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Last Updated: July 10, 2020

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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 six patents protecting this drug. Additional details are available on the PARSABIV profile page.

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
Applicant:Kai Pharms Inc
Generic Entry Opportunity Date for 208325
Generic Entry Date for 208325*:
Constraining patent/regulatory exclusivity:

*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
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:RXDosage:SOLUTION;INTRAVENOUSStrength2.5MG/0.5ML (2.5MG/0.5ML)
Approval Date:Feb 7, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 7, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Jun 27, 2034Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jul 29, 2030Product Flag?YSubstance Flag?YDelist Request?

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