Celecoxib; tramadol hydrochloride - Generic Drug Details

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.

Celecoxib; tramadol hydrochloride has one hundred and seven patent family members in thirty-six countries.

Summary for celecoxib; tramadol hydrochloride

International Patents:	107
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	24
DailyMed Link:	celecoxib; tramadol hydrochloride at DailyMed

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.

Recent Clinical Trials for celecoxib; tramadol hydrochloride

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

Sponsor	Phase
Beijing Tiantan Hospital	NA
Washington University Institute of Clinical and Translational Sciences	PHASE4
The Foundation for Barnes-Jewish Hospital	PHASE4

See all celecoxib; tramadol hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for celecoxib; tramadol hydrochloride

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

M01AH	Coxibs
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

N02AX	Other opioids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

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			Y	Y
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No			Y
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No			Y	Y
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No			Y	Y
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No			Y	Y
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No

International Patents for celecoxib; tramadol hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	5800016
Japan	2013507402
New Zealand	591873
South Korea	101471585
Hungary	E030976
European Patent Office	2586432
Japan	2013530952

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

Market Dynamics and Financial Trajectory for Celecoxib and Tramadol Hydrochloride

Last updated: February 15, 2026

Overview
Celecoxib and tramadol hydrochloride are both widely used analgesic and anti-inflammatory drugs, with distinct market profiles driven by therapeutic indications, patent statuses, regulatory landscapes, and competitive forces.

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What Are the Market Drivers for Celecoxib and Tramadol Hydrochloride?

Celecoxib

• Indicated primarily for osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute pain.
• Market growth driven by aging populations and increasing incidence of chronic pain conditions.
• Patent expiration in key markets (e.g., US in 2014) led to a surge in generic availability, reducing revenue for originators.
• Usage raised concerns over cardiovascular risks, leading to product labeling updates and influencing prescribing patterns.

Tramadol Hydrochloride

• Approved for moderate to severe pain; used extensively across outpatient and inpatient settings.
• Market expansion affected by rising opioid misuse concerns and regulatory restrictions.
• Patent statuses vary; some formulations are generic, pressuring brand-name revenues.
• Incorporation into combination therapies and immediate-release formulations widened its market footprint.

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How Do Regulatory and Patent Landscapes Affect Market Dynamics?

Aspect	Celecoxib	Tramadol Hydrochloride
Patent Status	Original patent expired in multiple regions (e.g., US 2014)	Many formulations are off-patent, with some proprietary extended-release versions
Regulatory Restrictions	Labels warn of cardiovascular risks; contraindications limit prescribing	Increasing regulation on opioids affects prescribing; risk mitigation measures adopted
Market Entry Barriers	Generic manufacturers hold significant market share post-patent expiry	Defensive patent strategies for new formulations; generics dominate market

Impact:
The expiry of patents for celecoxib significantly decreased sales for originators but opened opportunities for generics, which now command a large share. Conversely, tramadol has been affected more by regulatory restrictions than patent issues, constraining growth potential despite high volume.

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What Are the Recent Trends in Market Size and Revenue?

Year	Celecoxib Market Size (USD billion)	Tramadol Market Size (USD billion)	Notes
2018	1.2	1.8	Based on global sales, with celecoxib's decline offset by generic competition; tramadol's growth slowed due to regulations.
2020	1.1	1.7	Market contraction for celecoxib; stable to slight decline for tramadol.
2022	1.0	1.6	Further saturation; stricter prescribing guidelines influence volume.

Projection:
The overall market for celecoxib is expected to decline at a compound annual growth rate (CAGR) of around 2% from 2023 to 2028. Tramadol's market is projected to mature, with a CAGR near 1%, reflecting regulatory headwinds and substitution by other analgesics.

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What Are the Key Factors Influencing Future Financial Trajectories?

• Patent Status and Generic Competition: The expiration of celecoxib patents caused revenue declines; ongoing patent protections for newer tramadol formulations could sustain higher price points, but market saturation limits upside.
• Regulatory Climate: Stricter opioid regulations worldwide (e.g., US CDC guidelines in 2016, EU restrictions) inhibit tramadol sales growth. Celecoxib's cardiovascular warnings restrict its use in certain patient populations.
• Healthcare Policy Trends: Moves toward opioid-sparing pain management and preference for non-steroidal anti-inflammatory drugs (NSAIDs) influence tramadol's volume.
• Market Penetration of Alternatives: Drugs like meloxicam, naproxen, and non-drug modalities (e.g., physical therapy) compete with celecoxib and tramadol.

How Do Competitive Strategies Shape Market Outcomes?

• Brand vs. Generic Market Share: Generic versions dominate celecoxib’s market post-patent expiry, capping revenue.
• Product Innovation: Slight modifications, such as extended-release tramadol, aim to extend patent life and premium pricing, but face regulatory challenges.
• Pricing Strategies: Discounts and formulary preferences significantly affect revenue, especially in managed care settings.

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Summary of Financial Trajectories

• Celecoxib: Historically peaked at around USD 1.2 billion in global sales pre-patent expiry; now predominantly generics, with annual sales declining toward USD 500-600 million in mature markets. Future growth limited by safety concerns and generic competition.
• Tramadol Hydrochloride: Maintains a solid volume of sales, approximately USD 1.5-1.6 billion globally; growth hampered by regulatory restrictions, with revenue expected to stabilize or decline marginally.

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Key Takeaways

• Patent expiries sharply reduced original celecoxib revenues, making generics the main market share holders.
• Regulatory restrictions on opioids, including tramadol, constrict growth and influence prescribing behavior.
• Market size for both drugs is stabilizing, with slow decline expected for celecoxib and plateau for tramadol.
• Innovations like combination therapies or extended-release formulations face regulatory hurdles that can delay or inhibit growth.
• Competitive pressures from newer NSAIDs and changes in pain management paradigms further shape future trajectories.

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FAQs

1. What are the main factors that have caused the decline of Celecoxib sales?
Patent expiry, safety concerns (cardiovascular risks), and a shift towards generic consumption have driven sales downward.

2. How do regulatory restrictions impact Tramadol’s market?
They limit prescribing, especially for higher doses and extended-release forms, reducing growth prospects despite high demand.

3. Are there ongoing patent protections for newer formulations of celecoxib and tramadol?
Most original patents for celecoxib expired by 2014. Some tramadol formulations, such as extended-release versions, may have active patents but face regulatory challenges.

4. What competitive strategies could sustain revenue for these drugs?
Product differentiation via new formulations, expanded indications, or improved safety profiles. However, regulatory approval remains a key barrier.

5. Which regions have the largest markets for celecoxib and tramadol?
North America remains dominant, followed by Europe and Asia-Pacific, where aging populations and pain prevalence are higher.

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Sources:
[1] IQVIA, "Global Analgesics Market Report," 2022.
[2] U.S. FDA, "Drug Approvals and Patent Data," 2022.
[3] MarketWatch, "Celecoxib Market Trends," 2023.
[4] WHO, "Global Pain Management Report," 2021.