CLINICAL TRIALS PROFILE FOR OFIRMEV

505(b)(2) Clinical Trials for OFIRMEV

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT02994940 ↗	Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen	Completed	University of California, Davis	Phase 4	2017-08-28	Acetaminophen is frequently used as an adjunct for pain management in pediatric surgical patients. The drug is available in an over the counter, inexpensive oral form as well as a considerably more expensive intravenous form. This study will compare opioid requirements and acetaminophen plasma levels post operatively for two dosing regimens to compare oral versus intravenous routes given pre operatively.

All Clinical Trials for OFIRMEV

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01500109 ↗	Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair	Completed	Loma Linda University	N/A	2011-11-01	The purpose of this investigator-initiated study is to determine whether acetaminophen is an effective pain reliever for primary cleft palate repair in children and possesses opioid sparing effects. Additionally, the investigators will determine if patients who receive acetaminophen have less opioid related side-effects. The study will have three study groups based on whether the patient receives Ofirmev® and opioids (Fentanyl and Morphine), oral acetaminophen elixir and opioids (Fentanyl and Morphine), or opioids (Fentanyl and Morphine) alone. Total opioid (Fentanyl and Morphine) consumption will be tracked for the intraoperative period and 24 hours after surgery for all patients within the study and converted to morphine equivalents.
NCT01520298 ↗	Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients	Withdrawn	Lancaster General Hospital	Phase 3	2011-12-01	This research study is a prospective, randomized, blinded, placebo controlled trial evaluating the benefit of IV acetaminophen (Ofirmev™) as adjuvant analgesia in geriatric hip fracture patients. IV acetaminophen has received FDA approval. IV acetaminophen does not have the liver toxicity as oral acetaminophen. No oral acetaminophen will be administered. All patients diagnosed with a hip fracture aged at least 65 years and expected to undergo surgical intervention are eligible to participate. Hip fractures affect greater than 300,000 geriatric patients annually, representing the second leading cause of hospitalization for this patient population. Pain control in these patients is often problematic due to co-morbidities and changes in their pharmacokinetic and pharmacodynamic profiles. Subjects may receive the normal DVT prophylactic treatments post-op.
NCT01527942 ↗	Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients	Terminated	Saint Francis Care	N/A	2012-03-01	Bariatric patients usually require the use of either intravenous or oral opioid medications. The use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to determine if this will decrease the use of opioids post-operatively for pain management in morbidly obese patients undergoing laparoscopic bariatric surgery.
NCT01544062 ↗	IV Acetaminophen as an Adjunct Analgesic in Cardiac Surgery	Completed	Mallinckrodt	Phase 4	2012-07-01	Patients undergoing cardiac surgery experience significant postoperative pain, which may impact postoperative outcomes. The aim of this single center, double-blind, randomized, placebo controlled trial is to determine if intravenous (IV) acetaminophen will significantly decrease 24 hour postoperative opioid consumption.
NCT01544062 ↗	IV Acetaminophen as an Adjunct Analgesic in Cardiac Surgery	Completed	University of Washington	Phase 4	2012-07-01	Patients undergoing cardiac surgery experience significant postoperative pain, which may impact postoperative outcomes. The aim of this single center, double-blind, randomized, placebo controlled trial is to determine if intravenous (IV) acetaminophen will significantly decrease 24 hour postoperative opioid consumption.
NCT01598701 ↗	Intravenous Acetaminophen in Craniotomy	Completed	Mallinckrodt	Phase 4	2012-05-02	The purpose of this study is to assess the use of intravenous Acetaminophen (OFIRMEV) as an effective adjunct therapeutic agent in patients undergoing craniotomy.
NCT01598701 ↗	Intravenous Acetaminophen in Craniotomy	Completed	The University of Texas Health Science Center, Houston	Phase 4	2012-05-02	The purpose of this study is to assess the use of intravenous Acetaminophen (OFIRMEV) as an effective adjunct therapeutic agent in patients undergoing craniotomy.

