CELECOXIB; TRAMADOL HYDROCHLORIDE - Generic Drug Details

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

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 five patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for CELECOXIB; TRAMADOL HYDROCHLORIDE

International Patents:	105
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	22
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
Henry Ford Health System	Phase 4
Addpharma Inc.	Phase 1
Lawson Health Research Institute	Phase 4

See all CELECOXIB; TRAMADOL HYDROCHLORIDE clinical trials

Pharmacology for CELECOXIB; TRAMADOL HYDROCHLORIDE

Drug Class	Nonsteroidal Anti-inflammatory Drug Opioid Agonist
Mechanism of Action	Cyclooxygenase Inhibitors Full Opioid Agonists

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
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

International Patents for CELECOXIB; TRAMADOL HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
New Zealand	603457	Pharmaceutical compositions of co-crystals of tramadol and coxibs
Portugal	2575778
San Marino	T201300048	Cocristalli di tramadol e inibitori della cox-2

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

CELECOXIB; TRAMADOL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Celecoxib and Tramadol Hydrochloride

Introduction to Celecoxib and Tramadol Hydrochloride

Celecoxib and Tramadol Hydrochloride are two significant medications in the pharmaceutical industry, each addressing different aspects of pain management.

• Celecoxib: A COX-2 selective nonsteroidal anti-inflammatory drug (NSAID) primarily used to treat pain, inflammation, and stiffness caused by osteoarthritis, rheumatoid arthritis, and other conditions[1][3][5].
• Tramadol Hydrochloride: An opioid analgesic used to treat moderate to moderately severe pain in adults, available in various formulations including immediate-release, extended-release, and combination therapies[2][4].

Market Size and Forecast

Celecoxib Market

• The global Celecoxib market was valued at USD 1.64 billion in 2023 and is projected to reach USD 2.87 billion by 2031, growing at a CAGR of 8.8% during the forecast period 2024-2031[1].
• Another estimate suggests the market will reach USD 3.1 billion by 2032, with a CAGR of 8.7%[3].

Tramadol Hydrochloride Market

• The Tramadol market was valued at USD 5.26 billion in 2022 and is expected to reach USD 7.29 billion by 2030, growing at a CAGR of 4.41% from 2023 to 2030[2].
• Alternatively, the market size was valued at USD 4.24 billion in 2023 and is projected to grow at a CAGR of 6.86%, reaching nearly USD 6.75 billion by 2030[4].

Drivers of Market Growth

Celecoxib

• Increasing Healthcare Expenditure: Global increases in healthcare spending driven by population growth, technological advancements, and enhanced healthcare infrastructure facilitate broader access to medications like Celecoxib[1].
• Regulatory Approvals: The approval of Celecoxib for additional indications or formulations by regulatory authorities can act as a significant market driver, enhancing its visibility and creating new opportunities[1].
• Chronic Pain Prevalence: The increasing need to treat osteoarthritis and acute pain drives the demand for Celecoxib[3].

Tramadol Hydrochloride

• Chronic Pain Prevalence: The growing prevalence of chronic pain, particularly among the aging population, is a key driver of the Tramadol market[2][4].
• Advancements in Drug Formulations: Innovations in drug delivery systems, such as extended-release formulations and combination therapies, improve patient compliance and efficacy, boosting demand for Tramadol[4].
• Regulatory Approvals and Awareness: Expanding regulatory approvals and growing awareness among patients and healthcare providers about pain management options contribute to market growth[4].

Restraints and Challenges

Celecoxib

• Generic Alternatives: The increasing market presence of generic alternatives poses a significant restraint on Celecoxib sales, as generic versions are often cheaper and more accessible[1].
• Pricing Pressure: Healthcare cost-containment measures and increased scrutiny on drug pricing lead to significant pricing pressure, eroding profit margins for manufacturers[1].
• Adverse Effects and Safety Concerns: Safety concerns, including cardiovascular risks associated with COX-2 inhibitors, can limit the widespread adoption of Celecoxib[5].

Tramadol Hydrochloride

• Regulatory Scrutiny: Stringent regulatory frameworks, particularly in the United States, closely monitor Tramadol due to its potential for abuse and dependence, which can impact market growth[4].
• Competition from Alternatives: The availability of other pain management drugs and non-opioid alternatives can reduce the preference for Tramadol[2].

