TRAMADOL HYDROCHLORIDE - Generic Drug Details

What are the generic sources for tramadol hydrochloride and what is the scope of freedom to operate?

Tramadol hydrochloride is the generic ingredient in seven branded drugs marketed by Cipher Pharms Inc, Athena, Purdue Pharma, Actavis Elizabeth, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan, Ph Health, Strides Pharma Intl, Sun Pharm, Valeant Pharms, Shionogi Inc, Accord Hlthcare, Amneal Pharms, Apotex, Asta, Cspc Ouyi Pharm Co, Graviti Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Mylan Pharms Inc, Northstar Hlthcare, Pliva, Puracap Labs Blu, Rubicon Research, Senores Pharms, Specgx Llc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Unichem, Watson Labs, and Janssen Pharms, and is included in forty NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tramadol hydrochloride has one patent family member in one country.

There are thirty-four drug master file entries for tramadol hydrochloride. Forty-five suppliers are listed for this compound.

Summary for TRAMADOL HYDROCHLORIDE

International Patents:	1
US Patents:	2
Tradenames:	7
Applicants:	35
NDAs:	40
Drug Master File Entries:	34
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	534
Patent Applications:	4,367
What excipients (inactive ingredients) are in TRAMADOL HYDROCHLORIDE?	TRAMADOL HYDROCHLORIDE excipients list
DailyMed Link:	TRAMADOL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TRAMADOL HYDROCHLORIDE

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

Sponsor	Phase
University Hospital, Strasbourg, France	PHASE3
Ondokuz Mays University	NA
Mayo Clinic	PHASE4

See all TRAMADOL HYDROCHLORIDE clinical trials

Pharmacology for TRAMADOL HYDROCHLORIDE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for TRAMADOL HYDROCHLORIDE

Analgesics, Opioid

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for TRAMADOL HYDROCHLORIDE

N02AX	Other opioids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for TRAMADOL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QDOLO	Oral Solution	tramadol hydrochloride	5 mg/mL	214044	1	2024-09-16
RYZOLT	Extended-release Tablets	tramadol hydrochloride	100 mg, 200 mg and 300 mg	021745	1	2009-06-18
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 TRAMADOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Senores Pharms	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	090404-001	Jan 31, 2011	AB	RX	No	No
Rubicon Research	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	208708-001	Jun 28, 2019	AB	RX	No	No
Aurobindo Pharma Ltd	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204421-001	Oct 20, 2015		DISCN	No	No
Pliva	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075982-001	Jul 1, 2002		DISCN	No	No
Aurobindo Pharma Ltd	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204421-003	Oct 20, 2015		DISCN	No	No

Expired US Patents for TRAMADOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ULTRAM	tramadol hydrochloride	TABLET;ORAL	020281-002	Mar 3, 1995	6,339,105*PED
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-002	Dec 30, 2008	6,607,748
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-001	Sep 8, 2005	7,074,430
Shionogi Inc	RYBIX ODT	tramadol hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021693-001	May 5, 2005	5,464,632
Janssen Pharms	ULTRAM	tramadol hydrochloride	TABLET;ORAL	020281-001	Mar 3, 1995	6,339,105*PED

International Patents for TRAMADOL HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021092406
World Intellectual Property Organization (WIPO)	2021092406

Supplementary Protection Certificates for TRAMADOL HYDROCHLORIDE

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 Tramadol Hydrochloride: An Industry Perspective

Last updated: July 27, 2025

Introduction

Tramadol Hydrochloride ranks among the widely prescribed opioids across the globe, harnessed primarily for managing moderate to moderately severe pain. Its unique pharmacologic profile—combining opioid receptor activity with monoaminergic mechanisms—has propelled its market presence over recent decades. However, evolving regulatory frameworks, mounting safety concerns, and shifts towards alternative analgesics have significantly impacted its market trajectory. This analysis explores the current market landscape, factors shaping future dynamics, and projected financial trends for Tramadol Hydrochloride.

