2025-13046Notice

ABRYSVO's Patent Review Period Locked In by FDA

Published Date: 7/14/2025

Notice

Summary

The FDA has officially set the review period for ABRYSVO, a new human biological product. This means the company can apply to extend its patent, giving them more time to protect their invention. If approved, this could affect when generic versions hit the market and impact future drug prices.

Analyzed Economic Effects

2 provisions identified: 1 benefits, 1 costs, 0 mixed.

FDA Sets Review Period for ABRYSVO

The FDA has determined the regulatory review period for ABRYSVO, a human biological product. The company submitted an application to the U.S. Patent and Trademark Office to extend a patent that claims ABRYSVO, allowing the company to seek additional time to protect its invention.

Possible Delay of Generics and Price Effects

If the patent extension for ABRYSVO is approved, it could delay when generic versions reach the market and could affect future drug prices. This change would influence when patients and buyers can access lower-cost alternatives.

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Key Dates

Published Date
7/14/2025

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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