Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 147

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 147
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 is no patent information listed in the
FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) with respect to our
NDA for the applicable approved product candidate; (2) the patents listed in the Orange Book have expired; (3) the listed patents
have not expired, but will expire on a particular date and approval is sought after patent expiration; or (4) the listed patents
are invalid or will not be infringed by the manufacture, use or sale of the third party’s generic product. A certification under
21 CFR § 314.94(a)(12)(i)(A)(4) that the new product will not infringe the Orange Book-listed patents for the applicable
approved product candidate, or that such patents are invalid, is called a paragraph IV certification. If the third party submits
a paragraph IV certification to the FDA, a notice of the paragraph IV certification must also be sent to us once the third party’s
ANDA is accepted for filing by the FDA. We may then initiate a lawsuit to defend the patents identified in the notice. The filing
of a patent infringement lawsuit within 45 days of receipt of the notice automatically prevents the FDA from approving the third
party’s ANDA until the earliest of 30 months or the date on which the patent expires, the lawsuit is settled, or the court
reaches a decision in the infringement lawsuit in favor of the third party. If we do not file a patent infringement lawsuit within the
required 45-day period, the third party’s ANDA will not be subject to the 30-month stay of FDA approval.

Moreover, a third party may challenge the current patents, or patents
that may issue in the future, within our portfolio, which could result in the invalidation of some or all of the patents that might otherwise
be eligible for listing in the Orange Book for one of our products. If a third party successfully challenges all of the patents that might
otherwise be eligible for listing in the Orange Book for one of our products before an ANDA or 505(b)(2) NDA is filed we will be
unable to obtain a 30-month stay of FDA approval of a 505(b)(2) or ANDA.

For biologics, the BPCIA provides a mechanism for one or more third
parties to seek FDA approval to manufacture or sell a biosimilar or interchangeable versions of brand