OFIRMEV Drug Patent Profile

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. One hundred 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.

Summary for OFIRMEV

International Patents:	4
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	179
Clinical Trials:	60
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

See drug prices for OFIRMEV

Recent Clinical Trials for OFIRMEV

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

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

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	10,383,834
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010		DISCN	Yes	No	9,987,238*PED				Y
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010		DISCN	Yes	No	9,610,265*PED				Y

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	6,028,222*PED
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010	6,992,218*PED

International Patents for OFIRMEV

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

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.)
African Regional IP Organization (ARIPO)	957	Novel stable liquid paracetamol compositions, and method for preparing same.
Spain	2201316

Market Dynamics and Financial Trajectory for OFIRMEV (IV Acetaminophen)

Last updated: July 27, 2025

Introduction

OFIRMEV, an intravenous formulation of acetaminophen (paracetamol), has established itself as a significant analgesic and antipyretic option within the hospital setting. Launched in 2010 by Mallinckrodt Pharmaceuticals, OFIRMEV addresses the need for non-opioid pain management, especially amidst the opioid crisis and the growing demand for opioid-sparing approaches. Its unique pharmacokinetic profile, ease of administration, and established safety profile contribute to its expanding usage. This report examines the core market dynamics influencing OFIRMEV’s positioning, alongside its financial trajectory amidst evolving healthcare trends.

Market Overview and Key Drivers

Growing Demand for Non-Opioid Analgesics

The opioid epidemic has significantly reshaped pain management paradigms globally. Regulatory agencies and healthcare providers seek alternatives to opioids due to their high addiction potential and adverse side effects. OFIRMEV, marketed as an opioid-sparing agent, has experienced increased adoption in acute care settings, including surgical, trauma, and obstetric procedures. The CDC’s guidelines emphasize multimodal and non-opioid strategies, fueling demand for IV acetaminophen [1].

Clinical Efficacy and Safety Profile

OFIRMEV’s efficacy in reducing postoperative pain and fever, coupled with a favorable safety profile, bolsters its clinical preference. Unlike NSAIDs, OFIRMEV does not carry significant bleeding risks or renal toxicity, widening its applicability, especially among patients contraindicated for NSAIDs. Its rapid onset and predictable absorption make it suitable for acute care protocols.

Market Penetration and Institutional Adoption

Hospital formulary inclusion and clinical guidelines directly impact OFIRMEV’s sales. Institutional preferences shift based on evidence-based medicine, formulary negotiations, and reimbursement landscapes. Its competition primarily comprises traditional analgesics and emerging non-opioid alternatives such as ketamine infusions and NSAIDs.

Competitive Landscape and Challenges

Competition from Generic and Alternative Formulations

As patent protections expired, generic IV acetaminophen formulations entered the market, exerting downward pressure on prices. Although branded OFIRMEV maintains a premium positioning with established clinical familiarity, price competition limits overall revenue potential.

Reimbursement and Pricing Pressures

Reimbursement policies, especially in fragmented healthcare markets, influence utilization. Insurance companies and health systems gravitate toward cost-effective options, driven by bundled payments and value-based care models. While OFIRMEV’s clinical advantages justify higher reimbursement in some contexts, cost considerations constrain its broader adoption.

Regulatory and Safety Concerns

Though generally safe, overdose risks and the rare occurrence of hepatotoxicity necessitate ongoing monitoring. Regulatory agencies periodically reassess risk-benefit profiles, influencing prescribing behaviors. Post-market safety data collection and label updates may affect future utilization.

Financial Performance and Trajectory

Revenue Trends and Market Share

Since its launch, OFIRMEV sustained strong initial growth driven by hospital adoption and clinical endorsements. However, over recent years, revenue growth has plateaued, reflecting market saturation and increased competition from generics. In 2022, Mallinckrodt reported that OFIRMEV’s net sales faced pressure from reimbursement shifts and market consolidation [2].

Impact of Patent Expiry and Generic Competition

The expiration of key patents around 2018 facilitated broader availability of generic IV acetaminophen, reducing pricing power for the branded product. This shift has shifted revenue streams downward, though clinic familiarity and clinical preferences sustain a baseline demand.

