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-two 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:	42
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	543
Patent Applications:	4,367
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRAMADOL HYDROCHLORIDE
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
University Tunis El Manar	NA
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	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
Janssen Pharms	ULTRAM	tramadol hydrochloride	TABLET;ORAL	020281-002	Mar 3, 1995		DISCN	Yes	No
Teva	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075977-001	Jun 19, 2002	AB	RX	No	No
Sun Pharm Inds Inc	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075964-001	Jun 19, 2002	AB	RX	No	No
Actavis Elizabeth	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	091609-001	Jun 27, 2012		DISCN	No	No

Expired US Patents for TRAMADOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shionogi Inc	RYBIX ODT	tramadol hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021693-001	May 5, 2005
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-003	Dec 30, 2008
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-001	Dec 30, 2008
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-003	Sep 8, 2005

International Patents for TRAMADOL HYDROCHLORIDE

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

Supplementary Protection Certificates for TRAMADOL HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for Tramadol Hydrochloride

Last updated: January 7, 2026

Executive Summary

Tramadol hydrochloride, a centrally acting analgesic, has experienced fluctuating market dynamics driven by regulatory scrutiny, patent status, and evolving healthcare policies. As a synthetic opioid with dual mechanisms—weak μ-opioid receptor agonism and inhibition of norepinephrine and serotonin reuptake—tramadol occupies a unique niche in pain management. This report explores the current market landscape, key drivers and barriers, financial trends, and future forecasts for tramadol hydrochloride, concluding with strategic insights for stakeholders.

Introduction: Overview of Tramadol Hydrochloride

Tramadol hydrochloride is approved for moderate to severe pain management. It was first marketed in the 1970s, with global sales peaking in the 2010s. It is marketed under various brand names, including Ultram, and available in immediate-release (IR) and extended-release (ER) formulations. The World Health Organization (WHO) categorizes tramadol as an essential medicine, yet regulatory frameworks differ widely.

---

Market Landscape and Key Players

Major Manufacturers	Global Market Share (%)	Key Generic Players	Regionally Dominant Brands
Janssen (Johnson & Johnson)	~30%	Mylan, Teva, Sandoz	Ultram (USA), Tramacet (Canada)
Grünenthal	~20%	Actavis, Lupin	Conzip (USA), Tramastat (Europe)
Other Generics	~50%	Multiple local players	Various regional brands

Source: MarketWatch, 2022

Market Segmentation

• By Drug Formulation: IR, ER, suppositories
• By End-User: Hospitals, outpatient clinics, retail pharmacies
• By Geography: North America (most mature), Europe, Asia-Pacific (fast-growing), Latin America, Africa

---

Key Market Drivers and Barriers

What Are the Major Drivers of Market Growth?

Drivers	Impact and Rationale
Growing Pain Management Demand	Aging populations and chronic pain prevalence expand usage globally.
Regulatory Approval and Off-Patent Status	Increased generic penetration reduces prices and boosts volume.
Healthcare Policies Favoring Non-Opioids	Shift towards safer analgesics in response to opioid crisis.
Economic Advantages of Generics	Cost-effective alternative to opioids like oxycodone and morphine.

What Are the Constraints and Challenges?

Barriers	Impact and Rationale
Regulatory Restrictions due to Abuse Potential	Stringent regulations limit prescribing and distribution in some markets.
COVID-19 Disruptions	Supply chain disturbances and reduced elective procedures decreasing demand.
Concerns over Safety and Misuse	Increased scrutiny and Controlled Substance Act classifications in certain regions.
Market Competition	Entry of novel analgesics (e.g., tapentadol) limits tramadol’s growth.

---

Financial Trajectory and Market Valuation

Historical Market Performance

Year	Global Sales (USD billion)	CAGR (2018-2022)	Notes
2018	1.2	–	Stabilized due to regulatory pressures.
2019	1.3	+8.33%	Mild growth, increased generic entry.
2020	1.1	-15.38%	COVID-19’s impact on demand.
2021	1.4	+27.27%	Recovery driven by healthcare resumption.
2022	1.5	+7.14%	Steady market penetration.

Source: IQVIA, 2023

Forecasts Through 2027

Year	Projected Sales (USD billion)	CAGR (2023-2027)	Key Assumptions
2023	1.6	+6.7%	Continued generic competition, stabilized demand.
2024	1.8	+12.5%	Regulatory easing in select markets, expanding use.
2025	2.0	+11.1%	Introduction of combination formulations.
2026	2.2	+10%	Integration into chronic pain management protocols.
2027	2.4	+9.1%	Market maturation, potential new formulations.

Note: CAGR calculated based on incremental growth; actual figures depend on policy shifts and new therapeutic alternatives.

Pricing Trends and Market Shares

Market Segment	Average Price (USD per unit)	Historical Trend	Future Outlook
Immediate-release (IR)	0.75	Slight decline with generics	Stable, competitive pricing
Extended-release (ER)	2.50	Stable to modest decline	Potential increase with new tech
Combination formulations	N/A	Limited data	Growth expected

Note: Price reductions due to patent expiry and increased competition.

