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Serving hundreds of leading biopharmaceutical companies globally:

UBS
AstraZeneca
QuintilesIMS
Covington
Baxter
Fish and Richardson
Dow
Argus Health
Healthtrust

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021903

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NDA 021903 describes NEOPROFEN, which is a drug marketed by Recordati Rare and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NEOPROFEN profile page.

The generic ingredient in NEOPROFEN is ibuprofen lysine. There are sixty-four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ibuprofen lysine profile page.
Summary for 021903
Tradename:NEOPROFEN
Applicant:Recordati Rare
Ingredient:ibuprofen lysine
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 021903
Suppliers and Packaging for NDA: 021903
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOPROFEN ibuprofen lysine INJECTABLE;INTRAVENOUS 021903 NDA RECORDATI RARE DISEASES, INC. 55292-122 N 55292-122-52
NEOPROFEN ibuprofen lysine INJECTABLE;INTRAVENOUS 021903 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-490 N 66993-490-36

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Approval Date:Apr 13, 2006TE:APRLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 14, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL MEDICAL MANAGEMENT IS INEFFECTIVE
Patent:➤ Sign UpPatent Expiration:Nov 14, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PATENT DUCTUS ARTERIOSUS
Patent:➤ Sign UpPatent Expiration:Mar 20, 2021Product Flag?YSubstance Flag?YDelist Request?Y
Patented Use:CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL MEDICAL MANAGEMENT IS INEFFECTIVE

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Dow
McKesson
US Army
Fish and Richardson
Covington
Johnson and Johnson
Express Scripts
Cipla

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