Clinical Trial Conditions for OFIRMEV

Condition Name

Condition Name for OFIRMEV
Intervention	Trials
Pain	9
Postoperative Pain	7
Pain, Postoperative	6
Acute Pain	4

Condition MeSH

Condition MeSH for OFIRMEV
Intervention	Trials
Pain, Postoperative	23
Acute Pain	5
Gastric Outlet Obstruction	2
Emergencies	2

Clinical Trial Locations for OFIRMEV

Trials by Country

Trials by Country for OFIRMEV
Location	Trials
United States	80

Trials by US State

Trials by US State for OFIRMEV
Location	Trials
New York	12
Pennsylvania	9
Ohio	8
California	8
Texas	7

Clinical Trial Progress for OFIRMEV

Clinical Trial Phase

Clinical Trial Phase for OFIRMEV
Clinical Trial Phase	Trials
Phase 4	40
Phase 3	6
Phase 2	4

Clinical Trial Status

Clinical Trial Status for OFIRMEV
Clinical Trial Phase	Trials
Completed	36
Terminated	10
Unknown status	7

Clinical Trial Sponsors for OFIRMEV

Sponsor Name

Sponsor Name for OFIRMEV
Sponsor	Trials
Mallinckrodt	13
University of Central Florida	2
University of Pittsburgh	2

Sponsor Type

Sponsor Type for OFIRMEV
Sponsor	Trials
Other	70
Industry	18
NIH	2

Last updated: July 27, 2026

OFIRMEV (IV acetaminophen) clinical trials update, market analysis, and revenue projection

OFIRMEV (IV acetaminophen; active ingredient acetaminophen/paracetamol) has an established clinical position for short-term reduction of fever and postoperative pain in settings where oral dosing is not feasible. The product’s near-term commercial outlook is driven by: (1) U.S. hospital procurement cycles and formulary access, (2) conversion from oral/rectal acetaminophen to IV pathways for opioid-sparing perioperative care, and (3) competitive pressure from alternative IV analgesic and antipyretic options rather than from an immediate “clean-sheet” IV acetaminophen entrant.

No complete, drug-specific clinical-trials dataset (NCT numbers, sponsor arms, phase status, readouts) was provided for this request, so a precise “clinical trials update” limited to OFIRMEV trials cannot be generated from the information available in the prompt.

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What clinical trials involve OFIRMEV (IV acetaminophen) and what is the current phase status?

Which trial types map to OFIRMEV’s label use

For IV acetaminophen, the highest-yield trial categories typically include:

• Postoperative pain trials comparing IV acetaminophen as part of multimodal analgesia vs control arms (placebo or standard care), with endpoints such as:
  • time to meaningful pain reduction
  • total opioid consumption
  • patient-reported pain scores over defined intervals
• Fever/antipyretic trials in inpatient settings where oral intake is limited.

What to look for in “latest updates”

A clinically actionable update for OFIRMEV should include:

• Trial registry entries (NCT) with sponsor, phase, dosing schedule, comparators, and primary endpoint.
• Readout dates and whether the study reached statistical endpoints.
• Safety signals (hepatotoxicity risk management, infusion reaction rates, total daily dose adherence).

Clinical-trials update limitation

Because the request does not include a list of OFIRMEV-specific trial identifiers or an excerpt of recent registry/news items, this section cannot be populated with an accurate, numbered update (phase-by-phase, date-by-date) for OFIRMEV.

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What is OFIRMEV’s market size and growth drivers in the U.S. hospital segment?

Demand drivers

Key demand drivers for IV acetaminophen in U.S. hospitals include:

• Perioperative opioid-sparing protocols that prefer IV non-opioid analgesics.
• Postoperative fast-track pathways (enhanced recovery after surgery, ERAS), where rapid analgesia and predictable dosing matter.
• Patient populations with swallowing issues or malabsorption where oral acetaminophen is impractical.

Procurement and adoption mechanics

• IV products are adopted through hospital pharmacy and therapeutics committee decisions, often tied to formulary tiering and bundled pathway protocols.
• Conversion tends to be incremental: hospitals expand IV acetaminophen use after demonstrating acceptable safety and reduced opioid metrics in internal audits.

Competitive intensity

Competition is usually measured against:

• Alternative IV analgesics (opioid formulations, NSAID-based strategies)
• Non-oral acetaminophen alternatives where available
• Standard-of-care shifts toward multimodal protocols using other agents

Without current sales data, shipment data, or competitor pricing/contracting details in the prompt, market sizing and year-by-year growth rates cannot be stated precisely.

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How does OFIRMEV compare with oral and rectal acetaminophen and other IV analgesics?

Oral vs IV

• Oral acetaminophen offers lower acquisition cost and is used when patients can take oral meds.
• IV acetaminophen offers reliable administration in patients who cannot tolerate oral dosing and supports more consistent perioperative analgesia in early post-op hours.

IV vs opioid-sparing strategies

In ERAS-style pathways, IV acetaminophen functions as a baseline analgesic component intended to:

• reduce opioid requirement
• stabilize pain control during early recovery
• improve discharge readiness metrics tied to opioid minimization

Commercial implication

Where hospitals have strong opioid-sparing protocols, IV acetaminophen penetration tends to be higher.

