Details for New Drug Application (NDA): 208325
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NDA 208325 describes PARSABIV, which is a drug marketed by Kai Pharms Inc and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the PARSABIV profile page.
The generic ingredient in PARSABIV is etelcalcetide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the etelcalcetide profile page.
The generic ingredient in PARSABIV is etelcalcetide. There is one drug master file entry for this compound. 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 | 55513-740 | 55513-740-20 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-20) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01) |
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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