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Generated: November 14, 2018

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Details for New Drug Application (NDA): 204958

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NDA 204958 describes KENGREAL, which is a drug marketed by Chiesi Usa Inc and is included in one NDA. It is available from two suppliers. There are ten patents protecting this drug. Additional details are available on the KENGREAL profile page.

The generic ingredient in KENGREAL is cangrelor. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the cangrelor profile page.
Summary for 204958
Tradename:KENGREAL
Applicant:Chiesi Usa Inc
Ingredient:cangrelor
Patents:10
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 204958
Generic Entry Date for 204958*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;IV (INFUSION)

*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: 204958
Mechanism of ActionP2Y12 Receptor Antagonists
Physiological EffectDecreased Platelet Aggregation
Suppliers and Packaging for NDA: 204958
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KENGREAL cangrelor POWDER;INTRAVENOUS 204958 NDA Chiesi USA, Inc. 10122-620 10122-620-10 10 VIAL, SINGLE-USE in 1 CARTON (10122-620-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (10122-620-01)
KENGREAL cangrelor POWDER;INTRAVENOUS 204958 NDA The Medicines Company 65293-003 65293-003-10 10 VIAL, SINGLE-USE in 1 CARTON (65293-003-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (65293-003-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength50MG/VIAL
Approval Date:Jun 22, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 22, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Jul 10, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF REDUCING THE RISK OF PERIPROCEDURAL MYOCARDIAL INFARCTION, AND STENT THROMBOSIS IN A PATIENT UNDERGOING PCI BY ADMINISTERING INTRAVENOUSLY 30 UG/KG BOLUS BEFORE PCI AND THEN A CONTINUOUS INFUSION
Patent:➤ Sign UpPatent Expiration:Dec 11, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:P2Y12 PLATELET INHIBITOR FOR USE AS ADJUNCT TO PERCUTANEOUS CORONARY INTERVENTION TO REDUCE RISK OF VARIOUS DISEASES/CONDITIONS IN PATIENTS NOT TREATED WITH A P2Y12 PLATELET INHIBITOR AND NOT GIVEN A GLYCOPROTEIN IIB/IIIA INHIBITOR

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