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Last Updated: June 28, 2022

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 one Paragraph IV challenge.

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. Eighty-three suppliers are listed for this compound. Additional details are available on the acetaminophen profile page.

Drug patent expirations by year for OFIRMEV
Drug Prices for OFIRMEV

See drug prices for OFIRMEV

Recent Clinical Trials for OFIRMEV

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

SponsorPhase
Beth Israel Deaconess Medical CenterPhase 3
National Institute on Aging (NIA)Phase 3
Lotus Clinical Research, LLCPhase 2

See all OFIRMEV clinical trials

Paragraph IV (Patent) Challenges for OFIRMEV
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MODIFIED DOSING REGIMEN FOR THE REDUCTION OF FEVER

Reduced dose intravenous acetaminophen
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MILD TO MODERATE PAIN

Reduced dose intravenous acetaminophen
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Reduced dose intravenous acetaminophen
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Reduced dose intravenous acetaminophen
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 See Plans and Pricing See Plans and Pricing
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 See Plans and Pricing See Plans and Pricing
>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.

Country Patent Number Title Estimated Expiration
African Intellectual Property Organization (OAPI) 10678 Nouvelles formulations liquides stables à base de paracétamol et leur mode de préparation See Plans and Pricing
Spain 2201316 See Plans and Pricing
Russian Federation 2192249 PARACETAMOL-BASE LIQUID STABLE COMPOSITION AND METHOD OF ITS PREPARING See Plans and Pricing
Austria 241972 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
AstraZeneca
Mallinckrodt
Medtronic
Harvard Business School

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