---

Comparison with Other Pain Management Drugs

Drug	Mechanism	Market Share (2022)	Regulatory Status / Concerns	Notes
Oxycodone	Opioid receptor agonist	25%	High abuse potential, strict regs	Market share declining in US
Tramadol	Weak μ-opioid + reuptake inhib	15%	Safer profile, broader acceptance	Stable in Europe
Tapentadol	MU-opioid + norepinephrine reuptake	10%	Similar risks, newer entry	Growth potential
Gabapentin / Pregabalin	Anticonvulsants	20%	Off-label use, regulatory scrutiny	Growing in chronic pain

---

Regulatory Landscape and Patent Status

Global Variability in Regulations

Region	Classification	Restrictions	Impact
North America	Schedule IV (U.S.), controlled substance	Prescriptions limited; abuse monitoring tools	Moderate to high regulatory impact
Europe	Prescription-only in most countries	Strict control measures	Limits distribution, but accepted
Asia-Pacific	Varies (some over-the-counter sales)	Less regulatory oversight	Potential for market expansion
Latin America	Prescription-only in several countries	Growing regulatory framework	Moderate growth opportunities

Patent & Exclusivity Outlook

• Patent Expiry: Most key formulations expired globally circa 2015-2018.
• Regulatory Exclusivities: Reduced due to off-patent status; generic market dominates.
• Implication: Cost-driven, high-volume market with thin margins.

---

Market Opportunities and Future Outlook

Emerging Trends

• Generic Penetration: Continuous entry of generics accelerates volume but pressures prices.
• Combination Therapies: Increasing formulations combining tramadol with other analgesics (e.g., acetaminophen, NSAIDs).
• Digital and Monitoring Tools: Enhanced dispensing and adherence tracking.
• Alternative Delivery: Transdermal, implantable forms for chronic pain.

Potential Growth Drivers

• Chronic Pain Management: Aging populations and high prevalence of osteoarthritis and neuropathic pain.
• Expanding Markets: Focus on Asian and Latin American regions.
• Healthcare Policy Shifts: Push for non-opioid pain therapies due to misuse concerns.

Risks and Challenges

• Regulatory Restrictions: Potential reclassification or bans in some jurisdictions.
• Market Saturation: High generic competition limits pricing power.
• Safety Concerns: Rising reports of misuse may lead to tighter controls.
• Emerging Alternatives: Newer, possibly safer analgesics could supplant tramadol.

---

Comparison with Key Drugs in Pain Management

Attribute	Tramadol Hydrochloride	Oxycodone	Tapentadol	Gabapentin
Mechanism	Weak μ-opioid + serotonin/norepinephrine reuptake inhibitor	Strong μ-opioid receptor agonist	μ-opioid + norepinephrine reuptake	Anticonvulsant
Regulatory Control	Schedule IV (US), varied elsewhere	Schedule II (US)	Schedule II	Prescription-only
Abuse Potential	Moderate	High	Moderate	Low
Pricing (USD per unit)	0.75–2.50	2.00–5.00	3.00–6.00	0.50–1.00
Market Share (globally, 2022)	~15%	~25%	~10%	~20%

Sources: IQVIA, 2023; FDA classifications

---

Strategies for Stakeholders

Stakeholder	Recommended Action
Manufacturers	Invest in formulations improving safety, explore combination products, expand into emerging markets
Regulatory Bodies	Establish clear guidelines balancing access and abuse prevention
Healthcare Providers	Educate on appropriate usage, monitor for misuse, favor multimodal pain management techniques
Investors	Focus on companies with diversified analgesic portfolios and emerging combination therapies

---

Key Takeaways

• Market maturity and decline: Tramadol's global market faces stagnation due to regulatory constraints and high generic competition.
• Growth prospects: Expansion hinges on emerging markets, combination formulations, and chronic pain initiatives.
• Pricing pressures: Extensive generics increase volume but diminish profit margins.
• Regulatory environment: Variable policies necessitate adaptability; potential reclassification remains a risk.
• Strategic focus: Developers should innovate with formulations that emphasize safety and compliance, and expand into underserved territories.

---

FAQs

1. What is the primary driver for tramadol hydrochloride’s market changes?
   Increasing regulatory scrutiny due to misuse concerns and the expiration of patent protection are primary forces affecting supply and pricing.

2. How does tramadol compare to other opioids in safety profile?
   Tramadol is generally perceived as safer due to lower abuse potential than Schedule II opioids such as oxycodone, but concerns over misuse persist.

3. What forecasted trends could influence tramadol’s market in the next five years?
   Growth will likely depend on expanding access in emerging markets, formulation innovation, and integration into multimodal pain management strategies.

4. Are there significant regulatory barriers to tramadol’s distribution?
   Yes, especially in North America and parts of Europe, where classification and prescribing restrictions limit market expansion.

5. What is the outlook for generic manufacturers?
   Generic manufacturers are positioned to benefit from market saturation but need to navigate regulatory changes and price erosion.

---

References

[1] IQVIA. (2023). Global Pain Management Market Report.
[2] FDA. (2020). Controlled Substance Schedule and Regulations.
[3] WHO. (2019). Essential Medicines List.
[4] MarketWatch. (2022). Pharmaceutical Market Trends.