Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 56

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 56
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 deferrals are contained in FDASIA. Unless otherwise required by regulation, the pediatric data
requirements do not apply to products with orphan designation.

28

Pediatric exclusivity is another type of non-patent
marketing exclusivity in the United States and, if granted, provides for the attachment of an additional six months of marketing protection
to the term of any existing regulatory exclusivity, including the non-patent and orphan exclusivity. This six-month exclusivity may be
granted if an NDA sponsor submits pediatric data that fairly responds to a written request from the FDA for such data. The data do not
need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond
to the FDA’s request, additional protection is granted. If reports of requested pediatric studies are submitted to and accepted
by the FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity or patent protection cover the product
are extended by six months. This is not a patent term extension, but it effectively extends the regulatory period during which the FDA
cannot approve another application. With regard to patents, the six-month pediatric exclusivity period will not attach to any patents
for which a generic (ANDA or 505(b)(2) NDA) applicant submitted a paragraph IV patent certification, unless the NDA sponsor or patent
owner first obtains a court determination that the patent is valid and infringed by a proposed generic product.

Orphan Drug Designation and Exclusivity

Under the Orphan 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 status 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,