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-five 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:	4
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
Translational Genomics Research Institute	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
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-002	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
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-003	Aug 29, 2002
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-001	Dec 31, 1998
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-003	Aug 29, 2002
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-002	Dec 31, 1998
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-004	Dec 15, 2006
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-001	Dec 31, 1998

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
Spain	2141916
World Intellectual Property Organization (WIPO)	9515316
Australia	690609
China	1699347
Finland	115053
Austria	212985
Taiwan	467900

Supplementary Protection Certificates for CELEBREX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0731795	4/2009	Austria		PRODUCT NAME: MAVACOXIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/2/08/084/001-005 20080909
0731795	91538	Luxembourg		91538, EXPIRES: 20191114
0731795	2009C/009	Belgium		PRODUCT NAME: MAVACOXIB; REGISTRATION NO/DATE: EU/0/08/084/001 20080911
0731795	300380	Netherlands		ZOETIS SERVICES LLC
0731795	10075033	Germany		PRODUCT NAME: CELECOXIB; NAT. REGISTRATION NO/DATE: 48802.00.00 20000518; FIRST REGISTRATION: SE 14838 19991203
0731795	122009000012	Germany		PRODUCT NAME: MAVACOXIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/2/08/084/001-005 20080909
0731795	CA 2009 00005	Denmark		PRODUCT NAME: MAVACOXIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF

Market Dynamics and Financial Trajectory for CELEBREX

Last updated: November 17, 2025

Introduction

CELEBREX (celecoxib) is a selective COX-2 inhibitor developed by Pfizer, approved in 1998 for the treatment of osteoarthritis, rheumatoid arthritis, acute pain, and menstrual pain. As a prominent selective non-steroidal anti-inflammatory drug (NSAID), CELEBREX has experienced a complex market trajectory influenced by safety concerns, competitor evolution, regulatory scrutiny, and shifting therapeutic paradigms. This analysis provides an in-depth review of the current market dynamics and financial trajectory of CELEBREX, examining key drivers, challenges, and forecasted trends shaping its commercial landscape.

Market Overview

Historical Market Position

CELEBREX emerged as a major player in the NSAID market, initially capturing significant market share due to its favorable gastrointestinal safety profile compared to traditional NSAIDs. Its unique mechanism—selective inhibition of COX-2—aimed to mitigate gastrointestinal (GI) side effects, a common adverse event with older NSAIDs.

However, around 2004, post-market surveillance and data from the celecoxib lawsuit period drew attention to potential cardiovascular risks associated with its use. Despite this, CELEBREX maintained substantial revenue streams, largely due to its differentiated profile and established clinical efficacy.

Current Market Share and Revenue

In the United States, CELEBREX competes primarily with generic NSAIDs, COX-2 inhibitors like celecoxib's generics, and alternative pain management drugs. Pfizer’s patent exclusivity for CELEBREX expired in 2014, leading to a surge in generic availability, sharply reducing the drug’s price point and profit margins.

Pfizer reported revenues for CELEBREX approximating $500 million globally in recent years, a decline from peak sales exceeding $1 billion in the early 2000s. The primary revenue is now derived from the U.S. and certain European markets, but overall, sales are constrained by generic competition, safety concerns, and clinical adoption shifts.

Market Dynamics Influencing CELEBREX

Competitive Landscape

Generic Competition: Since patent expiration, the entry of multiple generic celecoxib formulations has undercut CELEBREX’s pricing power. Generics typically account for over 90% of NSAID prescriptions in major markets, pressure that Pfizer’s branded stiffs have struggled to resist fully.

Alternative Therapeutics: The advent of biologic therapies for inflammatory and autoimmune conditions has diverted some focus away from NSAIDs altogether. Non-pharmacologic treatments and newer NSAIDs with better safety profiles further limit CELEBREX’s market share.

Emerging Pain Management Paradigms: Emphasis on opioid-sparing strategies and comprehensive pain management protocols have indirectly decreased reliance on NSAIDs, especially in chronic settings.

Safety and Regulatory Considerations

Cardiovascular Risks: The 2004 withdrawal of rofecoxib (Vioxx) heightened awareness around COX-2 inhibitors’ cardiovascular dangers. While CELEBREX was not withdrawn, subsequent studies revealed increased risks of myocardial infarction and stroke, influencing prescribing behaviors (Borer et al., 2006). Regulatory agencies have issued warnings and monitored post-marketing data, impacting physician confidence.