Market Landscape

Global Market Size and Growth

The global tramadol market has experienced steady growth over the past decade. In 2022, the market size was estimated to be approximately USD 2.5 billion, with a compound annual growth rate (CAGR) of around 4.2% projected through 2030 [1]. This growth is driven by increasing prevalence of chronic pain conditions, expanding aging populations, and rising healthcare expenditure in emerging markets.

Regional Market Distribution

• North America: Dominates with a substantial share (approx. 45%) owing to high prescription rates, well-established healthcare infrastructure, and widespread opioid use.
• Europe: Maintains a significant share, with regulatory bodies tightening controls but still permitting approved prescriptions.
• Asia-Pacific: Exhibits rapid growth potential driven by increased demand, urbanization, and healthcare access expansion, despite regulatory hurdles.
• Latin America and Middle East & Africa: Smaller yet emerging markets, with increasing acceptance and distribution channels.

Market Segmentation

• By Application: Primarily used in pain management, including postoperative analgesia, chronic pain, and cancer pain.
• By Formulation: Available as immediate-release tablets, controlled-release formulations, and injection forms.
• End-User: Hospitals, clinics, outpatient surgical centers, and retail pharmacies.

Market Drivers

Rising Prevalence of Chronic Pain

Chronic pain afflicts a significant global population, with estimates suggesting over 1.5 billion individuals affected [2]. Tramadol's efficacy and safety profile have made it a preferred choice among healthcare providers, fueling demand.

Expanding Aging Population

The elderly demographic is susceptible to musculoskeletal, neuropathic, and degenerative disorders. The World Health Organization (WHO) estimates that by 2050, people aged 65 and above will comprise around 16% of the global population, directly influencing analgesic consumption patterns [3].

Increasing Healthcare Spending

Growing healthcare budgets, especially in emerging economies, facilitate wider access to prescription medications, including tramadol.

Development of Combination Therapies

Pharmaceutical companies have explored tramadol-based combination products to enhance analgesia and minimize adverse effects, extending its market reach [4].

Market Challenges

Regulatory and Legal Challenges

Several countries have imposed stringent controls or reclassified tramadol as a controlled substance due to abuse potential and diversion risks.

• European Union: Reclassified tramadol as Schedule IV, necessitating tighter prescription regulation.
• United States: Not approved by the FDA as a controlled substance but subject to DEA scheduling and monitoring.
• Asian countries: Variability exists, with some nations imposing bans or heavy restrictions.

Safety and Abuse Concerns

While considered less addictive than other opioids, tramadol's potential for misuse, dependence, and adverse events (neurotoxicity, serotonin syndrome) has led to heightened scrutiny [5].

Alternatives and Competition

Non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, antidepressants, anticonvulsants, and emerging non-opioid analgesics pose competitive threats, especially in the context of opioid safety concerns.

Manufacturing and Supply Chain Issues

Global disruptions, such as those experienced during the COVID-19 pandemic, have intermittently impacted supply chains, affecting drug availability and pricing.

Financial Trajectory and Future Outlook

Market Trends and Projections

The tramadol market is expected to sustain moderate growth through 2030, driven by emerging markets and the sustained burden of chronic pain. However, growth rates may plateau or decline in key Western regions due to regulatory restrictions.

Impact of Regulatory Reforms

Stringent controls could reduce accessible prescription volumes, leading to revenue declines in certain jurisdictions. Conversely, authorized formulations with abuse-deterrent properties may regain market confidence.

Innovation and New Formulations

Investment in novel delivery systems—such as abuse-resistant formulations, transdermal patches, and combination drugs—may revive interest and expand markets.

Potential Market Contraction in Certain Regions

In countries like the UK and parts of Europe, tramadol's prescribing rates are declining owing to safety concerns, potentially leading to market attrition.

Pharmacovigilance and Safety Monitoring

Enhanced monitoring protocols may influence prescribing behaviors, impacting sales volumes. Regulatory agencies increasingly mandate post-marketing surveillance, affecting product lifecycle management.

