Company: BFRG
Filing Date: 2025-03-14
Form Type: 10-K
Source: 0001493152-25-010367
Chunk: 86

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-03-14
Form: 10-K
Item: Item 1
Chunk 86
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 by the new product, the ANDA application will not be approved until all the
listed patents claiming the referenced product have expired. If the ANDA applicant has provided a Paragraph IV certification, the NDA
and patent holders may then initiate a patent infringement lawsuit in response. The filing of a patent infringement lawsuit within 45
days of the receipt of such a certification automatically prevents the FDA from approving the ANDA until the earlier of 30 months, expiration
of the patent, settlement of the lawsuit, or a decision in the infringement case that is favorable to the ANDA applicant.

Exclusivity

Upon
NDA approval of a new chemical entity (“NCE”) that drug receives five years of marketing exclusivity during which the FDA cannot receive
any ANDA seeking approval of a generic version of that drug. An ANDA may be submitted one year before NCE exclusivity expires if a Paragraph
IV certification is filed. If there is no listed patent in the Orange Book, there may not be a Paragraph IV certification, and, thus,
no ANDA may be filed before the expiration of the exclusivity period. Certain changes to a drug, such as the addition of a new indication
to the package insert, can be the subject of a three-year period of exclusivity if the application contains reports of new clinical investigations
(other than bioavailability studies) conducted or sponsored by the sponsor that were essential to approval of the application. The FDA
cannot approve an ANDA for a generic drug that includes the change during the period of exclusivity.

 20 

Patent
Term Extension

After
NDA approval, owners of relevant drug patents may apply for up to a five-year patent extension. The allowable patent term extension is
calculated as half of the drug’s testing phase (the time between IND application and NDA submission) and all of the review phase
(the time between NDA submission and approval up to a maximum of five years). The time can be shortened if the FDA determines that the
applicant did not pursue approval with due diligence. The total patent term after the extension may not exceed 14 years, and only one
patent can be extended. For patents that might expire during the application phase, the patent owner may request an interim patent extension.
An interim patent extension increases the patent term by one year and may be renewed up to four times. For each interim patent extension
granted, the post-approval patent extension is reduced by one year. The director of the United States Patent and Trademark