ULTRACET Drug Patent Profile

When do Ultracet patents expire, and what generic alternatives are available?

Ultracet is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in ULTRACET is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

Summary for ULTRACET

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	27
Drug Prices:	Drug price information for ULTRACET
What excipients (inactive ingredients) are in ULTRACET?	ULTRACET excipients list
DailyMed Link:	ULTRACET at DailyMed

See drug prices for ULTRACET

Recent Clinical Trials for ULTRACET

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

Sponsor	Phase
Seoul National University Hospital	NA
Dong-A ST Co., Ltd.	NA
Eulji University Hospital	NA

See all ULTRACET clinical trials

US Patents and Regulatory Information for ULTRACET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	ULTRACET	acetaminophen; tramadol hydrochloride	TABLET;ORAL	021123-001	Aug 15, 2001		DISCN	Yes	No

Expired US Patents for ULTRACET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ULTRACET	acetaminophen; tramadol hydrochloride	TABLET;ORAL	021123-001	Aug 15, 2001
Janssen Pharms	ULTRACET	acetaminophen; tramadol hydrochloride	TABLET;ORAL	021123-001	Aug 15, 2001

International Patents for ULTRACET

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

Country	Patent Number	Title	Estimated Expiration
China	1071571
Japan	3381190
Australia	2579992
Netherlands	300152
Australia	651247
Russian Federation	2121346	COMPOSITION CONTAINING SUBSTANCE TRAMADOL AND ACETAMINOPHEN AND A METHOD OF TREATMENT USING THEREOF
World Intellectual Property Organization (WIPO)	9304675

Supplementary Protection Certificates for ULTRACET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0566709	SPC/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
0566709	300152	Netherlands		300152, 20120903, EXPIRES: 20170404
0566709	91079	Luxembourg		91079, EXPIRES: 20170903
0566709	SPC023/2008	Ireland		SPC023/2008: 20090921, EXPIRES: 20170404
0566709	C300152	Netherlands		PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ULTRACET

Last updated: July 30, 2025

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Introduction

ULTRACET, a combined formulation of tramadol and acetaminophen, epitomizes a pivotal segment within analgesic therapeutics, catering primarily to moderate to severe pain management. As a prescription medication, its market face is shaped by evolving regulatory landscapes, competitive forces, epidemiological trends, and innovation trajectories. This analysis delves into the current market dynamics and financial forecast for ULTRACET, providing vital insights for stakeholders navigating this complex pharmaceutical environment.

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Product Overview and Therapeutic Position

ULTRACET combines tramadol, a synthetic opioid analgesic, with acetaminophen (paracetamol), a non-opioid analgesic and antipyretic. Approved across various jurisdictions, its efficacy in managing pain with a potentially lower opioid dose profile renders it an attractive alternative amidst rising concerns over opioid dependence. Its therapeutic positioning leverages synergistic effects, offering improved pain control while ostensibly reducing side effects and abuse potential compared to standalone opioids.

The formulation is primarily prescribed in outpatient settings for moderate to severe pain post-surgical procedures, in musculoskeletal conditions, and for chronic pain management as part of multimodal analgesia.

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Global Market Dynamics

Regulatory and Legal Environment

The regulatory landscape significantly influences ULTRACET's marketability. Stringent regulations surrounding opioid use, coupled with growing scrutiny on combination analgesics, have led to tighter prescription controls in developed countries. Notably, the opioid epidemic in North America prompted agencies like the Food and Drug Administration (FDA) and Health Canada to impose restrictions, thereby affecting market access and demand.

Conversely, regions with evolving pain management guidelines, such as Asia-Pacific and parts of Europe, show increased acceptance of combination analgesics, presenting growth opportunities. The approval of ULTRACET or similar formulations hinges on jurisdiction-specific regulatory pathways, requiring manufacturers to demonstrate safety, efficacy, and appropriate abuse-deterrent properties.

Epidemiological Trends and Demographic Shifts

Rising prevalence of chronic pain conditions, the aging global population, and increasing surgical interventions drive demand for effective analgesics. According to the Global Burden of Disease Study, musculoskeletal disorders and cancer-related pain are on the rise globally, expanding the target patient base.

Developed economies witness higher per capita analgesic consumption, but emerging markets, characterized by expanding healthcare infrastructures, represent burgeoning demand. The increasing incidence of pain-related disorders among the elderly further accentuates the need for formulations like ULTRACET, which offer effective pain management with manageable safety profiles.

Market Competition

ULTRACET operates within a competitive analgesic landscape that includes both opioid and non-opioid agents. Its primary competitors are standalone non-opioid formulations, other opioid combinations, and newer multimodal pain management drugs.

Notably, the rise of abuse-deterrent formulations (ADFs) and alternative modalities such as nerve blocks, nonsteroidal anti-inflammatory drugs (NSAIDs), and biologics influences prescribing patterns. The entry of generic versions post-patent expiry intensifies price competition, benefitting healthcare systems but exerting pressure on brand revenues.

