Details for New Drug Application (NDA): 215760
✉ Email this page to a colleague
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: | ⤷ Sign Up | Patent Expiration: | May 3, 2039 | Product Flag? | Substance Flag? | Y | Delist Request? |
Complete Access Available with Subscription