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When does OFIRMEV face exclusivity and patent expiration pressure?

What determines risk

For OFIRMEV, exclusivity and patent pressure in the U.S. would generally come from:

• Compound or composition-of-matter patents covering acetaminophen IV forms
• Formulation and method-of-use patents tied to dosing regimens and clinical endpoints
• Additional regulatory exclusivities (if any) that delay generic approval or narrow substitution pathways

Limitation

The prompt provides no OFIRMEV patent estate details, Orange Book listings, or filing/expiration dates. A correct, litigation-ready exclusivity timeline cannot be produced.

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What is the Orange Book status of OFIRMEV and what generics are at risk?

What a complete Orange Book review would list

An Orange Book status summary normally includes:

• Listed patents for drug substance and drug product
• Expiration dates
• Orange Book submission types and listing status

Limitation

No Orange Book extract or patent listing data is included in the prompt, so a precise Orange Book table and generic entry risk assessment would be inaccurate if fabricated.

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What generic entry risks exist for OFIRMEV under Paragraph IV?

Paragraph IV mechanics relevant to OFIRMEV

Paragraph IV challenges typically target:

• listed patents associated with the drug product, formulation, or method-of-use claims
• circumstances where a generic can carve around or invalidate specific patents

Limitation

No Paragraph IV case records, ANDA numbers, court filings, or settlement dates are provided in the prompt. A correct risk scenario cannot be produced without that case data.

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How many patents cover OFIRMEV and how strong is the patent estate?

What “strength” analysis requires

A strength assessment usually aggregates:

• independent claim sets (composition, formulation, method-of-use)
• remaining term by jurisdiction
• infringement plausibility for generic ANDA labels
• known litigation outcomes or adverse claim constructions

Limitation

The prompt includes no OFIRMEV patent numbers, assignees, claim summaries, or remaining-life data.

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What patent litigation affects OFIRMEV and what settlement terms are relevant?

What to capture in litigation updates

A litigation update should include:

• brand vs generic defendants
• district courts, filing and dismissal dates
• claim categories asserted
• settlement triggers (launch date carve-outs, payment terms, stipulations)

Limitation

No OFIRMEV litigation docket or settlement references are provided in the prompt.

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What manufacturing and IP barriers affect generic or biosimilar-style substitution for OFIRMEV?

IV acetaminophen is a small-molecule. The practical substitution barriers usually concern:

• formulation and stability requirements for IV infusion quality
• process controls tied to impurity profiles and shelf-life
• clinical or labeling constraints that may reduce “therapeutic equivalence” substitution in practice

Limitation

Without OFIRMEV-specific formulation/process patent data and regulatory assessment information, this cannot be made specific.

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OFIRMEV revenue projection: what is the forecast model and drivers?

Projection structure used for hospital-infusion brands

A defensible revenue projection for an established hospital infusion product generally uses:

1. unit demand (doses or vials) driven by inpatient procedure volume and prescribing protocol penetration
2. net price and rebate/contract effects
3. share shift vs competing IV analgesics
4. substitution risk from generics if/when competitive entry occurs

Limitation

The prompt provides no baseline revenues, dosage unit volumes, net price history, or competitor share. A numerical forecast would be non-auditable if created without the underlying dataset.

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Key Takeaways

• OFIRMEV is positioned for inpatient postoperative pain and fever management when oral therapy is not appropriate.
• Commercial performance is most sensitive to hospital formulary access and opioid-sparing/perioperative pathways rather than to ongoing novelty-driven clinical trial dynamics.
• A fully sourced clinical trials update and a patent/Orange Book exclusivity and Paragraph IV risk assessment cannot be completed from the information in the prompt without introducing inaccuracies.
• A quantitative market size and revenue projection cannot be produced without baseline unit volume, net price, and regulatory/patent timeline inputs.

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FAQs

1. How is OFIRMEV typically used in ERAS postoperative pain protocols in U.S. hospitals?
2. What safety considerations limit IV acetaminophen dosing in inpatient populations?
3. How does hospital formulary placement impact OFIRMEV demand and contracting?
4. What endpoints matter most in postoperative pain trials for IV acetaminophen?
5. When do IV acetaminophen formulations face generic substitution under FDA equivalence frameworks?

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. ClinicalTrials.gov. Search results for IV acetaminophen / OFIRMEV (acetaminophen injection). U.S. National Library of Medicine.
3. FDA. Drug Trials Snapshots and related review materials for acetaminophen injection products. U.S. Food and Drug Administration.