Details for New Drug Application (NDA): 204958

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

The generic ingredient in KENGREAL is cangrelor. There are three drug master file entries 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
Ingredient:	cangrelor
Patents:	7

Pharmacology for NDA: 204958

Mechanism of Action	P2Y12 Receptor Antagonists
Physiological Effect	Decreased 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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Jun 22, 2015	TE:	AP	RLD:	Yes
Patent:	10,039,780	Patent Expiration:	Jul 10, 2035	Product 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:	8,680,052	Patent Expiration:	Mar 9, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD COMPRISING IV ADMINISTRATION OF CANGRELOR BEFORE PCI THEN CONTINUOUS INFUSION FOR AT LEAST 2 HOURS OR THE DURATION OF PCI AND, DURING OR AFTER CONTINUOUS INFUSION, ADMINISTRATION OF A LOADING DOSE OF TICAGRELOR, OR AN EQUIVALENT METHOD
Patent:	9,295,687	Patent Expiration:	Jul 10, 2035	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 204958

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	6,114,313	⤷ Get Started Free
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	6,130,208	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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