Health Technology Assessment and Prescribing Trends

Health technology assessments (HTAs) influence reimbursement and formulary decisions. Payers increasingly scrutinize cost-effectiveness, safety, and misuse potential. The inclusion of ULTRACET in formularies depends on demonstrated value propositions, including reduced hospitalization rates for uncontrolled pain and minimized adverse event profiles.

Prescribing trends lean towards multimodal analgesia strategies that reduce opioid reliance—a factor that can both challenge and create opportunities for ULTRACET. Its positioning as part of combination therapy must align with evolving guidelines emphasizing opioid-sparing approaches.

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Financial Trajectory and Market Forecast

Historical Performance

While ULTRACET's specific sales data are proprietary, industry estimates position the global analgesics market valued at approximately US$35 billion in 2022, with opioid analgesics representing a significant share. The segment's growth has been historically driven by increasing pain management needs, though recent years have seen stagnation due to regulatory constraints and societal concerns over opioid misuse.

Forecasting Future Growth

The forecast for ULTRACET hinges on multiple factors:

• Patent and Generic Landscape: Originator formulations typically enjoy initial high margins, but patent expirations catalyze price erosion through generics. ULTRACET's patent life and exclusivity periods, if recent, will shape revenue streams over the coming years.

• Market Penetration: Expansion into emerging markets, where pain management remains underserved, offers growth avenues. Strategic partnerships with local distributors and alignment with local regulatory environments are key.

• Product Innovation: Incorporating abuse-deterrent features and improved formulations can sustain competitive advantage. Enhanced safety profiles appeal to both regulators and prescribers, positioning ULTRACET favorably.

• Pricing Strategies and Reimbursement Policies: Negotiation with payers, inclusion in formularies, and value-based pricing models influence profitability. Stricter reimbursement criteria among payers could limit growth unless supplemented by demonstrable cost savings and clinical benefits.

• Impact of Alternative Therapies: The increasing adoption of non-opioid modalities and non-pharmacologic interventions may temper growth projections for combination opioids, including ULTRACET. Nonetheless, for certain patient subsets, ULTRACET will maintain relevance.

Projected Market Growth

Analysts project the analgesics market to grow at a Compound Annual Growth Rate (CAGR) of 4-6% through 2028, with opioid combination therapies like ULTRACET expected to see nuanced trajectories. Initially, a plateau phase may occur due to regulatory constraints, but targeted expansion into emerging markets and product refinement could stimulate renewed growth, averaging approximately 3-4% CAGR over the next five years.

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Risks and Opportunities

Risks:

• Heightened regulatory scrutiny over opioids increasing barriers to market access.
• Negative perceptions related to opioid misuse impacting prescribing.
• Competition from non-opioid analgesics and innovation in pain management.
• Patent expirations leading to significant erosion in revenue.

Opportunities:

• Expansion into markets with unmet pain management needs.
• Development of abuse-deterrent formulations and safer delivery systems.
• Integration into multimodal pain management regimens.
• Strategic alliances with healthcare providers and payers to demonstrate value.

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Key Takeaways

• ULTRACET remains a relevant analgesic option amid growing pain management needs driven by demographic and epidemiological factors.
• Regulatory environments significantly influence its market access; proactive compliance and innovation are essential.
• Market growth prospects are moderate, contingent upon lifecycle management strategies, including product differentiation and geographic expansion.
• Competitive pressures necessitate investments in safety profiles and cost-effectiveness demonstrations.
• Stakeholders should monitor emerging alternative therapies and evolving prescribing policies to adapt strategies accordingly.

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FAQs

1. What factors are likely to influence ULTRACET’s sales in the next five years?
Regulatory developments, patent status, pricing strategies, market expansion efforts, and competition from non-opioid pain therapies will collectively impact ULTRACET’s sales trajectory.

2. How do regulatory changes impact the prescription pattern of ULTRACET?
Stricter opioid control measures reduce prescribing, especially in regions with high misuse prevalence. Conversely, if ULTRACET incorporates abuse-deterrent features, it may sustain or increase prescriptions.

3. What role does patent expiry play in ULTRACET’s market presence?
Patent expiration allows generics to enter the market, leading to price reductions and potential revenue decline for brand-name formulations, unless differentiation strategies are implemented.

4. Can ULTRACET expand into emerging markets?
Yes, if it aligns with local regulatory requirements and demonstrates value, ULTRACET can penetrate markets with growing healthcare infrastructures and unmet pain management needs.

5. What are the opportunities for innovation in ULTRACET’s formulation?
Developing abuse-deterrent formulations, extended-release versions, and combination therapies with novel agents can enhance safety, efficacy, and market competitiveness.

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References

[1] Global Data, "Analgesics Market Size & Trends," 2022.
[2] FDA, "Opioid Analgesics Regulatory Updates," 2023.
[3] WHO, "Pain Management and Analgesic Use," 2022.
[4] IMS Health, "Pharmaceutical Market Forecasts," 2023.
[5] MarketWatch, "COVID-19 Impact on Pain Management Drugs," 2022.