Last Updated: August 2, 2026

OFIRMEV Drug Patent Profile


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Which patents cover Ofirmev, 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-four 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 25th, 2000.

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Summary for OFIRMEV
International Patents:4
US Patents:4
Applicants:1
NDAs:1
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for OFIRMEV
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 four US patents.

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 9,610,265*PED ⤷  Start Trial Y ⤷  Start Trial
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 DISCN Yes No 10,383,834*PED ⤷  Start Trial Y ⤷  Start Trial
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 DISCN Yes No 9,987,238*PED ⤷  Start Trial Y ⤷  Start Trial
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 DISCN Yes No 9,399,012*PED ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for OFIRMEV

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

Country Patent Number Title Estimated Expiration
Canada 2705733 ACETAMINOPHENE PAR VOIE INTRAVEINEUSE EN DOSE REDUITE (REDUCED DOSE INTRAVENOUS ACETAMINOPHEN) ⤷  Start Trial
Japan 2011503198 低用量静脈内アセトアミノフェン ⤷  Start Trial
Japan 5909750 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2009064928 ⤷  Start Trial
African Regional IP Organization (ARIPO) 957 Novel stable liquid paracetamol compositions, and method for preparing same. ⤷  Start Trial
African Regional IP Organization (ARIPO) 9801223 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

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