Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 22

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 22
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 in the United States, or a patient
population greater than 200,000 individuals in the United States when there is no reasonable expectation that the cost of developing
and making the product available in the United States for the disease or condition will be recovered from sales of the product.
Orphan drug designation must be requested before submitting a marketing application. After the FDA grants orphan drug designation,
the generic identity of the therapeutic agent and its designated orphan use are disclosed by the FDA on its website. Orphan drug
designation does not convey any advantage in or shorten the duration of the regulatory review and approval process, though companies
developing orphan products are eligible for certain incentives, including tax credits for qualified clinical testing and waiver
of application fees.

If
a product that has orphan drug designation subsequently receives the first FDA approval for the use for which it has such designation,
the product is entitled to a seven-year period of marketing exclusivity from the date of FDA approval during which the FDA may
not approve any other applications to market the “same drug” for the same use, except in limited circumstances, such
as a subsequent product’s showing of “clinical superiority” over the product with orphan exclusivity or where
the original applicant cannot produce sufficient quantities of product. The FDA defines “same drug” with respect to
small molecule drugs as a drug that contains the same active moiety as a previously approved drug and is intended for the same
use as the previously approved drug. To demonstrate a drug is “clinically superior” to the previously approved orphan
drug, a sponsor must show that the drug provides a significant therapeutic advantage over and above the previously already approved
drug in terms of greater efficacy, greater safety, or by providing a major contribution to patient care. Since the enactment of
the FDA Reauthorization Act of 2017, the FDA publishes clinical superiority findings on its website for those drugs approved on
or after August 18, 2017. Competitors, however, may receive approval of different therapeutic agents for the indication for which
the orphan product has exclusivity or obtain approval for the same therapeutic agent for a different indication than that for
which the orphan product has exclusivity. If an orphan designated product receives marketing approval for an indication broader
than what is designated, it may not be entitled to orphan exclusivity. Further, orphan drug exclusive marketing rights in the
United States may be lost if the FDA later determines that the request for designation was materially defective or the manufacturer
of the approved product is unable to assure sufficient quantities