Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 184

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 184
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 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.” Physicians 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 physician or patient.

| 92 |

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. 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; for example,
they 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. 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. A drug is a new chemical entity
if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or