Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022307

« Back to Dashboard

NDA 022307 describes EFFIENT, which is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from four 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. Nine 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	N	0002-5121-30
EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307	NDA	Eli Lilly and Company	0002-5121	N	0002-5121-52

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:	➤ Sign Up	Patent Expiration:	Jul 2, 2023	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022307

This preview shows a limited data set. Subscribe for full access, or try a Free Trial
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	➤ Sign Up	➤ Sign Up
Eli Lilly And Co	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.