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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Queensland Health
Colorcon
Farmers Insurance
Daiichi Sankyo
McKesson
Teva
US Army
UBS

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022450

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NDA 022450 describes OFIRMEV, which is a drug marketed by Mallinckrodt Ip and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OFIRMEV profile page.

The generic ingredient in OFIRMEV is acetaminophen. There are sixty-six drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the acetaminophen profile page.
Summary for 022450
Tradename:OFIRMEV
Applicant:Mallinckrodt Ip
Ingredient:acetaminophen
Patents:4
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 022450
Suppliers and Packaging for NDA: 022450
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OFIRMEV acetaminophen SOLUTION;IV (INFUSION) 022450 NDA Mallinckrodt Hospital Products Inc. 43825-102 N 43825-102-01
OFIRMEV acetaminophen SOLUTION;IV (INFUSION) 022450 NDA Mallinckrodt Hospital Products Inc. 43825-102 N 43825-102-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength1GM/100ML (10MG/ML)
Approval Date:Nov 2, 2010TE:APRLD:Yes
Regulatory Exclusivity Expiration:Jul 27, 2020
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Jan 27, 2020
Regulatory Exclusivity Use:REVISIONS TO THE PACKAGE INSERT BASED ON DATA FROM A RANDOMIZED, PLACEBO CONTROLLED, MULTICENTER STUDY OF INTRAVENOUS ACETAMINOPHEN FOR THE TREATMENT OF ACUTE PAIN IN PEDIATRIC PATIENTS TO FULFILL THE POST-MARKETING REQUIREMENT 1704-1
Patent:➤ Sign UpPatent Expiration:Feb 5, 2018Product Flag?Substance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Moodys
Deloitte
Medtronic
Cerilliant
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Johnson and Johnson
Julphar

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