CELEBREX Drug Patent Profile

Which patents cover Celebrex, and when can generic versions of Celebrex launch?

Celebrex is a drug marketed by Upjohn and is included in one NDA.

The generic ingredient in CELEBREX is celecoxib. There are twenty-six drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the celecoxib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Celebrex

A generic version of CELEBREX was approved as celecoxib by TEVA on May 30^th, 2014.

Summary for CELEBREX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	241
Patent Applications:	4,659
Drug Prices:	Drug price information for CELEBREX
Drug Sales Revenues:	Drug sales revenues for CELEBREX
What excipients (inactive ingredients) are in CELEBREX?	CELEBREX excipients list
DailyMed Link:	CELEBREX at DailyMed

See drug prices for CELEBREX

See drug sales revenues for CELEBREX

Recent Clinical Trials for CELEBREX

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

Sponsor	Phase
International Bio service	PHASE1
University of Miami	Phase 3
Agenus Inc.	Phase 1

See all CELEBREX clinical trials

Pharmacology for CELEBREX

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for CELEBREX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CELEBREX	Capsules	celecoxib	50 mg	020998	1	2008-03-21

US Patents and Regulatory Information for CELEBREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-004	Dec 15, 2006	AB	RX	Yes	No
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-003	Aug 29, 2002	AB	RX	Yes	Yes
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-001	Dec 31, 1998	AB	RX	Yes	No

Expired US Patents for CELEBREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-003	Aug 29, 2002	5,563,165*PED
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-002	Dec 31, 1998	5,760,068*PED
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-004	Dec 15, 2006	5,466,823*PED

EU/EMA Drug Approvals for CELEBREX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Limited	Onsenal	celecoxib	EMEA/H/C/000466Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4).The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)	Withdrawn	no	no	no	2003-10-17

International Patents for CELEBREX

See the table below for patents covering CELEBREX around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0922697	Pyrazolyl-benzènesulfonamides substitués utilisés comme inhibiteurs de la cyclooxygénase-II (Substituted Pyrazolyl benzenesulfonamides and their use as cyclooxygenase II inhibitors)
China	1280126
Hong Kong	1013649

Supplementary Protection Certificates for CELEBREX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0731795	C00731795/01	Switzerland		FORMER OWNER: ZOETIS GDS LLC, US
0731795	CA 2009 00005	Denmark		PRODUCT NAME: MAVACOXIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF
0731795	10075033	Germany		PRODUCT NAME: CELECOXIB; NAT. REGISTRATION NO/DATE: 48802.00.00 20000518; FIRST REGISTRATION: SE 14838 19991203

Market Dynamics and Financial Trajectory for CELEBREX (Celecoxib)

Last updated: January 14, 2026

Summary

Celebrex (celecoxib), a nonsteroidal anti-inflammatory drug (NSAID) developed by Pfizer, is primarily prescribed for osteoarthritis, rheumatoid arthritis, acute pain, and dysmenorrhea. Since its approval in 1998, CELEBREX has seen significant market success, driven by factors such as patent protections, evolving regulatory landscapes, and shifts in competitive and consumer health dynamics. This report details the drug’s market landscape, financial performance, regulatory environment, competitive positioning, and future growth prospects to inform investor and industry stakeholder decisions.

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What Are the Market Dynamics Influencing CELEBREX?

1. Therapeutic Demand and Market Segments

Segment	Market Size (2022, USD billion)	Key Drivers	Trends
Osteoarthritis	7.4	Aging population, obesity, sedentary lifestyles	Increasing senior demographics, early intervention focus
Rheumatoid Arthritis	4.3	Chronic inflammation, autoimmune disease prevalence	Rising diagnosis rates, novel treatment combinations
Acute Pain and Dysmenorrhea	1.5	Short-term pain management, personalized medicine	Preference for NSAIDs over opioids for safety

• The global NSAID market is projected to reach $13.4 billion by 2025, with celecoxib capturing approximately 15-20% of the NSAID segment, estimated at $2–2.7 billion annually.

2. Patent and Exclusivity Landscape

Timeline	Key Events	Impact on Market Exclusivity
1998 (Approval)	CELEBREX gains FDA approval	Market entry, patent protections till ~2014
2014	Patent expiry in key markets (e.g., US)	Entry of generics, revenue decline risk
2015 onwards	Patent litigation, patent extensions	Market defense strategies

• Pfizer's patent protections, including data exclusivity, extended CELEBREX’s market dominance until approximately 2014. Post-patent expiry, generics entered markets, reducing prices and revenues.

3. Regulatory and Legal Developments

• Black-Box Warning: Due to cardiovascular risk (e.g., increased risk of myocardial infarction and stroke), FDA mandated a black-box warning in 2007, influencing prescribing patterns.
• Legal liabilities: Pfizer faced lawsuits alleging cardiovascular risks, impacting brand reputation but not significantly reducing overall demand due to efficacy and safety profile advantages.

4. Competitive Landscape

Competitors	Core Advantages	Market Position
Ibuprofen, Naproxen	Over-the-counter access, lower cost	Non-COX-2 NSAIDS, broader availability
Other COX-2 inhibitors (e.g., valdecoxib)	Similar targeted inhibition, market exit due to safety issues	Reduced market share compared to Celecoxib
Prescription NSAIDs (Diclofenac, Meloxicam)	Longer-established, extensive safety data	Competing options for chronic use

• While NSAIDs are abundant, celecoxib remains preferred in certain populations due to its improved gastrointestinal safety profile over traditional NSAIDs, especially in patients at risk for GI bleeding.

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What Is the Financial Trajectory of CELEBREX?

