Details for New Drug Application (NDA): 022307

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NDA 022307 describes EFFIENT, which is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EFFIENT profile page.

The generic ingredient in EFFIENT is prasugrel hydrochloride. There are nineteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.

Summary for 022307

Tradename:	EFFIENT
Applicant:	Eli Lilly And Co
Ingredient:	prasugrel hydrochloride
Patents:	2
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022307

Mechanism of Action	P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Medical Subject Heading (MeSH) Categories for 022307

Platelet Aggregation Inhibitors

Suppliers and Packaging for NDA: 022307

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307	NDA	Eli Lilly and Company	0002-5121	0002-5121-30	30 TABLET, FILM COATED in 1 BOTTLE (0002-5121-30)
EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307	NDA	Eli Lilly and Company	0002-5121	0002-5121-52	24 BLISTER PACK in 1 CARTON (0002-5121-52) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0002-5121-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jul 10, 2009	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Jan 12, 2020
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:	Jul 12, 2019
Regulatory Exclusivity Use:	UPDATES TO THE PRODUCT LABELING BASED ON THE RESULTS OF STUDY H7T-MC-TADO TITLED, 'A PHASE 3 DOUBLE-BLIND, RANDOMIZED, MULTICENTER, EFFICACY AND SAFETY STUDY OF PRASUGREL COMPARED TO PLACEBO IN PEDIATRIC PATIENTS WITH SICKLE CELL DISEASE'
Patent:	➤ Try a Free Trial	Patent Expiration:	Jul 2, 2023	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022307

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eli Lilly And Co	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009	➤ Try a Free Trial	➤ Try a Free Trial
Eli Lilly And Co	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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