Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 187

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 187
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 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:

| I. | the required patent information has not been filed by the original applicant; |

| II. | the listed patent has expired; |

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

| IV. | the listed patent is invalid, unenforceable or will not be infringed by 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 date of approval of the ANDA