Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 88

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 88
---
 our currently owned or licensed patents to add patent life beyond their current expiration date,
depending on the expected length of clinical trials and other factors involved in the submission of the relevant NDA.

23

Abbreviated NDAs for Generic Drugs

In 1984, with passage of the Hatch-Waxman Act,
which established an abbreviated regulatory scheme authorizing the FDA to approve generic drugs based on an innovator or “reference”
product, Congress also enacted Section 505(b)(2) of the FDCA, which provides a hybrid pathway combining features of a traditional NDA
and a generic drug application. To obtain approval of a generic drug, an applicant must submit an Abbreviated New Drug Application (“ANDA”)
to the agency. In support of such applications, a generic manufacturer may rely on the preclinical and clinical testing previously conducted
for a drug product previously approved under an NDA, known as the reference listed drug (“RLD”).

Specifically, in order for an ANDA to be approved,
the FDA must find that the generic version is identical to the RLD with respect to the active ingredients, the route of administration,
the dosage form, and the strength of the drug. At the same time, the FDA must also determine that the generic drug is “bioequivalent”
to the innovator drug. Under the statute, a generic drug is bioequivalent to an RLD if “the rate and extent of absorption
of the drug do not show a significant difference from the rate and extent of absorption of the listed drug.”

Upon approval of an ANDA, the FDA indicates whether
the generic product is “therapeutically equivalent” to the RLD in its publication Approved Drug Products with Therapeutic
Equivalence Evaluations, also referred to as the Orange Book. Clinicians and pharmacists consider a therapeutic equivalent generic drug
to be fully substitutable for the RLD. In addition, by operation of certain state laws and numerous health insurance programs, the FDA’s
designation of therapeutic equivalence often results in substitution of the generic drug without the knowledge or consent of either the
prescribing clinicians or patient.

In contrast, Section 505(b)(2) permits the filing
of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for
which the applicant has not obtained a right of reference. Section 505(b)(2) NDAs may provide an alternate path to FDA approval for new
or improved formulations or new uses of