Future Revenue Drivers

Emerging opportunities include expansion into outpatient and ambulatory infusion settings, particularly with the growing emphasis on perioperative pain management outside traditional hospital settings. Additionally, strategic marketing emphasizing safety and opioid-sparing benefits could rejuvenate growth in select markets.

Market Expansion in Emerging Economies

Emerging markets, with rising healthcare infrastructure investments, present untapped opportunities. However, price sensitivity and regulatory hurdles pose significant challenges. Tailored pricing strategies and partnerships with local distributors will influence OFIRMEV’s penetration potential.

Innovation and Pipeline Opportunities

While currently focused on IV formulations, research into oral and depot formulations may diversify offerings. Furthermore, adjunctive uses, such as in the management of chemotherapy-induced neuropathy, represent niche growth avenues.

Strategic Outlook and Trends

Emphasis on Value-Based Healthcare

In markets emphasizing outcomes, OFIRMEV’s role as part of multimodal analgesia reflects its value proposition. Demonstrating cost savings through reduced opioid-related adverse events and length of stay can bolster its appeal.

Integration with Enhanced Recovery After Surgery (ERAS)

ERAS protocols prioritize early mobilization and reduced opioid use. OFIRMEV’s integration into these pathways supports sustained demand, especially as hospitals seek accreditation and improved patient outcomes.

Regulatory Developments and Safety Monitoring

Stringent post-market surveillance may alter prescribing guidelines. Staying aligned with regulatory expectations enhances market stability.

Key Challenges and Opportunities

Challenges	Opportunities
Price competition from generics	Differentiation through clinical evidence and safety profile
Reimbursement pressures	Integration into value-based care models
Market saturation in developed regions	Expansion into outpatient and emerging markets
Safety concerns and regulatory scrutiny	Leveraging safety data for clinician confidence

Conclusion

The financial trajectory of OFIRMEV reflects its critical role in modern pain management, tempered by market saturation, generic competition, and reimbursement dynamics. While current growth may stabilize, strategic focus on outpatient markets, value-based partnerships, and emerging indications can sustain its long-term profitability. To maximize potential, stakeholders must navigate competitive pressures and leverage clinical advantages, emphasizing the drug’s role in opioid-sparing, safe analgesia.

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Key Takeaways

• Growing Preference for Non-Opioid Analgesics: Regulatory and clinical trends favor OFIRMEV as part of multimodal pain management, supporting sustained demand.

• Market Competition and Patent Expiry: Generic competition has curtailed premium pricing, necessitating differentiation through clinical value propositions.

• Reimbursement and Healthcare Policy: Cost pressures require strategic positioning within value-based care models to preserve profitability.

• Expansion Opportunities: Outpatient infusion settings and emerging markets present growth avenues, contingent upon tailored strategies.

• Regulatory Vigilance: Ongoing safety monitoring and guideline updates remain critical to maintaining clinical trust and market relevance.

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FAQs

1. How has the patent expiration affected OFIRMEV’s market share?
Patent expiration led to the entrance of generic IV acetaminophen options, exerting pricing pressures and reducing overall revenue for the branded product. Despite this, brand recognition and clinical familiarity sustain baseline demand.

2. What role does OFIRMEV play in opioid-sparing pain management?
OFIRMEV provides effective analgesia with minimal respiratory depression and addiction potential, fitting into multimodal strategies that reduce reliance on opioids, especially postoperatively.

3. Are there emerging markets for OFIRMEV?
Yes, particularly in developing regions investing in healthcare infrastructure. Market entry requires considerations of pricing, regulatory approval, and distribution partnerships.

4. How does reimbursement influence OFIRMEV’s sales?
Reimbursement policies directly impact hospital formulary decisions. Favorable reimbursement supports adoption, whereas cost constraints may limit use in certain settings.

5. What strategic measures can enhance OFIRMEV’s market position?
Focusing on outpatient applications, demonstrating cost-effectiveness in reducing complications, compliance with regulatory standards, and marketing its safety and opioid-sparing benefits are key strategies.

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References

[1] Centers for Disease Control and Prevention (CDC). "What Can Be Done to Address the Opioid Overdose Epidemic?" 2021.
[2] Mallinckrodt Pharmaceuticals. "Annual Financial Reports," 2022.