Details for New Drug Application (NDA): 211241
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NDA 211241 describes ZYCUBO, which is a drug marketed by Sentynl Theraps Inc and is included in one NDA. It is available from one supplier. Additional details are available on the ZYCUBO profile page.
The generic ingredient in ZYCUBO is copper histidinate. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the copper histidinate profile page.
The generic ingredient in ZYCUBO is copper histidinate. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the copper histidinate profile page.
Summary for 211241
| Tradename: | ZYCUBO |
| Applicant: | Sentynl Theraps Inc |
| Ingredient: | copper histidinate |
| Patents: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211241
Generic Entry Date for 211241*:
Constraining patent/regulatory exclusivity:
TREATMENT OF MENKES DISEASE IN PEDIATRIC PATIENTS Dosage:
POWDER;SUBCUTANEOUS |
*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: 211241
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZYCUBO | copper histidinate | POWDER;SUBCUTANEOUS | 211241 | NDA | Sentynl Therapeutics, Inc. | 42358-329 | 42358-329-01 | 1 VIAL, GLASS in 1 CARTON (42358-329-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | 2.9MG/VIAL | ||||
| Approval Date: | Jan 12, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 12, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jan 12, 2033 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF MENKES DISEASE IN PEDIATRIC PATIENTS | ||||||||
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