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-five 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:	67
Clinical Trials:	21
Patent Applications:	2,793
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	021692-001	Sep 8, 2005
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-003	Sep 8, 2005
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-002	Sep 8, 2005
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-001	Sep 8, 2005
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-002	Sep 8, 2005
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-003	Sep 8, 2005

International Patents for ULTRAM ER

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1203581
Norway	944473
Australia	2967992
European Patent Office	1468679	Composition de tramadol à libération contrôlée (Controlled release formulation containing tramadol)
Norway	941719
Hungary	9401858

Supplementary Protection Certificates for ULTRAM ER

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
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

Market Dynamics and Financial Trajectory for Ultram ER

Last updated: July 30, 2025

Introduction

Ultram ER (extended-release tramadol) has established itself as a prominent analgesic within the chronic pain management segment. Its unique pharmacokinetic profile presents both therapeutic benefits and market opportunities, shaped by regulatory landscapes, competitive forces, and evolving healthcare trends. This analysis delineates key market drivers, challenges, and financial trajectories influencing Ultram ER's positioning and future prospects.

Pharmacological Profile and Therapeutic Use

Ultram ER contains tramadol, a centrally acting analgesic with opioid-like properties but classified as a Schedule IV controlled substance in the United States. Its extended-release formulation offers sustained analgesia for moderate to severe pain, improving patient compliance and reducing dosing frequency. The drug's dual mechanism—μ-opioid receptor agonism and inhibition of serotonin and norepinephrine reuptake—contributes to its efficacy, but also raises concerns about misuse, dependence, and adverse events.

Market Dynamics

1. Rising Chronic Pain Prevalence

Chronic pain affects approximately 20% of adults globally, with estimates reaching upwards of 50 million Americans suffering from persistent pain conditions [1]. The aging population and increased incidence of degenerative diseases drive demand for effective long-term analgesics. Ultram ER, positioned as a non-opioid alternative with a potentially lower risk profile, benefits from this growing need amidst opioid stewardship initiatives.

2. Regulatory Environment and Opioid Crisis Impact

The opioid epidemic has heavily influenced prescribing behaviors. Stricter regulations and heightened scrutiny over opioid prescriptions have affected sales of traditional opioids, creating a market void filled by alternatives like tramadol-based formulations. Regulatory agencies have issued guidelines emphasizing risk mitigation—such as mandatory REMS (Risk Evaluation and Mitigation Strategies)—which influence manufacturer distribution and marketing strategies [2].

3. Competitive Landscape

Ultram ER faces competition from several fronts:

• Generic Tramadol Extended-Release Products: Patent expirations have led to increased generic availability, intensifying price competition.
• Other Non-Opioid Analgesics: NSAIDs, anticonvulsants, and antidepressants remain alternatives for certain pain conditions.
• Emerging Technologies: Neuromodulation devices and novel analgesic agents are gradually entering the market, potentially reducing reliance on pharmacotherapy.

4. Patent and Exclusivity Status

The original formulation of Ultram ER was approved in 2004, with patent protections expiring in various jurisdictions over time. Patent lapses have led to a proliferation of generics, exerting downward pressure on prices and profit margins [3]. Nonetheless, proprietary formulations and delivery mechanisms may afford some exclusivity advantages.

5. Reimbursement and Prescriber Acceptance

Reimbursement policies significantly influence market access. Insurance coverage for Ultram ER generally aligns with coverage for similar pain medications, but cost-sharing and formulary placements impact prescribing patterns. Education campaigns targeting prescribers about Ultram ER's role can enhance acceptance, especially concerning safety and misuse potential.

Financial Trajectory

1. Revenue Trends

Initial revenues for Ultram ER reflected robust demand due to its profile as a non-injectable, extended-release opioid alternative. However, subsequent patent expirations and the influx of generics have caused revenues to plateau or decline. Despite this, companies with proprietary formulations or combination strategies have sustained margins.

2. Impact of Generic Competition

The entry of generics typically results in a 70–90% reduction in drug prices within two years of patent expiry, substantially shrinking profit margins [4]. For Ultram ER, this transition has likely compressed revenue streams, prompting innovation in drug delivery or formulation to sustain profitability.

3. Regulatory-Driven Market Expansion

New regulatory approvals—such as indications for specific pain syndromes—can stimulate sales. However, rising scrutiny over tramadol’s safety profile constrains aggressive marketing strategies. Some markets have introduced strict prescribing limitations, which dampen growth potential.

4. Market Penetration and Geographic Factors

Developing markets with limited access to opioids present opportunities for growth. Ultram ER's safety profile and ease of administration make it appealing in regions prioritizing pain relief with controlled substance regulation. Tailored pricing strategies and partnerships are essential to penetrate these markets effectively.

5. R&D and Pipeline Development

Investments in formulation enhancements—such as abuse-deterrent technologies—may offset declining revenue trends. Such innovations can preserve market share and appeal to regulatory agencies, potentially extending exclusivity periods.

Market Opportunities and Challenges

Opportunities

• Chronic Pain Management Innovation: Combining Ultram ER with adjunct therapies may broaden its therapeutic niche.
• Digital Health Integration: Monitoring adherence via digital tools can enhance data collection and patient outcomes.
• Regulatory Approvals for New Indications: Securing approvals for specific pain conditions can rejuvenate sales.

Challenges

• Safety and Abuse Concerns: High-profile misuse reports can impair public perception and regulatory access.
• Pricing Pressure: Generic competition and healthcare cost containment measures limit pricing flexibility.
• Market Saturation: The proliferation of generics leads to narrower margins and intense price competition.

Future Outlook

The financial trajectory of Ultram ER will predominantly depend on strategic innovation, regulatory navigation, and market expansion. While immediate revenues face pressure from generic competition, targeted efforts in abuse-deterrent formulations, expanded indications, and geographic diversification can sustain profitability. Long-term growth hinges on the drug's ability to adapt within an evolving pain management paradigm emphasizing safety, efficacy, and cost-effectiveness.

Key Takeaways

• The increasing prevalence of chronic pain and regulatory shifts favor non-opioid alternatives like Ultram ER, but market share is under intense pressure due to generic competition.
• Patent expirations have accelerated price erosion, necessitating innovation in formulation and delivery.
• Abuse-deterrent technologies and expanded indications are critical for maintaining competitive relevance.
• Geographic diversification and digital health integration provide avenues for market growth.
• Strategic alignment with evolving healthcare policies and prescriber education are essential to optimize the financial trajectory.

---

FAQs

1. How has the opioid crisis impacted Ultram ER’s market?
Regulatory focus on opioid misuse has increased scrutiny over tramadol, influencing prescribing patterns. However, Ultram ER’s lower misuse potential compared to traditional opioids presents opportunities as a safer alternative, yet market access remains constrained by tight regulations.

2. What role do patent expiries play in Ultram ER’s financial outlook?
Patent expiries lead to generic entry, significantly reducing prices and profit margins. Sustaining revenue requires innovation, such as abuse-deterrent formulations and new indications, to differentiate from generics.

3. Are there new regulatory hurdles for Ultram ER?
Yes. Agencies have implemented strict REMS programs and safety labeling updates due to concerns over misuse and adverse effects. Navigating these requirements demands continuous compliance efforts.

4. Can geographic expansion offset declining revenues?
Potentially. Developing markets with less stringent regulations and greater unmet pain management needs offer growth opportunities, provided appropriate pricing and partnerships are established.

5. What innovations could extend Ultram ER’s market viability?
Development of abuse-deterrent formulations, combination therapies, and expanded indications are pivotal. Additionally, integrating digital adherence support can enhance patient outcomes and market penetration.

---

Sources

[1] Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. The National Academies Press, 2011.
[2] U.S. Food and Drug Administration. FDA Drugs and Device Safety Notifications. October 2020.
[3] United States Patent and Trademark Office. Patent expiration timelines for tramadol formulations.
[4] IQVIA. Pharmaceutical Market Trends and Analysis, 2022.