Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 90

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 90
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 changes to a previously approved drug product, such as a new dosage form, route of administration,
combination or indication. The three-year exclusivity covers only the conditions of use associated with the new clinical investigations
and does not prohibit the FDA from approving follow-on applications for drugs containing the original active agent. Five-year and three-year
exclusivity also will not delay the submission or approval of a traditional NDA filed under Section 505(b)(1) of the FDCA. However, an
applicant submitting a traditional NDA would be required to either conduct or obtain a right of reference to all of the preclinical studies
and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

24

Hatch-Waxman Patent Certification and the 30-Month
Stay

Upon approval of an NDA or a supplement thereto,
NDA sponsors are required to list with the FDA each patent with claims that cover the applicant’s product or an approved method
of using the product. Each of the patents listed by the NDA sponsor is published in the Orange Book. When an ANDA applicant files its
application with the FDA, the applicant is required to certify to the FDA concerning any patents listed for the reference product in the
Orange Book, except for patents covering methods of use for which the ANDA applicant is not seeking approval. To the extent that the Section
505(b)(2) NDA applicant is relying on studies conducted for an already approved product, the applicant is required to certify to the FDA
concerning any patents listed for the approved product in the Orange Book to the same extent that an ANDA applicant would.

Specifically, the applicant must certify with respect
to each patent that:

●the required patent information has not been filed by the original applicant;

●the listed patent has expired;

●the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or

●the listed patent is invalid, unenforceable or will not be infringed by the manufacture, use or sale of the new product.

If a Paragraph I or II certification is filed,
the FDA may make approval of the application effective immediately upon completion of its review. If a Paragraph III certification is
filed, the approval may be made effective on the patent expiration date specified in the application, although a tentative approval may
be issued before that time. If an application contains a Paragraph IV certification, a series of events will be triggered, the outcome
of which will determine the effective