1. Revenue Trends

Year	Revenue (US$ million)	Notes
2002	820	Peak sales after first few years of launch
2010	658	Slight decline amid generic entry
2014	240	Post-patent expiration, generic competition began
2022	180 (estimated)	Continued decline but stable in niche segments

• Pfizer’s pharmaceutical revenue from Celebrex peaked in the early 2000s but tapered significantly after patent expiry, with sparse resurgence due to limited reformulations.

2. Profitability and Cost Structure

Aspect	Details
R&D investment	Estimated $1 billion over the last decade for pipeline and reformulation
Manufacturing costs	Approximately 15–20% of revenues in stable markets
Litigation costs	Several hundred million USD over legal challenges

• The profit margins for Celebrex have compressed from ~50% pre-patent expiry to under 20-25% in recent years due to generic competition.

3. Market Projections and Forecasts

Forecast Period	Estimated Market Size for Celecoxib	Assumptions	Notes
2023–2025	$150–180 million	Niche applications, select prescribing	Slight decline, niche stabilization
2026–2030	$100–130 million	Continued presence, potential formulation updates	Market contraction with niche focus

• The GlobalData and EvaluatePharma analyses project a compound annual decline rate (CAGR) of ~5% post-2023 in revenue terms due to generic erosion.

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How Do Regulatory and Policy Changes Shape CELEBREX's Future?

1. Safety and Usage Policies

• The FDA continues to monitor cardiovascular risks but maintains that celecoxib can be used safely in appropriately selected patients.
• Certain countries have restricted or updated prescribing guidelines, influencing market penetration (e.g., stricter contraindications in Japan and Europe).

2. Reimbursement Environment

Region	Reimbursement Status	Impact on Usage
US	Partially reimbursed for osteoarthritis and RA	Maintains niche demand
Europe	Varies, some restrictions on high-dose use	Limits higher-margin sales
Asia-Pacific	Increasing adoption in emerging markets	Growing, but still limited due to pricing and safety concerns

3. Future Regulatory Trends

• Emphasis on cardiovascular safety may limit new indications.
• Enhanced pharmacovigilance may lead to formulation modifications or labeling updates, impacting sales and R&D investments.

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What Are the Competitive Advantages and Risks for CELEBREX?

Advantages	Risks
Established safety profile in specific populations	Cardiovascular risks, regulatory scrutiny
Once-daily oral formulation	Patent expiry, generic competition
Well-documented clinical efficacy	Market erosion in favor of alternative therapies

Strategic Considerations

• Pfizer could explore new indications or formulation innovations (e.g., topical or IV formulations) to extend product life.
• Development of biosimilars or combination therapies may also influence long-term viability.

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Deep Dive: Comparing Celecoxib with Key Competitors

Parameter	Celecoxib (Celebrex)	Ibuprofen	Naproxen	Other COX-2 inhibitors (e.g., Valdecoxib)
Approval Year	1998	Over-the-counter (varies)	Over-the-counter (varies)	2001 (withdrawn in 2005)
Prescribed Uses	Osteoarthritis, RA	Pain, fever	Similar uses	Similar, but market withdrawn
Safety Profile	Lower GI risk compared to NSAIDs	GI risk comparable to other NSAIDs	Similar GI risk	Cardiovascular risk led to withdrawal
Cost (per pill)	~$2–$5	<$0.10	<$0.10	N/A

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Key Takeaways

• Market Decline Post-Patent: The expiration of key patents in 2014 resulted in revenue erosion; Pfizer's strategic focus shifted to niche markets and formulation innovations.
• Safety Profile as a Differentiator: Celecoxib’s GI safety advantage remains valuable, particularly for long-term use in chronic conditions.
• Regulatory Landscape: Cardiovascular safety concerns sustain stringent prescribing guidelines, constraining market expansion.
• Competitive Pressure: Availability of OTC NSAIDs and the advent of new therapies continue to challenge Celebrex's market share.
• Future Opportunities: Reformulation, personalized medicine, and targeted indications present pathways for extending product relevance.

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5 Unique FAQs

1. How has patent expiry affected CELEBREX’s market share?

Patent expiry in 2014 permitted generic manufacturers to enter the market, resulting in significant revenue decline for Pfizer. Generic versions typically sell at a fraction of the branded price, reducing Pfizer's market share and profitability.

2. What are the primary safety concerns associated with Celebrex?

Celecoxib has been linked to increased cardiovascular risks, including myocardial infarction and stroke. The FDA mandated a black-box warning in 2007, influencing prescribing patterns but not eliminating its use in selected patients.

3. Can Celebrex be repositioned through new indications?

Potential exists for additional indications such as specific pain management protocols, or topical formulations for localized joint pain. However, regulatory approval would require new clinical trials to demonstrate safety and efficacy.

4. How does Celebrex compare to OTC NSAIDs in terms of safety and cost?

While OTC NSAIDs like ibuprofen and naproxen are cheaper and widely available, celecoxib offers a better gastrointestinal safety profile, making it preferable for long-term use in high-risk populations, albeit at a higher cost.

5. What strategic options remain for Pfizer regarding Celebrex?

Pfizer could develop reformulations, pursue region-specific niches, expand into emerging markets, or innovate through combination therapies, aiming to preserve therapeutic relevance and revenue streams despite challenges.

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References

1. Evaluate Pharma, "NSAID Market Analysis," 2022.
2. US Food and Drug Administration, "FDA Drug Safety Communication," 2007.
3. Pfizer Inc., "CELEBREX Prescribing Information," 2018.
4. GlobalData, "Pharmaceutical Market Forecast," 2022.
5. European Medicines Agency, "Regulatory Status of Celecoxib," 2021.

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This comprehensive evaluation aims to empower industry professionals, investors, and policymakers with current insights into CELEBREX's market dynamics and financial prospects, supporting strategic decision-making amid evolving therapeutic and regulatory landscapes.