Distribution Channels

Celecoxib

• The Celecoxib market is primarily distributed through hospital pharmacies, retail pharmacies, and online pharmacies. Each channel has unique characteristics and advantages that influence accessibility and pricing[1].

Tramadol Hydrochloride

• The Tramadol market is also segmented into hospital pharmacies, retail pharmacies, and online pharmacies. The hospital pharmacy segment accounts for a significant revenue share, while the online pharmacy segment is expected to grow at the fastest CAGR[2][4].

Geographical Analysis

Celecoxib

• North America: The United States is a major market for Celecoxib, benefiting from strong healthcare infrastructure and high prevalence of chronic pain disorders[1].
• Europe: The market is influenced by varying healthcare systems across countries, with nations like Germany, France, and the UK leading in prescription rates[1].
• Asia-Pacific: This region is witnessing significant growth due to an increasing population, rising healthcare expenditure, and expanding medical facilities, particularly in China and India[1].

Tramadol Hydrochloride

• Europe: Expected to maintain a major stake in the Tramadol market due to high healthcare expenditure and favorable government initiatives for opioid substitution therapy[2].
• Asia-Pacific: This region is anticipated to see lucrative development due to growing product consumption by patients suffering from chronic pain and other disorders, along with increasing disposable income levels in developing countries like China and India[2][4].

Key Players

Celecoxib

• Top companies operating in the Celecoxib market include Pfizer Inc., Teva, Mylan, Apotex, Lupin, and Hengrui Medicine[3].

Tramadol Hydrochloride

• Leading manufacturers in the Tramadol market include Pfizer Inc., Johnson & Johnson, Teva Pharmaceuticals, and GSK plc[4].

Innovations and Future Outlook

Celecoxib

• Innovations in drug delivery systems and the potential for combination therapies with other pain relievers can enhance market growth and patient compliance[1].
• Regulatory approvals for additional indications can further expand the market for Celecoxib[1].

Tramadol Hydrochloride

• Advancements in tablet coating technologies and the development of extended-release formulations are revolutionizing the Tramadol market, improving efficacy and patient compliance[4].
• The approval of co-formulated celecoxib and tramadol for acute pain management is an example of innovative combinations that can drive market growth[4].

Key Takeaways

• Both Celecoxib and Tramadol Hydrochloride markets are driven by the increasing prevalence of chronic pain and advancements in drug formulations.
• Regulatory approvals and expanding healthcare expenditure are crucial for market growth.
• Generic alternatives and pricing pressure are significant restraints for Celecoxib, while regulatory scrutiny and competition from alternatives affect the Tramadol market.
• Distribution channels and geographical segments play vital roles in market dynamics.

FAQs

1. What is the projected market size for Celecoxib by 2031? The Celecoxib market is projected to reach USD 2.87 billion by 2031, growing at a CAGR of 8.8% during the forecast period 2024-2031[1].

2. What drives the growth of the Tramadol Hydrochloride market? The growth of the Tramadol Hydrochloride market is driven by the increasing prevalence of chronic pain, advancements in drug formulations, and expanding regulatory approvals[2][4].

3. Which distribution channels are most significant for Celecoxib and Tramadol Hydrochloride? Both markets are primarily distributed through hospital pharmacies, retail pharmacies, and online pharmacies, with hospital pharmacies accounting for a significant revenue share[1][2].

4. How do generic alternatives impact the Celecoxib market? Generic alternatives pose a substantial restraint on Celecoxib sales, as they offer cheaper versions of the medication, leading to a decline in preference for branded Celecoxib[1].

5. What are the key geographical markets for Tramadol Hydrochloride? Europe is expected to maintain a major stake in the Tramadol market, while the Asia-Pacific region is anticipated to see lucrative development due to growing healthcare needs and increasing disposable income levels[2][4].

Sources

1. Verified Market Research - Celecoxib Market Size, Share, Trends & Forecast[1]
2. Verified Market Research - Tramadol Drug Market Size, Share, Trends, Growth And Forecast[2]
3. Business Research Insights - Celecoxib Market Size, Share, Growth, And Industry 2032[3]
4. Stellar Market Research - Tramadol Market: Global Industry Analysis and Forecast (2024-2030)[4]
5. GlobeNewswire - COX-2 Selective NSAIDs Market Research Report 2025-2030[5]