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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

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 one supplier. 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. Twelve 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:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 022307
Mechanism of ActionP2Y12 Receptor Antagonists
Physiological EffectDecreased Platelet Aggregation
Medical Subject Heading (MeSH) Categories for 022307
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)
Paragraph IV (Patent) Challenges for 022307
Tradename Dosage Ingredient NDA Submissiondate
EFFIENT TABLET;ORAL prasugrel hydrochloride 022307 2013-07-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 10, 2009TE:ABRLD: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'

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 10, 2009TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jan 12, 2020
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Expired US Patents for NDA 022307

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

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