ULTRAM ER Drug Patent Profile

Which patents cover Ultram Er, and when can generic versions of Ultram Er launch?

Ultram Er is a drug marketed by Valeant Pharms and is included in one NDA.

The generic ingredient in ULTRAM ER is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ultram Er

A generic version of ULTRAM ER was approved as tramadol hydrochloride by SUN PHARM INDS INC on June 19^th, 2002.

Summary for ULTRAM ER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	21
Patent Applications:	2,442
What excipients (inactive ingredients) are in ULTRAM ER?	ULTRAM ER excipients list
DailyMed Link:	ULTRAM ER at DailyMed

Recent Clinical Trials for ULTRAM ER

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

Sponsor	Phase
Henry Ford Health System	Phase 4
Medical College of Wisconsin	Phase 2
University of Pennsylvania	Phase 4

See all ULTRAM ER clinical trials

Paragraph IV (Patent) Challenges for ULTRAM ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ULTRAM ER	Extended-release Tablets	tramadol hydrochloride	300 mg	021692	1	2007-09-25
ULTRAM ER	Extended-release Tablets	tramadol hydrochloride	200 mg	021692	1	2007-03-28
ULTRAM ER	Extended-release Tablets	tramadol hydrochloride	100 mg	021692	1	2007-01-08

US Patents and Regulatory Information for ULTRAM ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-001	Sep 8, 2005		DISCN	Yes	No
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-002	Sep 8, 2005		DISCN	Yes	No
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-003	Sep 8, 2005		DISCN	Yes	No

Expired US Patents for ULTRAM ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-002	Sep 8, 2005	6,254,887
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-001	Sep 8, 2005	6,254,887
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-003	Sep 8, 2005	7,074,430
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-003	Sep 8, 2005	6,254,887
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-001	Sep 8, 2005	7,074,430
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-002	Sep 8, 2005	7,074,430

International Patents for ULTRAM ER

See the table below for patents covering ULTRAM ER around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2005203460
Czech Republic	289650	Způsob výroby léčiva, uvolňujícího kontrolovatelně jeho účinnou látku (Process for preparing a medicament controllably releasing active substance thereof)
Czech Republic	9402866
European Patent Office	1504758
Finland	122717
Poland	304062
South Africa	9407742

Supplementary Protection Certificates for ULTRAM ER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2488169	C202330042	Spain		PRODUCT NAME: COCRISTAL DE TRAMADOL, OPCIONALMENTE EN FORMA DE UNA SAL FISIOLOGICAMENTE ACEPTABLE, Y CELECOXIB; NATIONAL AUTHORISATION NUMBER: 89051; DATE OF AUTHORISATION: 20230925; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 89051; DATE OF FIRST AUTHORISATION IN EEA: 20230925
0566709	C300152	Netherlands		PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
0566709	SPC/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925

Market Dynamics and Financial Trajectory of Tramadol (ULTRAM ER)

Market Size and Forecast

The global tramadol market, which includes ULTRAM ER, is experiencing significant growth. As of 2022, the market was valued at approximately USD 4.5 billion to USD 5.26 billion, depending on the source[1][3].

• By 2032, the market is projected to reach USD 8.6 billion to USD 7.29 billion, with a Compound Annual Growth Rate (CAGR) ranging from 4.41% to 6.87% during the forecast period[1][3][4].

Driving Factors

Several key factors are driving the growth of the tramadol market:

Rising Prevalence of Pain Disorders

• Chronic pain conditions such as arthritis, neuropathy, and fibromyalgia are increasingly prevalent. It is estimated that at least 10% of the world’s population is affected by chronic pain, with 1 in every 5 adults suffering from pain, some of which remains undiagnosed until it becomes chronic[1].

Aging Population

• The increase in the geriatric population, which often requires pain management for conditions like lower back pain, is a significant driver. This demographic shift necessitates more surgeries, therapies, and pain management drugs[1].

Healthcare Infrastructure and Awareness

• Growing healthcare infrastructure in emerging markets and rising awareness about pain management are also boosting the market. Increased R&D activities and the launch of new formulations further contribute to this growth[1][4].

Regulatory Environment

The regulatory landscape plays a crucial role in the market dynamics of tramadol:

FDA Approval and Global Regulations

• The IV formulation of tramadol hydrochloride has faced regulatory hurdles in the U.S., despite its efficacy in clinical trials. However, in some countries outside the U.S., tramadol IV is already in use, highlighting the need for consistent global regulatory standards[3].

Financial Projections

The financial trajectory of the tramadol market is promising:

Market Growth

• The market is expected to grow significantly, with projections indicating a rise from the current valuation to USD 7.29 billion by 2030 or USD 8.6 billion by 2032[1][3].

CAGR

• The CAGR for the market is estimated to be around 4.41% to 6.87% over the forecast periods, indicating steady and robust growth[1][3].

