our investments.

In addition, while we are currently exploring potential patent protection
strategies for our lead drug candidate, PSX-001, there can be no assurance that our efforts to provide intellectual property