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Last Updated: December 5, 2019

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
Mechanism of ActionCyclooxygenase Inhibitors
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 55292-122-52 3 VIAL in 1 CARTON (55292-122-52) > 2 mL in 1 VIAL
NEOPROFEN ibuprofen lysine INJECTABLE;INTRAVENOUS 021903 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-490 66993-490-36 3 VIAL in 1 CARTON (66993-490-36) > 2 mL in 1 VIAL
Paragraph IV (Patent) Challenges for 021903
Tradename Dosage Ingredient NDA Submissiondate
NEOPROFEN INJECTABLE;INTRAVENOUS ibuprofen lysine 021903 2010-10-01

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:  Start TrialPatent Expiration:Nov 14, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:CLOSURE OF A CLINICALLY 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:  Start TrialPatent Expiration:Nov 14, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PATENT DUCTUS ARTERIOSUS
Patent:  Start TrialPatent Expiration:Mar 20, 2021Product Flag?YSubstance Flag?YDelist Request?Y
Patented Use:CLOSURE OF A CLINICALLY 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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