Details for New Drug Application (NDA): 215760
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NDA 215760 describes CUVRIOR, which is a drug marketed by Orphalan and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the CUVRIOR profile page.
The generic ingredient in CUVRIOR is trientine tetrahydrochloride. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trientine tetrahydrochloride profile page.
The generic ingredient in CUVRIOR is trientine tetrahydrochloride. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trientine tetrahydrochloride profile page.
Summary for 215760
| Tradename: | CUVRIOR |
| Applicant: | Orphalan |
| Ingredient: | trientine tetrahydrochloride |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215760
Generic Entry Date for 215760*:
Constraining patent/regulatory exclusivity:
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: 215760
| Mechanism of Action | Copper Chelating Activity Metal Chelating Activity |
Suppliers and Packaging for NDA: 215760
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CUVRIOR | trientine tetrahydrochloride | TABLET;ORAL | 215760 | NDA | Orphalan SA | 81802-001 | 81802-001-72 | 9 CARTON in 1 CARTON (81802-001-72) / 1 BLISTER PACK in 1 CARTON (81802-001-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Apr 28, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 28, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Apr 28, 2029 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH STABLE WILSON’S DISEASE WHO ARE DE-COPPERED AND TOLERANT TO PENICILLAMINE | ||||||||
| Patent: | 10,988,436 | Patent Expiration: | May 3, 2039 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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