Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 133

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 133
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 drug designation qualifies a company
for tax credits and market exclusivity for seven years following the date of the product’s marketing approval if granted by
the FDA. An application for designation as an orphan product can be made any time prior to the filing of an application for approval
to market the product. If orphan drug designation is granted by the FDA, the generic identity of the therapeutic agent and its potential
orphan use are disclosed publicly by the FDA. After FDA grants orphan designation, the product must then go through the review and approval
process like any other product.

A sponsor may request orphan drug designation
of a previously unapproved product or new orphan indication for an already marketed product. In addition, a sponsor of a product that
is otherwise the same product as an already approved orphan drug may seek and obtain orphan drug designation for the subsequent product
for the same rare disease or condition if it can present a plausible hypothesis that its product may be clinically superior to the first
drug. More than one sponsor may receive orphan drug designation for the same product for the same rare disease or condition, but each
sponsor seeking orphan drug designation must file a complete request for designation.

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If a product with orphan designation 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 drug exclusivity. Orphan drug exclusivity
means that the FDA may not approve another sponsor’s marketing application for the same product for the same indication for seven years,
except in certain limited circumstances. If a product designated as an orphan drug ultimately receives marketing approval for an indication
broader than what was designated in its orphan drug application, it may not be entitled to exclusivity. Orphan drug exclusivity does
not prevent the FDA from approving a different drug for the same disease or condition, or the same drug for a different disease or condition.

The period of exclusivity begins on the date that the marketing
application is approved by the FDA and applies only to the indication for which the product has been designated. The FDA may approve
a second application for the same product for a different use or a second application for a clinically superior version of the product
for the same use. The FDA cannot, however, approve the same product made by another manufacturer for the same indication during the market
exclusivity period unless it has the consent of the sponsor, or the sponsor is unable