Details for New Drug Application (NDA): 208325
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The generic ingredient in PARSABIV is etelcalcetide. One supplier is listed for this compound. Additional details are available on the etelcalcetide profile page.
Summary for 208325
Tradename: | PARSABIV |
Applicant: | Kai Pharms Inc |
Ingredient: | etelcalcetide |
Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208325
Generic Entry Date for 208325*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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: 208325
Mechanism of Action | Increased Calcium-sensing Receptor Sensitivity |
Suppliers and Packaging for NDA: 208325
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325 | NDA | Amgen Inc | 55513-740 | 55513-740-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-10) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01) |
PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325 | NDA | Amgen Inc | 55513-741 | 55513-741-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55513-741-10) / 1 mL in 1 VIAL, SINGLE-DOSE (55513-741-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 2.5MG/0.5ML (2.5MG/0.5ML) | ||||
Approval Date: | Feb 7, 2017 | TE: | RLD: | Yes | |||||
Patent: | 10,344,765 | Patent Expiration: | Jun 27, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | 11,162,500 | Patent Expiration: | Jun 27, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | 11,959,486 | Patent Expiration: | Jun 27, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT) |
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