Details for New Drug Application (NDA): 214133
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NDA 214133 describes RECORLEV, which is a drug marketed by Strongbridge and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the RECORLEV profile page.
The generic ingredient in RECORLEV is levoketoconazole. One supplier is listed for this compound. Additional details are available on the levoketoconazole profile page.
The generic ingredient in RECORLEV is levoketoconazole. One supplier is listed for this compound. Additional details are available on the levoketoconazole profile page.
Summary for 214133
| Tradename: | RECORLEV |
| Applicant: | Strongbridge |
| Ingredient: | levoketoconazole |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214133
Generic Entry Date for 214133*:
Constraining patent/regulatory exclusivity:
FOR TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULT PATIENTS WITH CUSHING'S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE Dosage:
TABLET;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.
Pharmacology for NDA: 214133
Suppliers and Packaging for NDA: 214133
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RECORLEV | levoketoconazole | TABLET;ORAL | 214133 | NDA | Xeris Pharmaceuticals, Inc. | 72065-003 | 72065-003-01 | 50 TABLET in 1 BOTTLE (72065-003-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Dec 30, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 30, 2028 | ||||||||
| Regulatory Exclusivity Use: | FOR TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULT PATIENTS WITH CUSHING'S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE | ||||||||
| Regulatory Exclusivity Expiration: | Dec 30, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT). | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jan 10, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN PATIENTS WITH CUSHING’S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE | ||||||||
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