Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 192

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 192
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 Drug Act,
the FDA may designate a drug product as an “orphan drug” if it is intended to treat a rare disease or condition (generally
meaning that it affects fewer than 200,000 individuals in the United States, or more in cases in which there is no reasonable expectation
that the cost of developing and making a drug product available in the United States for treatment of the disease or condition will be
recovered from sales of the product). A company must request orphan product designation before submitting an NDA. If the request is granted,
the FDA will disclose the identity of the therapeutic agent and its potential use. Orphan product designation does not convey any advantage
in or shorten the duration of the regulatory review and approval process.

If a product with orphan designation
subsequently receives the first FDA approval for the disease or condition for which it has such designation or for a select indication
or use within the rare disease or condition for which it was designated, the product generally will receive orphan product exclusivity.
Orphan product exclusivity means that the FDA may not approve any other applications for the same product for the same indication for
seven years, except in certain limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity
by means of greater effectiveness, greater safety or providing a major contribution to patient care or in instances of drug supply issues.
Competitors, however, may receive approval of either a different product for the same indication for which the orphan product has exclusivity
or for the same product but for a different indication (which could then be used off-label in the orphan indication). If a drug or drug
product designated as an orphan product ultimately receives marketing approval for an indication broader than what was designated in its
orphan product application, it may not be entitled to exclusivity.

Patent Term Restoration and Extension

The term of a United States
patent that covers a drug, biological product or medical device approved pursuant to a PMA may also be eligible for patent term extension
when FDA approval is granted, provided that certain statutory and regulatory requirements are met. The length of the patent term extension
is related to the length of time the product is under regulatory review while the patent is in force. The Hatch-Waxman Act permits a patent
term extension of up to five years beyond the expiration date set for the patent. However, patent extension cannot extend the remaining
term of a patent beyond a total of 14 years from the date of product approval. Only one patent applicable to an