Gastrointestinal Safety: Despite its GI safety advantage, concerns persist due to the cardiovascular risks, especially in high-risk populations, leading to cautious prescribing patterns.

Patents and Legal Challenges

Pfizer faced multiple lawsuits related to cardiovascular risks and marketing practices. Although the direct impact on sales is limited, legal and reputation risks dampen long-term growth prospects.

Market Trends

Shift Toward Biologics and Non-NSAID Options: The expansion of biologics for autoimmune diseases and non-opioid analgesics diminishes the reliance on traditional NSAIDs, including CELEBREX.

Geophysical Expansion: Emerging markets in Asia and Latin America offer growth opportunities, contingent on regulatory approvals and affordability factors.

Financial Trajectory and Forecasts

Revenue Trends

Post-patent expiry, CELEBREX’s revenues have contracted significantly. Pfizer anticipates ongoing declines driven by intensified generic competition and shifting physician preferences. Estimations suggest a compound annual decline rate (CAGR) of approximately 10–15% over the next five years.

Profitability Outlook

While generic competition compresses sales revenue, Pfizer’s economies of scale and manufacturing efficiencies sustain profitability levels at low single digits for CELEBREX. The drug’s legacy brands function as cash generators for Pfizer’s broader pipeline portfolio.

Future Market Projections

Short-Term (Next 2–3 Years): Expect sales stabilization owing to limited pipeline alternatives and existing loyal prescriber base, with revenues likely to plateau or decline marginally.

Medium to Long-Term (3–10 Years): Revenue decline is projected to accelerate absent innovative formulations or new indications. Pfizer may consider lifecycle management strategies like reformulations, combination therapies, or NLME (new molecular entity) development related to celecoxib derivatives.

Impact of Potential Regulatory Actions

Any new safety warnings or labeling restrictions could precipitate further sales reductions. Conversely, new indications demonstrating improved safety or efficacy profiles could provide incremental revenue streams.

Key Market Drivers and Barriers

Drivers	Barriers
Established efficacy in pain and inflammation	Safety concerns hindering adoption in high-risk groups
Patent expiry and generic proliferation leading to broader accessibility	Decline in physician prescribing due to cardiovascular risks
Growth in emerging markets	Variations in regulatory environments and market penetration challenges
Adoption of multimodal pain management	Competition from biologics and alternative therapies

Concluding Remarks

CELEBREX’s market trajectory exemplifies the challenges faced by legacy drugs in a competitive, scrutinized landscape. Its future hinges on balancing safety considerations, market positioning, and therapeutic innovation. While ongoing revenue streams persist, the drug’s growth prospects are constrained unless Pfizer innovates through line extensions, new uses, or combination therapies.

Key Takeaways

• Patent expiry and generic entry have dramatically compressed CELEBREX’s revenue, reducing its role from a top-tier NSAID to a niche medication.
• Cardiovascular safety concerns significantly influence prescribing patterns, prompting cautious deployment in high-risk patients.
• Market shift toward biologics and alternative pain therapies limits CELEBREX’s growth potential.
• Emerging markets could offer incremental opportunities, contingent on regulatory approval and price sensitivity.
• Lifecycle management strategies may be essential for maintaining profitability; without innovation, CELEBREX’s financial trajectory will continue downward.

FAQs

1. What are the main safety concerns associated with CELEBREX?
   Cardiovascular risks—including increased incidence of myocardial infarction and stroke—are the primary safety issues that have impacted prescribing and regulatory scrutiny.

2. How has patent expiration affected CELEBREX’s market share?
   Post-patent expiry in 2014, the entry of multiple generics led to a sharp decline in sales, as pricing competition eroded Pfizer’s revenue streams.

3. Are there any new indications or formulations for CELEBREX?
   Currently, no significant new indications or formulations are in advanced stages. Lifecycle management options are limited, emphasizing the importance of exploring combinatorial approaches or new patent protections.

4. What is the outlook for CELEBREX in emerging markets?
   These markets may provide incremental growth owing to unmet medical needs and less stringent regulatory environments, provided affordability and awareness are addressed.

5. Can CELEBREX sustain profitability amid declining sales?
   Given its low manufacturing costs and established market presence, CELEBREX can still generate profit, though margins will likely diminish unless new revenue opportunities emerge.

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References

[1] Borer, B. et al. (2006). Cardiovascular Risks of COX-2 Inhibitors. The New England Journal of Medicine.
[2] Pfizer Inc. Financial Reports (latest).
[3] Market research reports on NSAID global market trends.