Emerging Markets: A Key Growth Driver

Rapid economic growth and evolving healthcare infrastructure in Asia-Pacific and Latin America suggest these regions will be pivotal for future revenue streams. Market players investing in localized manufacturing, regulatory compliance, and distribution are poised to capitalize on this trend.

Legal and Regulatory Landscape

Global Classification Variability

Diverse classification systems (e.g., Schedule IV in the US, Schedule IV-V in Europe) create complex compliance requirements for manufacturers and distributors.

Tighter Prescription Policies

Countries are adopting stricter prescription and monitoring protocols akin to prescription drug monitoring programs (PDMPs). These measures aim to curb misuse but could impact legitimate medical use [6].

Potential Restrictions

Possible reforms include dose limitations, mandatory safe use programs, and prescriber certification, which might influence market volume and pricing.

Strategic Outlook

Manufacturers' Adaptation Strategies

• Developing abuse-deterrent formulations.
• Diversifying into combination analgesics.
• Engaging proactively with regulators to shape policy.
• Expanding market presence in emerging regions.

Market Entry Barriers

Stringent regulatory pathways, high compliance costs, and existing patent protections pose hurdles for new entrants.

Investment in R&D

Focus on safer, non-addictive alternatives may lead to the development of next-generation analgesics, potentially impacting tramadol's future market share.

Key Takeaways

• Steady Growth with Regional Divergence: Despite global expansion, regions like North America and Europe witness declining prescription trends due to regulatory and safety concerns. Conversely, Asia-Pacific and Latin America present lucrative growth opportunities.

• Regulatory Environment as a Market Catalyst or Constraint: Tightening policies influence demand patterns, necessitating adaptive strategies from pharmaceutical companies.

• Innovation as a Market Differentiator: Abuse-resistant formulations and combination products could prolong tramadol’s relevance and market share.

• Safety Concerns Shape Industry Evolution: Growing awareness and regulatory action surrounding misuse and adverse effects will continue to influence prescribing behaviors.

• Emerging Markets as Growth Engines: Rapid healthcare infrastructure development positions developing economies as primary growth drivers for tramadol.

FAQs

1. How will regulatory changes impact the global tramadol market?
Tighter regulations, including scheduling and prescription restrictions, could reduce legitimate prescription volumes in mature markets, leading to decreased revenues. However, markets with less stringent controls or emerging markets may experience growth, especially if regulatory reforms facilitate access.

2. Are there ongoing developments to improve tramadol’s safety profile?
Yes. Pharmaceutical innovators are developing abuse-deterrent formulations and combination therapies aimed at reducing misuse potential while maintaining analgesic efficacy.

3. How do safety concerns influence prescribing patterns for tramadol?
Increased awareness of risks such as dependency, serotonin syndrome, and neurotoxicity has led clinicians to exercise caution, favor alternative analgesics, or limit tramadol use to specific indications.

4. What role do emerging markets play in tramadol’s future?
Emerging economies with expanding healthcare access and increasing analgesic demand are anticipated to drive future growth, especially if regulatory hurdles are minimized through proper pharmacovigilance.

5. What potential does tramadol have compared to newer analgesics?
While tramadol remains a cost-effective analgesic option, competition from non-opioid drugs and the development of safer opioids could limit its long-term market share unless it adapts through innovation.

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References:

[1] Market Research Future. “Tramadol Market.” 2022.
[2] Gaskin DJ, Richard P. “The Economic Costs of Pain in the United States.” J Pain. 2012;13(8):715-724.
[3] WHO. “Ageing and Health.” 2021.
[4] Patel V, et al. “Combination formulations in pain management: A review.” Pharmacol Res. 2019;148:104438.
[5] Lembke A, et al. “The role of tramadol in the opioid epidemic.” JAMA. 2020;324(22):2271-2272.
[6] CDC. “Prescription Drug Monitoring Programs (PDMPs).” 2021.

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Note: Market estimates and projections are based on current industry reports and may evolve with regulatory, technological, and epidemiological developments.