Details for New Drug Application (NDA): 214018
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NDA 214018 describes NULIBRY, which is a drug marketed by Sentynl Theraps Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the NULIBRY profile page.
The generic ingredient in NULIBRY is fosdenopterin hydrobromide. One supplier is listed for this compound. Additional details are available on the fosdenopterin hydrobromide profile page.
The generic ingredient in NULIBRY is fosdenopterin hydrobromide. One supplier is listed for this compound. Additional details are available on the fosdenopterin hydrobromide profile page.
Summary for 214018
| Tradename: | NULIBRY |
| Applicant: | Sentynl Theraps Inc |
| Ingredient: | fosdenopterin hydrobromide |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214018
Generic Entry Date for 214018*:
Constraining patent/regulatory exclusivity:
INDICATED TO REDUCE THE RISK OF MORTALITY IN PATIENTS WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A Dosage:
POWDER;INTRAVENOUS |
*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: 214018
Suppliers and Packaging for NDA: 214018
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NULIBRY | fosdenopterin hydrobromide | POWDER;INTRAVENOUS | 214018 | NDA | Sentynl Therapeutics, Inc. | 42358-295 | 42358-295-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (42358-295-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 9.5MG BASE/VIAL | ||||
| Approval Date: | Feb 26, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 26, 2028 | ||||||||
| Regulatory Exclusivity Use: | INDICATED TO REDUCE THE RISK OF MORTALITY IN PATIENTS WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A | ||||||||
| Regulatory Exclusivity Expiration: | Oct 27, 2025 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION TO INCLUDE RESULTS FROM STUDY ORGN001-102 | ||||||||
| Regulatory Exclusivity Expiration: | Feb 26, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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