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. Seventeen 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:	26
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
Pfizer	Phase 4
Gia Dinh People Hospital	N/A
The Catholic University of Korea	N/A

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
European Patent Office	0566709	COMPOSITION CONTENANT UN COMPOSE DE LA FAMILLE DU TRAMADOL ET DE L'ACETAMINOPHENE, ET SON UTILISATION (COMPOSITION COMPRISING A TRAMADOL COMPOUND AND ACETAMINOPHEN, AND ITS USE)
Canada	2095523	COMPOSITION COMPRENANT DU TRAMADOL ET DE L'ACETAMINOPHENE ETSON UTILISATION (COMPOSITION COMPRISING A TRAMADOL MATERIAL AND ACETAMINOPHENAND ITS USE)
Hungary	9301313
Denmark	0566709
Luxembourg	91079
Taiwan	242562

Supplementary Protection Certificates for ULTRACET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0566709	91079	Luxembourg		91079, EXPIRES: 20170903
0566709	300152	Netherlands		300152, 20120903, EXPIRES: 20170404
0566709	SPC/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925

ULTRACET Market Analysis and Financial Projection Experimental

Tramadol and Ultracet Market Dynamics and Financial Trajectory

Introduction to Tramadol and Ultracet

Tramadol, a synthetic opioid analgesic, is widely used to manage moderate to moderately severe pain. One of its notable formulations is Ultracet, a combination of tramadol and acetaminophen. Understanding the market dynamics and financial trajectory of tramadol, particularly in its Ultracet formulation, is crucial for stakeholders in the pharmaceutical industry.

Global Tramadol Market Size and Growth

The global tramadol market, which includes Ultracet, has been experiencing significant growth. As of 2023, the market size was valued at approximately $2.11 billion and is projected to grow to $3.50 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 5.8% during the forecast period[1].

Regional Market Dominance

North America dominates the tramadol market, holding a market share of 49.76% in 2023. This dominance is attributed to the high prevalence of chronic pain conditions, advanced healthcare infrastructure, and strong regulatory frameworks[1].

Key Drivers of Market Growth

Increasing Prevalence of Pain-Related Diseases

The rise in chronic diseases such as osteoarthritis, cancer, and neuropathic pain significantly increases the demand for pain management drugs like tramadol. This trend is expected to continue, driving market growth[1].

Regulatory Approvals and New Indications

Regulatory approvals for new indications of tramadol are a key driver of market growth. Each new approval expands the drug's utility, tapping into unmet medical needs and diversifying its applications[1].

Surgeries and Hospital Admissions

The increase in the number of surgeries and hospital admissions post-pandemic has led to an uptick in prescriptions for pain management drugs, including tramadol. This trend is anticipated to continue, contributing to market growth[1].

Dosage Forms and Market Segmentation

Dominance of Tablets

The tablets segment, which includes Ultracet, holds the dominant market share due to factors such as ease of manufacturing, convenience of dosing and administration, and cost-effectiveness. Tramadol tablets come in various formulations, including immediate-release, extended-release, and sustained-release, which provide prolonged analgesic effects and reduce the frequency of dosing[1].

Regulatory Aspects and Challenges

Regulatory Frameworks

Tramadol is subject to stringent regulatory frameworks, particularly in the United States, due to its potential for abuse and dependence. Regulatory approvals from agencies like the FDA, WHO, and EMA are crucial for market penetration and growth[4].

Safety Concerns and Side Effects

Factors such as neonatal opioid withdrawal syndrome due to concomitant use in pregnancy and the potential for serious adverse or unacceptable side effects can restrict market growth. These safety concerns necessitate careful monitoring and adherence to regulatory guidelines[1][2].

Financial Performance and Projections

Market Size Projections

The global tramadol market, including Ultracet, is expected to reach $3.50 billion by 2032. Another projection suggests the market could reach nearly $6.75 billion by 2030, growing at a CAGR of 6.86% from 2024 to 2030[1][4].

Revenue and Sales

Companies like Pfizer, Johnson & Johnson, and Teva Pharmaceuticals, which are key players in the tramadol market, leverage their extensive distribution networks and strong R&D capabilities to maintain a competitive edge. These companies contribute significantly to the revenue and sales growth in the market[4].

Competitive Landscape

Key Players

The tramadol market, including Ultracet, is dominated by major pharmaceutical companies such as Pfizer Inc., Johnson & Johnson, Teva Pharmaceuticals, and GSK plc. These companies invest heavily in research and development, ensuring continuous innovation and market dominance[1][4].

Emerging Markets and Growth Opportunities

Asia Pacific Region

The Asia Pacific region, particularly countries like China and India, is witnessing rapid growth in the tramadol market. This growth is driven by improving healthcare infrastructure, rising disposable incomes, and increasing awareness about pain management. These emerging markets offer substantial growth opportunities for tramadol and its formulations like Ultracet[4].

Impact of COVID-19

The COVID-19 pandemic had a negative impact on the tramadol market, primarily due to reduced patient visits for pain-related conditions and a decrease in elective and non-elective surgeries. However, the market rebounded to pre-pandemic levels in 2022 and is projected to experience moderate growth throughout the forecast period[1].

Innovations and Future Trends

Drug Delivery Systems and Digital Health

Innovations in drug delivery systems and the increasing adoption of digital health solutions are shaping the future of the tramadol market. These advancements are expected to enhance patient compliance, improve efficacy, and expand market reach[4].

Key Takeaways

• The global tramadol market, including Ultracet, is projected to grow significantly, driven by increasing chronic pain prevalence, regulatory approvals, and post-pandemic surgical activities.
• North America dominates the market, with tablets being the most preferred dosage form.
• Regulatory frameworks and safety concerns are critical factors influencing market growth.
• Emerging markets in the Asia Pacific region offer substantial growth opportunities.
• Innovations in drug delivery and digital health are expected to shape the market's future trajectory.

FAQs

1. What is the projected market size of the global tramadol market by 2032? The global tramadol market is expected to reach $3.50 billion by 2032, growing at a CAGR of 5.8% from 2024 to 2032[1].

2. Which region dominates the tramadol market? North America dominates the tramadol market, holding a market share of 49.76% in 2023[1].

3. What are the key drivers of the tramadol market growth? Key drivers include the increasing prevalence of pain-related diseases, regulatory approvals for new indications, and the rise in surgeries and hospital admissions post-pandemic[1].

4. What are the challenges facing the tramadol market? Challenges include stringent regulatory frameworks, safety concerns such as neonatal opioid withdrawal syndrome, and potential side effects[1][2].

5. Which companies are the key players in the tramadol market? Key players include Pfizer Inc., Johnson & Johnson, Teva Pharmaceuticals, and GSK plc[1][4].

Sources

1. Fortune Business Insights: Tramadol Market Size, Share, Forecast | Growth Report [2032]
2. Avenue Therapeutics, Inc.: 10-K - 03/18/2024
3. BioSpace: Tramadol Drug Market: Increasing number of surgeries and treatment procedures to drive the market
4. Stellar Market Research: Tramadol Market: Global Industry Analysis and Forecast (2024-2030)