Details for New Drug Application (NDA): 218808
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NDA 218808 describes CRENESSITY, which is a drug marketed by Neurocrine and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the CRENESSITY profile page.
The generic ingredient in CRENESSITY is crinecerfont. One supplier is listed for this compound. Additional details are available on the crinecerfont profile page.
The generic ingredient in CRENESSITY is crinecerfont. One supplier is listed for this compound. Additional details are available on the crinecerfont profile page.
Summary for 218808
| Tradename: | CRENESSITY |
| Applicant: | Neurocrine |
| Ingredient: | crinecerfont |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218808
Generic Entry Date for 218808*:
Constraining patent/regulatory exclusivity:
ADJUNCTIVE TREATMENT TO GLUCOCORTICOID REPLACEMENT TO CONTROL ANDROGENS IN ADULTS AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER WITH CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 218808
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CRENESSITY | crinecerfont | CAPSULE;ORAL | 218808 | NDA | Neurocrine Biosciences, Inc. | 70370-5025 | 70370-5025-1 | 60 CAPSULE in 1 BOTTLE (70370-5025-1) |
| CRENESSITY | crinecerfont | CAPSULE;ORAL | 218808 | NDA | Neurocrine Biosciences, Inc. | 70370-5050 | 70370-5050-1 | 60 CAPSULE in 1 BOTTLE (70370-5050-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Dec 13, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 13, 2031 | ||||||||
| Regulatory Exclusivity Use: | ADJUNCTIVE TREATMENT TO GLUCOCORTICOID REPLACEMENT TO CONTROL ANDROGENS IN ADULTS AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER WITH CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) | ||||||||
| Regulatory Exclusivity Expiration: | Dec 13, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jan 21, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) | ||||||||
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