Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 57

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 57
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 the product generally will be receiving 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. Those circumstances include instances in which another sponsor’s application for the same drug product and
indication is shown to be “clinically superior” to the previously approved drug. In this context, clinically superior means
that the drug provides a significant therapeutic advantage over and above the already approved drug in terms of greater efficacy, greater
safety or by providing a major contribution to patient care. Competitors may receive approval of different products for the indication
for which the orphan product has exclusivity and may obtain approval for the same product but for a different 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.

Under FDARA, orphan exclusivity will not bar
approval of another orphan drug under certain circumstances, including if a subsequent product with the same drug for the same indication
is shown to be clinically superior to the approved product on the basis of greater efficacy or safety, or providing a major contribution
to patient care, or if the company with orphan drug exclusivity is not able to meet market demand. The new legislation reverses prior
precedent holding that the Orphan Drug Act unambiguously required the FDA to recognize orphan exclusivity regardless of a showing of
clinical superiority.

Patent Term Restoration and Extension

A patent claiming a new drug product may be eligible
for a limited patent term extension under the Hatch-Waxman Act, which permits a patent restoration of up to five years for patent term
lost during product development and the FDA regulatory review. The restoration period granted is typically one-half the time between
the effective date of an IND and the submission date of an NDA, plus the time between the submission date of an NDA and the ultimate
approval date. Patent term restoration cannot be used to extend the remaining term of a patent past a total of 14 years from the product’s
approval date. Only one patent applicable to an approved drug product is eligible for the extension, and the application for the extension
must be submitted prior to the expiration of the patent in question. A patent that covers multiple drugs for which approval is sought
can only be extended in connection with one of the approvals. The U.S. Patent and Trademark Office