BioPharmaceutical Business Intelligence

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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Cantor Fitzgerald
Queensland Health
Johnson and Johnson
Argus Health
US Army

Generated: September 20, 2017

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 four suppliers. There are three 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. Five suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.

Summary for NDA: 022307

Formulation / Manufacturing:see details

Pharmacology for NDA: 022307

Mechanism of ActionP2Y12 Receptor Antagonists
Physiological EffectDecreased Platelet Aggregation

Suppliers and Packaging for NDA: 022307

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 10, 2009TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jul 12, 2019
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Jan 12, 2020
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:► SubscribePatent Expiration:Oct 14, 2017Product Flag?Substance Flag?Delist Request?Y

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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Queensland Health
Fish and Richardson
Harvard Business School
Boehringer Ingelheim
Farmers Insurance

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.

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