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. Ninety-five 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
Patent Applications:	3,127
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
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010		DISCN	Yes	No	9,399,012*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
Canada	2415403	PROCEDE D'OBTENTION DE FORMULATIONS AQUEUSES DE PRINCIPES ACTIFS SENSIBLES A L'OXYDATION (METHOD FOR OBTAINING AQUEOUS FORMULATIONS OF OXIDATION-SENSITIVE ACTIVE PRINCIPLES)
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.)
Morocco	26926
Peru	20030508	UN PROCESO NUEVO PARA OBTENER FORMULACIONES ACUOSAS DE PRINCIPIOS ACTIVOS SENSIBLES A LA OXIDACION Y LAS SOLUCIONES ASI OBTENIDAS
Poland	326069
World Intellectual Property Organization (WIPO)	0193830
Yugoslavia	103

Market Dynamics and Financial Trajectory for OFIRMEV

Introduction

OFIRMEV, an intravenous (IV) formulation of acetaminophen, was approved by the U.S. Food and Drug Administration in November 2010. Developed and marketed by Mallinckrodt plc, this drug has been a significant player in the pain management and fever relief market. Here, we delve into the market dynamics and financial trajectory of OFIRMEV.

Market Approval and Initial Success

Formulary Approvals

The initial success of OFIRMEV was heavily dependent on securing formulary approvals at major hospitals across the U.S. By the end of 2011, OFIRMEV had been placed on the formulary lists of more than 1,580 institutions, exceeding the company's goal of 800 to 1,000 hospitals. This achievement was crucial as it represented approximately 80% of the market opportunity for OFIRMEV[1].

Target Market and Customer Base

Primary Target Audience

The primary target audience for OFIRMEV includes anesthesiologists, surgeons, certified registered nurse anesthetists, emergency medicine physicians, intensivists, internists, hospitalists, and obstetricians. This focused approach allowed the company to effectively educate and promote the product to key healthcare professionals[1].

Sales and Marketing Strategies

Sales Force and Educational Efforts

Mallinckrodt established a dedicated sales force of hospital sales specialists supported by an experienced commercial management, marketing, and sales operations team. Field-based medical science liaisons played a critical role in informing and educating hospital-based physicians about the appropriate use of OFIRMEV and multi-modal analgesia approaches. This strategy helped in growing demand through new customers, increased order frequency, and higher average order quantities[1].

Financial Performance

Revenue Growth

In its initial launch year, OFIRMEV generated approximately $11.5 million in total net product revenue from over 2,200 unique accounts. This was a significant milestone, indicating strong market traction. The fact that about 1,600 customers placed multiple orders for OFIRMEV during 2011 further underscored the product's acceptance and utility in clinical settings[1].

Gross Margin and Operational Efficiency

By 2013, the gross margin on sales of OFIRMEV had improved to 65% for the fourth quarter, up from 58% in the same period in 2012. This increase was attributed to lower freight costs and price increases implemented in 2012 and 2013. Operating expenses also decreased, primarily due to reduced impairment charges and losses on asset sales[5].

Health Economic Impact

Studies and Outcomes

Retrospective analyses published in the Journal of Knee Surgery highlighted the health economic benefits of using OFIRMEV in total knee arthroplasty (TKA). These studies showed that IV acetaminophen could reduce length of stay, improve discharge status, and decrease readmissions, thereby offering significant health economic advantages[4].

Market Position and Growth Prospects

Acetaminophen Market Context

The global acetaminophen market, of which OFIRMEV is a part, is projected to grow significantly. With a current valuation of $9.8 billion as of 2022, the market is expected to reach $15.2 billion by 2033, driven by a Compound Annual Growth Rate (CAGR) of 4.2%. This growth is fueled by rising healthcare spending and the increasing demand for long-term pain management solutions[3].

Competitive Advantage

OFIRMEV's success can be attributed to its unique position as an IV formulation of acetaminophen, which offers a convenient and effective option for pain and fever management in hospital settings. The oral route of administration, which dominates the acetaminophen market, underscores the preference for easy and effective pain relief methods, further solidifying OFIRMEV's niche in the market[3].

Challenges and Future Outlook

Regulatory and Market Challenges

Despite its successes, OFIRMEV and its parent company, Mallinckrodt, have faced various challenges, including opioid-related litigation and significant restructuring charges. These factors have impacted the company's financial performance, as seen in the substantial operating losses reported in recent years[2].

Strategic Partnerships and Expansion

To navigate these challenges, Mallinckrodt has focused on establishing strategic partnerships for the commercialization of its products outside the U.S. and leveraging its sales force across multiple therapeutic categories in the hospital market. This approach aims to maximize revenue and value from OFIRMEV and other products in the company's portfolio[1].

Key Takeaways

• Formulary Approvals: Securing formulary approvals at major hospitals was crucial for OFIRMEV's initial success.
• Targeted Sales and Marketing: Focused efforts on educating healthcare professionals and promoting the product to key audiences drove demand.
• Financial Performance: OFIRMEV generated significant revenue in its launch year and maintained a strong gross margin.
• Health Economic Impact: Studies highlighted the health economic benefits of using OFIRMEV in surgical settings.
• Market Growth: The global acetaminophen market is projected to grow significantly, with OFIRMEV positioned to benefit from this trend.

FAQs

What is OFIRMEV and when was it approved?

OFIRMEV is an intravenous (IV) formulation of acetaminophen approved by the U.S. Food and Drug Administration in November 2010.

Who is the primary target audience for OFIRMEV?

The primary target audience includes anesthesiologists, surgeons, certified registered nurse anesthetists, and other hospital-based physicians.

How did Mallinckrodt achieve initial success with OFIRMEV?

Mallinckrodt achieved initial success by securing formulary approvals at over 1,580 hospitals and educating healthcare professionals about the product's use.

What are the projected growth prospects for the acetaminophen market?

The global acetaminophen market is expected to grow to $15.2 billion by 2033, driven by a CAGR of 4.2%.

What health economic benefits has OFIRMEV shown in clinical studies?

Studies have shown that OFIRMEV can reduce length of stay, improve discharge status, and decrease readmissions in surgical settings.

What challenges has Mallinckrodt faced in relation to OFIRMEV and its financial performance?

Mallinckrodt has faced challenges including opioid-related litigation and significant restructuring charges, impacting its financial performance.

Sources

1. Mallinckrodt 2011 Annual Report - Investor Relations
2. Mallinckrodt plc Reports Strong Fourth Quarter and 2019 Results - Mallinckrodt News Release
3. Acetaminophen Market Skyrockets to a Whopping US$ 15.2 Billion Valuation by 2033 - PharmiWeb
4. New Health Economic Data on Mallinckrodt's OFIRMEV - PR Newswire
5. Cadence Pharmaceuticals Reports Fourth Quarter and Full Year 2013 Results - Mallinckrodt News Detail