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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Chubb
US Department of Justice
Julphar
Baxter
Colorcon
Mallinckrodt
Cantor Fitzgerald
Chinese Patent Office
Cipla

Generated: September 22, 2017

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. Seventy suppliers are listed for this compound. Additional details are available on the acetaminophen profile page.

Summary for NDA: 022450

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Formulation / Manufacturing:see details

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 43825-102-01 24 VIAL, GLASS in 1 CARTON (43825-102-01) > 100 mL in 1 VIAL, GLASS
OFIRMEV
acetaminophen
SOLUTION;IV (INFUSION) 022450 NDA Mallinckrodt Hospital Products Inc. 43825-102 43825-102-03 24 BAG in 1 CARTON (43825-102-03) > 100 mL in 1 BAG

Summary 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:Jan 27, 2020
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Jul 27, 2020
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:► SubscribePatent Expiration:Feb 5, 2018Product Flag?Substance Flag?Delist Request?Y


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Serving 500+ biopharmaceutical companies globally:

Medtronic
McKinsey
Daiichi Sankyo
US Army
Teva
Baxter
Merck
Chinese Patent Office
Cantor Fitzgerald
Accenture

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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