FDA Grants Extra Patent Time for CRENESSITY: Generics Beware!
Published Date: 2/13/2026
Notice
Summary
The FDA has officially set the review period for CRENESSITY, a new drug, so its patent can be extended. This helps the drug maker get extra time to protect their invention, which could affect when generic versions hit the market. If anyone thinks the dates are wrong or wants to challenge the drug maker’s speed during review, they have until April 14 or August 12, 2026, to speak up.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA Sets Patent Review Period Length
FDA determined the regulatory review period for CRENESSITY is 2,884 days total: 2,655 days in the testing phase and 229 days in the approval phase. The testing phase began January 22, 2017, the new drug application was submitted April 29, 2024, and the application was approved December 13, 2024. In its patent extension filings the applicant seeks 355, 596, or 820 days of patent term extension.
CRENESSITY Approved For Children & Adults
The FDA approved CRENESSITY (crinecerfont) as an adjunctive treatment to glucocorticoid replacement to control androgens for adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia. This approval was granted on December 13, 2024 and is linked in the regulatory review timeline used for patent extension calculations.
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Key Dates
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