Investment and Innovation

Major pharmaceutical companies are investing heavily in the development and marketing of tramadol:

Research and Development

• Continuous innovation in drug delivery systems and formulations is driving market growth. The development of IV formulations and other delivery methods is expected to stimulate further investment[3][4].

Market Expansion

• Companies are expanding their product lines and entering new markets, particularly in developing countries where there is a growing demand for pain management drugs[1][4].

Public Health Impact

The approval and use of tramadol have significant public health implications:

Pain Relief

• Tramadol is a preferred choice for practitioners in pain relief, addressing unmet medical needs and diversifying the utility of the drug. This has led to an increase in regulatory approvals for new indications, further driving market growth[4].

Adverse Events

• Despite its benefits, tramadol is associated with adverse events, which can restrict market growth. However, ongoing research and development aim to address these limitations and enhance the drug's safety profile[4].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the tramadol market:

Initial Decline

• The pandemic led to a decrease in patient visits for neuropathic pain, dental pain, and osteoarthritis, as well as a reduction in elective and non-elective surgeries. This resulted in a temporary decline in tramadol prescriptions[4].

Post-Pandemic Rebound

• However, in 2022, the market rebounded to pre-pandemic levels. The easing of pandemic restrictions led to an increase in surgeries, which in turn increased the prescriptions of pain management drugs like tramadol[4].

Key Players and Market Segments

The tramadol market is dominated by several key players:

Top Players

• Companies such as Grünenthal, Zydus Group, and GSK plc are major players in the market. These companies are driving innovation and expansion in the tramadol market[4].

Market Segments

• The market is segmented by dosage form, route of administration, distribution channel, and region. Tablets under the dosage form segment have been leading the market, with North America being a dominant region[4].

Examples and Statistics

• Revenue Growth: Par Pharmaceutical, Inc. reported significant revenue growth in 2009, partly due to the launch of tramadol ER in the fourth quarter. Total net revenues for the fourth quarter of 2009 were $290.3 million, up nearly 80% from the year-ago period[2].

• Market Size: The global tramadol market stood at USD 2.11 billion in 2023 and is projected to reach USD 3.50 billion by 2032, with a CAGR of 5.8% during the forecast period[4].

Quotes from Industry Experts

While specific quotes from industry experts on tramadol are not available in the provided sources, the emphasis on innovation and regulatory approvals is a common theme:

"The rise in the number of regulatory approvals for new indications of drugs signifies a strategic expansion, tapping into unmet medical needs and diversifying the utility of the drug."[4]

Illustrative Statistics

• Chronic Pain Prevalence: At least 10% of the world’s population is affected by chronic pain, with 1 in every 5 adults suffering from pain[1].
• Market Growth: The tramadol market is expected to grow from USD 4.5 billion in 2022 to USD 8.6 billion by 2032, at a CAGR of 6.8%[1].
• Regional Dominance: North America dominated the market in 2023, with a valuation of USD 1.05 billion[4].

Key Takeaways

• The tramadol market is driven by the rising prevalence of pain disorders, an aging population, and growing healthcare infrastructure.
• Regulatory approvals and innovations in drug delivery systems are key factors in market growth.
• The COVID-19 pandemic had a temporary negative impact, but the market has rebounded.
• Major pharmaceutical companies are investing heavily in R&D and market expansion.
• The market is expected to grow significantly, with a CAGR of 4.41% to 6.87% over the forecast period.

FAQs

1. What is the current market size of the tramadol drug market? The current market size of the tramadol drug market was valued at approximately USD 4.5 billion to USD 5.26 billion in 2022[1][3].

2. What is the projected growth rate of the tramadol market? The tramadol market is expected to grow at a CAGR of 4.41% to 6.87% from 2023 to 2032[1][3][4].

3. What are the main drivers of the tramadol market growth? The main drivers include the rising prevalence of pain disorders, an increase in the geriatric population, growing healthcare infrastructure, and increasing R&D activities[1][4].

4. How did the COVID-19 pandemic impact the tramadol market? The pandemic led to a temporary decline in tramadol prescriptions due to reduced patient visits and surgeries, but the market rebounded to pre-pandemic levels in 2022[4].

5. Who are the top players in the tramadol market? The top players include Grünenthal, Zydus Group, and GSK plc[4].

Cited Sources

1. Global Market Insights: Tramadol Drug Market Size & Trends Analysis Report, 2032[1].
2. Biospace: Par Pharmaceutical, Inc. Reports Adjusted EPS of $0.65 for Fourth Quarter 2009[2].
3. Drug Patent Watch: TRAMADOL HYDROCHLORIDE - Generic Drug Details[3].
4. Fortune Business Insights: Tramadol Market Size, Share, Forecast | Growth Report [2032][4].