OFIRMEV Drug Patent Profile

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When do Ofirmev patents expire, and what generic alternatives are available?

Ofirmev is a drug marketed by Mallinckrodt Hosp and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has four patent family members in three countries.

The generic ingredient in OFIRMEV is acetaminophen. There are sixty-six drug master file entries for this compound. Ninety-six suppliers are listed for this compound. Additional details are available on the acetaminophen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ofirmev

A generic version of OFIRMEV was approved as acetaminophen by PERRIGO on February 25^th, 2000.

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Summary for OFIRMEV

International Patents:	4
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	179
Clinical Trials:	60
Patent Applications:	3,399
Drug Prices:	Drug price information for OFIRMEV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OFIRMEV
What excipients (inactive ingredients) are in OFIRMEV?	OFIRMEV excipients list
DailyMed Link:	OFIRMEV at DailyMed

Drug patent expirations by year for OFIRMEV

Recent Clinical Trials for OFIRMEV

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Beth Israel Deaconess Medical Center	Phase 3
National Institute on Aging (NIA)	Phase 3
Nevakar, Inc.	Phase 2

See all OFIRMEV clinical trials

Paragraph IV (Patent) Challenges for OFIRMEV

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OFIRMEV	Injection	acetaminophen	650 mg/65 mL (10 mg/mL)	022450	1	2024-07-31
OFIRMEV	Injection	acetaminophen	1000 mg/100 mL (10 mg/mL)	022450	1	2011-04-07

US Patents and Regulatory Information for OFIRMEV

OFIRMEV is protected by five US patents.

Patents protecting OFIRMEV

Reduced dose intravenous acetaminophen
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MODIFIED DOSING REGIMEN FOR THE REDUCTION OF FEVER

Reduced dose intravenous acetaminophen
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Patent Expiration: ⤷ Sign Up
Patented Use: MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MILD TO MODERATE PAIN

Reduced dose intravenous acetaminophen
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Patent Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for OFIRMEV

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010	⤷ Sign Up	⤷ Sign Up
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for OFIRMEV

See the table below for patents covering OFIRMEV around the world.

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Country	Patent Number	Title	Estimated Expiration
Mexico	PA03000001	NUEVO METODO PARA OBTENER FORMULACIONES ACUOSAS CON PRINCIPIOS ACTIVOS SUSCEPTIBLES A OXIDACION Y LAS SOLUCIONES ACUOSAS OBTENIDAS DE ESTE MODO. (METHOD FOR OBTAINING AQUEOUS FORMULATIONS OF OXIDATION-SENSITIVE ACTIVE PRINCIPLES.)	⤷ Sign Up
European Patent Office	0858329	NOUVELLES FORMULATIONS LIQUIDES STABLES A BASE DE PARACETAMOL ET LEUR MODE DE PREPARATION (NOVEL STABLE LIQUID PARACETAMOL COMPOSITIONS, AND METHOD FOR PREPARING SAME)	⤷ Sign Up
New Zealand	523458	New method for obtaining aqueous formulations with active principles susceptible to oxidation and the aqueous solutions thus obtained	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration