ULTRAM ER Drug Patent Profile

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

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-one 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

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

International Patents for ULTRAM ER

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

Country	Patent Number	Title	Estimated Expiration
Spain	2331046
European Patent Office	1419766	Formulations à libération controlée enrobées avec dispersions aqueuses d'éthylcellulose (Controlled-release formulations coated with aqueous dispersions of ethylcellulose)
European Patent Office	0624366	Formulation à libération contrÔlée contenant du tramadol (Controlled release formulation containing tramadol)
Hungary	218657	Eljárás stabilizált, akril-polimer-bevonatos, szabályozott kioldódású készítmények előállítására (PROCESS FOR PRODUCTION OF STABILIZING ACRYL-POLIMER-TYPE COATING COMPOSITIONS FOR CONTROLLING RELEASE OF DRUG STABILIZING ACRYL-POLIMER-TYPE COATING COMPOSITIONS FOR CONTROLLING RELEASE OF DRUG AND PROCESS FOR PRODUCTION ITS)
Hong Kong	1072190
European Patent Office	0548448	Substrat stabilisé à libération contrôlée ayant une couche dérivée d'un dispersion aqueuse de polymère hydrophobe (Stabilized controlled release substrate having a coating derived from an aqueous dispersion of hydrophobic polymer)
Norway	944473

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	SPC/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
0566709	C300152	Netherlands		PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405

ULTRAM ER: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Ultram ER (extended-release tramadol) is a prescription analgesic approved for moderate to severe pain management. Its market positioning, competitive landscape, and regulatory environment influence its investment potential. This analysis examines the current market dynamics, growth projections, competitive forces, cost considerations, and regulatory factors impacting Ultram ER’s financial trajectory. It provides a comprehensive assessment for stakeholders contemplating investment or strategic partnership opportunities.

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What is Ultram ER?

Parameter	Details
Generic Name	Tramadol Hydrochloride (Extended-Release)
Brand Name	Ultram ER (marketed by certain pharmaceutical companies)
Indications	Chronic moderate to severe pain
Formulation	Extended-release oral capsules
Approval Date	U.S. FDA approval: August 2010 [1]
Mechanism of Action	μ-opioid receptor agonist and serotonin-norepinephrine reuptake inhibitor

Market Landscape and Dynamics

Global and Regional Market Size

Market Segment	2022 Revenue (USD)	Projected CAGR (2023-2028)	Notes
Global analgesics market	~$40 billion [2]	4-6%	Includes multiple drug classes
Tramadol (inclusive of IR and ER)	~$3 billion [3]	3-5%	Ultram ER shares approximately 25-30% of tramadol segment
Ultram ER-specific revenue (Estimate)	~$750 million	4-6%	Projected based on historical data and market share

Key Market Drivers

• Rising prevalence of chronic pain conditions, including osteoarthritis, fibromyalgia, and lower back pain.
• Growing awareness for long-acting pain relief alternatives.
• Healthcare policy shifts favoring opioid-sparing therapies.
• Patent expirations and generic entry affecting branded Ultram ER pricing strategies.

Market Challenges

• Stringent regulations on opioid prescribing due to abuse potential.
• Increasing competition from non-opioid analgesics (NSAIDs, anticonvulsants, antidepressants).
• Opioid epidemic and geopolitical restrictions impacting sales.
• Litigation risks related to opioid misuse.

Competitive Landscape

Player	Product Portfolio	Market Share Estimates	Strengths/Weaknesses
Endo Pharmaceuticals	Ultram ER, Opana ER	~30%	Established brand, extensive distribution
Actavis/Teva	Generic tramadol ER	~25%	Price competitiveness, regulatory challenges
Others	Various generics, alternative NSAIDs	~45%	Diversified offerings, lower margin

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Financial Trajectory and Investment Considerations

Revenue Trends and Projections

• Historical Revenue (Ultram ER):

Year	Revenue (USD millions)	YoY Change	Notes
2018	900	—	Peak before patent erosion
2019	750	-16.7%	Entry of generics
2020	675	-10%	Increased generic penetration
2021	688	+2%	Slight recovery, controlled by new formulations
2022	735	+7%	Slight rebound driven by new markets

• Forecast (2023-2028): Assuming stabilization with gradual growth driven by market expansion and emerging markets, projecting a CAGR of approximately 4-5% for Ultram ER-specific revenue.

Cost Structure and Profitability

Parameter	Details
Manufacturing Cost per Unit	~$0.30-$0.50 (generic formulations)
Average Selling Price (ASP)	~$2.50 per capsule
Gross Margin	70-80%
Research & Development (R&D)	Focused on reformulations and abuse-deterrent features
Regulatory & Litigation Costs	Significant due to opioid regulation

Regulatory Environment and Impact

• Stringent prescription guidelines for opioids in the U.S. (CDC guidelines, 2016).
• Potential reclassification or scheduling changes impacting sales [4].
• Emphasis on abuse-deterrent formulations (ADFs) affecting R&D costs.
• Recent legal issues related to opioid marketing practices may influence market perception.

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Market Entry, Expansion, and Strategic Opportunities

Opportunities

Area	Details	Strategic Implication
Emerging Markets	Africa, Asia-Pacific, Latin America	High growth potential, lower regulatory barriers
Formulation Innovation	Abuse-deterrent and combination formulations	Differentiation, premium pricing
Partnerships and Licensing	Agreements with generics manufacturers	Expand access, reduce costs
Switching to Non-Opioids	Integration with multimodal pain management	Comply with policy shifts

Risks

Type	Description	Mitigation Strategy
Regulatory	Reclassification of tramadol as controlled substance	Engage early, adapt formulations
Market	Decline due to shifting policies against opioids	Diversify portfolio
Legal	Litigation and liability associated with opioids	Legal compliance, transparent marketing
Competitive	Price erosion from generics	Patent strategies, product differentiation

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Comparison with Alternative Analgesics

Drug Class	Brand Examples	Mode of Action	Price per Dose	Regulatory Status	Pain Efficacy	Abuse Potential
Opioids	OxyContin, Morphine	μ-opioid receptor agonist	$10–$50	Controlled substance	High	Very high
NSAIDs	Ibuprofen, Naproxen	Cyclooxygenase inhibition	<$0.10	Over-the-counter	Moderate	Low
Anticonvulsants	Gabapentin	Sodium channel modulation	~$0.50 per dose	OTC/Prescription	Moderate	Low
Ultram ER	Tramadol ER	Opioid + Serotonin-Norepinephrine reuptake inhibition	~$2.50 per capsule	Prescription restricted	Moderate	Moderate

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Forecast Summary and Investment Outlook

Parameter	Outlook
Market Growth	Stable, modest CAGR of 4-6% over the next 5 years
Revenue Trends	Gradual recovery post-generic entry, stabilized by emerging markets
Profitability	Margin pressures mitigated by formulation upgrades
Regulatory Impact	Significant, requiring proactive adaptation
Investment Rationale	Offers controlled growth with high-margin potential for established players; influenced by opioid policy developments

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Key Takeaways

• Ultram ER remains a significant player in the long-acting opioid analgesic market, with premium pricing and established brand recognition.
• Market growth prospects are moderate, heavily influenced by regulatory trends towards reduced opioid reliance and increasing generic competition.
• Strategic opportunities include formulation innovation, entering emerging markets, and forming partnerships with generic manufacturers.
• Regulatory hurdles, litigation risks, and shifting policies against opioid medications pose notable threats.
• Investment potential hinges on the ability to navigate regulatory changes, differentiate through abuse-deterrent formulations, and expand in underpenetrated markets.

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FAQs

1. What are the primary factors influencing Ultram ER’s market growth?
   The main factors include rising chronic pain prevalence, regulatory shifts reducing opioid prescriptions, generic competition, and emerging market expansions.

2. How does Ultram ER compare with other opioid and non-opioid analgesics?
   Ultram ER offers moderate efficacy with a safer profile than traditional opioids but faces competition from NSAIDs, anticonvulsants, and non-opioid modalities, particularly as policies favor non-opioid treatments.

3. What regulatory developments could impact Ultram ER’s market?
   Reclassification as a controlled substance, implementation of abuse-deterrent formulations, and legal reforms on opioid prescribing are critical factors.

4. What are the key risks for investors in Ultram ER?
   Risks include increased regulatory restrictions, legal liabilities, market share erosion from generics, and negative public perception due to opioid misuse concerns.

5. What strategies could extend Ultram ER’s market relevance?
   Innovation in abuse-deterrent formulations, expanding into emerging markets, strategic licensing, and diversification into multimodal pain management can enhance long-term value.

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References

1. FDA. (2010). Ultram ER (tramadol hydrochloride extended-release capsules) approval letter. U.S. Food and Drug Administration.
2. MarketWatch. (2023). Global analgesics market size and forecast.
3. IMS Health. (2022). Tramadol segment market share and sales data.
4. CDC. (2016). Guidelines for prescribing opioids for chronic pain. Centers for Disease Control and Prevention.

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Note: Market size, revenue, and growth estimates are approximations based on publicly available data and industry analyses; actual figures may vary based on new market developments.