Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 89

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 89
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 previously approved products; for example, an 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.
A Section 505(b)(2) applicant may eliminate the need to conduct certain preclinical or clinical studies, if it can establish that reliance
on studies conducted for a previously approved product is scientifically appropriate. Unlike the ANDA pathway used by developers of bioequivalent
versions of innovator drugs, which does not allow applicants to submit new clinical data other than bioavailability or bioequivalence
data, the 505(b)(2) regulatory pathway does not preclude the possibility that a follow-on applicant would need to conduct additional clinical
trials or nonclinical studies. The FDA may then approve the new product for all or some of the label indications for which the RLD has
been approved, or for any new indication sought by the Section 505(b)(2) applicant as applicable.

In addition, under the Hatch-Waxman Amendments,
the FDA may not approve an ANDA or 505(b)(2) NDA until any applicable period of non-patent exclusivity for the RLD has expired. These
market exclusivity provisions under the FDCA also can delay the submission or the approval of certain applications. The FDCA provides
a period of five years of non-patent data exclusivity for a new drug containing a new chemical entity (“NCE”). For the purposes
of this provision, an NCE, is a drug that contains no active moiety that has previously been approved by the FDA in any other NDA. An
active moiety is the molecule or ion responsible for the physiological or pharmacological action of the drug substance. In cases where
such NCE exclusivity has been granted, an ANDA or 505(b)(2) NDA may not be filed with the FDA until the expiration of five years unless
the submission is accompanied by a Paragraph IV certification (described below), in which case the applicant may submit its application
four years following the original product approval.

The FDCA also provides for a period of three years
of exclusivity for an NDA, 505(b)(2) NDA or supplement thereto if one or more new clinical investigations, other than bioavailability
or bioequivalence studies, that were conducted by or for the applicant are deemed by the FDA to be essential to the approval of the application.
This three-year exclusivity period often protects