Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 185

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 185
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 ion responsible
for the action of the drug substance. In cases where such 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 (as 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 data 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 changes to a previously approved drug product, such
as a new dosage form, route of administration, combination or indication. This 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.

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 a 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:

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