2025-08255Notice

Patent Clock Ticks for LITFULO After FDA Review Period

Published Date: 5/12/2025

Notice

Summary

The FDA has officially set the review period for LITFULO, a human drug product, so its patent can be extended. This helps the drug maker get extra time to protect their invention after the long approval process. If you’re involved in drug patents or development, this means important timing updates and potential market exclusivity changes.

Analyzed Economic Effects

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

Patent Extension Eligibility Set

The FDA has determined the regulatory review period for the drug LITFULO so its patent can be extended. This lets the patent holder seek extra time to protect the invention after the drug approval process.

Timing and Exclusivity Updates for Developers

The notice provides timing updates related to LITFULO's regulatory review period and says there could be changes to the drug's market exclusivity. If you work on drug patents or development, this alerts you to important timing and exclusivity effects for LITFULO.

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Key Dates

Published Date
5/12/2025

Department and Agencies

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