celecoxib; tramadol hydrochloride - Profile

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What are the generic drug sources for celecoxib; tramadol hydrochloride and what is the scope of patent protection?

Celecoxib; tramadol hydrochloride is the generic ingredient in one branded drug marketed by Kowa Pharms and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Summary for celecoxib; tramadol hydrochloride

International Patents:	107
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for celecoxib; tramadol hydrochloride

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for celecoxib; tramadol hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No	10,238,668		Y	Y
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No	10,548,909
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No	11,478,488
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No	8,846,744		Y

International Patents for celecoxib; tramadol hydrochloride

Country	Patent Number	Title	Estimated Expiration
Argentina	079008
Australia	2009304235
Australia	2010306168
Brazil	112012005011

Supplementary Protection Certificates for celecoxib; tramadol hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0731795	10075033	Germany		PRODUCT NAME: CELECOXIB; NAT. REGISTRATION NO/DATE: 48802.00.00 20000518; FIRST REGISTRATION: SE 14838 19991203
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

Last updated: February 3, 2026

What Is the Market Overview for Celecoxib and Tramadol Hydrochloride?

Celecoxib (marketed as Celebrex) and tramadol hydrochloride are both widely prescribed pain management drugs with different mechanisms and market dynamics. Celecoxib, a selective COX-2 inhibitor, is primarily used for osteoarthritis, rheumatoid arthritis, and acute pain. Tramadol hydrochloride is a centrally acting opioid analgesic prescribed for moderate to severe pain. Both drugs hold significant market positions globally, with combined sales exceeding $7 billion in 2022.

What Are the Key Regulatory and Patent Statuses?

Celecoxib

• Patents: The original patent expired in 2014 in the US. Several formulations and combinations remain under patent; new indications and bioequivalent versions continue to be protected.
• Regulatory Approvals: Approved in over 100 countries. The FDA approved it in 1998.
• Patent Litigation: The patent for Celecoxib was challenged by generic manufacturers starting in 2011, leading to multiple approvals of generics post-2014.

Tramadol Hydrochloride

• Patents: Tramadol's basic patent expired around 2008 globally. Multiple extended patents existed on formulations, combinations, and delivery methods.
• Regulatory Approvals: Approved in over 80 countries, with significant markets in the US, EU, and Asia.
• Generic Competition: Entry of generics increased sharply post-patent expiry, affecting pricing and market share.

How Do Market Trends Affect Investment Opportunities?

Growth Drivers

• Increasing Chronic Pain Prevalence: Rising aging populations and lifestyle factors boost demand.
• Emerging Markets: Expansion in Asia-Pacific and Latin America provides new growth avenues.
• Product Diversification: Development of combination drugs and new formulations extends lifecycle.

Challenges

• Generic Competition: Patent expirations lead to pricing pressure.
• Regulatory Risks: Potential regulatory actions concerning cardiovascular and CNS safety profiles may impede marketability.
• Opioid Regulation: Tramadol, being an opioid, faces increasing regulation concerning misuse and dependency concerns.

Market Size and Forecasts

Drug	2022 Global Sales	Compound Annual Growth Rate (2023–2028)	Key Markets
Celecoxib	~$3.2 billion	~2.5%	US, Europe, Japan
Tramadol Hydrochloride	~$4.1 billion	~3.0%	US, EU, China

Source: IQVIA ([1])

What Are the Investment and R&D Fundamentals?

Patent and Lifecycle Management

• Companies focus on new formulations, fixed-dose combinations, and extending patent protection through new indications.
• Patent litigations and exclusivity periods influence short-term revenues.

Clinical Development

• New indications such as cancer-related pain or inflammatory conditions for celecoxib are under investigation, which could extend market life.
• For tramadol, safety concerns have prompted development of abuse-deterrent formulations.

Manufacturing and Supply Chain

• Quality control, especially for generic versions, significantly impacts profitability.
• Supply chain disruptions can influence pricing and market access in emerging economies.

Competitive Landscape and Market Share

Major Companies	Products	Market Share (Estimated)	Strategic Focus
Pfizer (Celecoxib)	Celebrex	~20%	Product renewal, new formulations
Grünenthal, MundiPharma (Tramadol)	Tramadol generics	~30%	Cost reduction, safety management

Investment Outlook Summary

• Biosimilar and generic threats pose risks to revenue.
• Diversification into new indications, formulations, or delivery systems presents growth opportunities.
• Regulatory risks remain a concern, especially with CNS and cardiovascular safety profiles.

What Are the Key Risks and Opportunities?

Risks

• Regulatory restrictions or withdrawals due to safety concerns.
• Patent litigation and patent cliff effects.
• Price erosion driven by generics.
• Regulatory and societal scrutiny around opioids.

Opportunities

• Development of new formulations with abuse-deterrent properties.
• Expansion into indication-specific markets like oncology pain.
• Growth in emerging markets with increasing healthcare expenditure.

Key Takeaways

• Celecoxib and tramadol hydrochloride remain significant revenue sources but face patent expirations and increased generic competition.
• Market growth hinges on aging populations, chronic pain management needs, and emerging markets expansion.
• Safety concerns and regulatory actions influence market dynamics, especially for opioids.
• Innovation in formulations and indications can extend product lifecycles.
• Companies prioritize lifecycle management strategies to offset patent expirations.

Frequently Asked Questions

1. What factors most influence the market values of celecoxib and tramadol?
   Market values are driven by patent status, safety profiles, regulatory approvals, competition, and emerging indications.

2. How do patent expirations impact revenue streams for these drugs?
   Patent expirations typically lead to a sharp decline in branded sales as generic competitors enter, forcing price reductions and market share loss.

3. Are there emerging alternatives to both drugs?
   Yes. Newer NSAIDs, biologics for inflammatory diseases, and non-opioid painkillers are being developed, which could substitute or reduce demand for celecoxib and tramadol.

4. What regulatory trends could affect future sales?
   Increased regulation of opioids due to abuse potential and safety concerns, and stricter guidelines for NSAID safety, could restrict or modify market access.

5. How can companies extend the lifecycle of these drugs?
   Through new formulations, combination therapies, approval for additional indications, and pursuing patent extensions via methodological innovations.

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Sources:

[1] IQVIA, "Global Pharmaceutical Market Data," 2022.