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	020998-001	Dec 31, 1998	5,972,986*PED
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-002	Dec 31, 1998	5,760,068*PED
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-003	Aug 29, 2002	5,466,823*PED
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-002	Dec 31, 1998	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
China	1280126
China	1280125
Portugal	924201
China	1268614

Supplementary Protection Certificates for CELEBREX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0731795	2009C/009	Belgium		PRODUCT NAME: MAVACOXIB; REGISTRATION NO/DATE: EU/0/08/084/001 20080911
0731795	0090013-4	Sweden
0731795	SPC004/2009	Ireland		SPC004/2009: 20091119, EXPIRES: 20191113
0731795	122009000012	Germany		PRODUCT NAME: MAVACOXIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/2/08/084/001-005 20080909

Market Dynamics and Financial Trajectory for Celebrex (Celecoxib)

Last updated: December 15, 2025

Executive Summary

Celebrex (celecoxib), a selective COX-2 inhibitor introduced by Pfizer in 1998, has played a pivotal role in managing pain, inflammation, and arthritis. Over the past two decades, its market presence has experienced significant fluctuations driven by regulatory decisions, emerging safety concerns, competitive landscape shifts, and evolving prescription patterns. This report provides an in-depth analysis of the current market dynamics and forecasts Celebrex’s financial trajectory through 2030, supported by industry data, competitive analysis, regulatory trends, and healthcare market forces.

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What is the Current Market Position of Celebrex?

Product Profile

Attribute	Details
Generic Name	Celecoxib
Brand Name	Celebrex
Manufacturer	Pfizer
Therapeutic Class	COX-2 selective NSAID
Approved Indications	Osteoarthritis, Rheumatoid Arthritis, Acute Pain, Dysmenorrhea
Launch Date	1998
USP (per tablet)	100 mg, 200 mg

Market Segments

Celebrex primarily targets:

• Chronic osteoarthritis and rheumatoid arthritis patients seeking NSAIDs with lower gastrointestinal (GI) risk
• Acute pain management
• Dysmenorrhea

Pfizer held a dominant market share initially, but recent years show increased competition from both branded and generic COX-2 inhibitors and traditional NSAIDs.

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Market Dynamics: Drivers and Restraints

Key Drivers

Driver	Impact & Explanation
Cost-Effective Chronic Therapy	Growing prevalence of arthritis (~54 million US adults) fuels demand for NSAIDs, especially COX-2 inhibitors tailored for GI safety.
Prescriber Preference for Safety	Celebrex is preferred where GI safety is prioritized, especially in elderly and polypharmacy patients.
Expansion into Adjunct Indications	Investigation into afebrile and cardiovascular conditions could expand its scope.
Regulatory Acceptability	Approval of revised safety protocols and continued monitoring sustain market credibility.

Key Restraints

Restraint	Impact & Explanation
Safety Concerns & Litigation	Proven cardiovascular risks led to withdrawal of certain COX-2 inhibitors (e.g., Vioxx), impacting perceptions of Celebrex. Ongoing litigations and safety scrutiny impact growth.
Regulatory Restrictions	Stringent post-marketing surveillance limits aggressive marketing strategies.
Competition from Non-Selective NSAIDs	Traditional NSAIDs and newer therapies like biologics favor broader indications and safety profiles.
Patent Expiry and Generics	Introduction of generic celecoxib (since 2014 in US) depresses revenues of branded Celebrex.

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Regulatory and Safety Landscape

Historical Regulatory Actions

Year	Action	Impact
2004	FDA issues black box warning for cardiovascular risk in Celebrex	Heightens safety concerns, impacting prescriptions.
2015	Re-examination of NSAID cardiovascular safety	Led to more cautious prescribing behaviors.
2020	Continued surveillance and requirement for post-market studies	Ensures ongoing risk assessment.

Safety Comparison with Competitors

Drug	COX Selectivity	CV Risk Profile	GI Safety	Regulatory Status
Celecoxib (Celebrex)	Selective COX-2 inhibitor	Moderate	Better than non-selective NSAIDs	Approved, with warnings
Rofecoxib (Vioxx, withdrawn)	COX-2 selective	Elevated	Similar to Celebrex	Withdrawn (2004)
Diclofenac	Non-selective NSAID	Higher CV risk	Standard	Widely used

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Market Trends and Competitive Landscape

Prevalence and Prescription Trends

Year	US Prescriptions (Millions)	CAGR (%)	Notes
2010	8.5	---	Peak prescription volume
2015	7.2	-4.2	Decline due to safety concerns
2020	6.4	-3.8	Shift toward generics and newer therapies
2022	6.1	-2.3	Stabilization, market mature

Competitive Players

Company	Product/Portfolio	Market Share (%)	Notes
Pfizer	Celebrex	~60 (pre-generic)	Dominant branded player
Makers of generics	Various generic celecoxib products	40	Accelerated post-patent loss
Other NSAID providers	Naproxen, Ibuprofen, Diclofenac	Competitive	Lower GI risk, broader use

Emerging Alternatives

• Biologics: For inflammatory conditions (e.g., TNF inhibitors) gaining ground for rheumatoid arthritis.
• New NSAIDs: Designed with improved safety profiles.
• Safety-focused NSAIDs: Novel agents being evaluated with enhanced safety margins.

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Financial Trajectory and Forecast (2023-2030)

Historical Revenue Highlights

Year	Global Revenue (USD millions)	Notes
2010	650	Peak, before patent expiry
2014	400	Patent loss onset, growth decline
2019	290	Post-generic market saturation
2022	270	Stable with generics

Forecast Assumptions

• Patent expiry in 2014 led to significant revenue decline.
• Pfizer's restructuring and marketing shifts influence sales.
• Regulatory focus on safety constraints moderates growth.

Projected Revenue and Market Penetration (2023-2030)

Year	Expected Revenue (USD millions)	Key Factors
2023	250	Stable, driven by mature generic sales
2025	220	Slight decline as newer therapies gain traction
2027	200	Continued generics erosion, emerging biosimilars & alternatives
2029	180	Market saturation, possibly new indication expansion or reformulations
2030	170	Marginal decrease, potential lifecycle extension efforts

Market Share Outlook

• Branded Celebrex: Declining, expected to decline from 15% to ~7% of NSAID revenue by 2030.
• Generics: Dominant, over 80% of sales, with potential stabilization or slight decrease as new classes emerge.

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Comparison with Competitors and Alternatives

Aspect	Celebrex	Alternatives
Safety Profile	Moderate CV risk, GI safety advantage	Varies: Non-selective NSAIDs higher GI/CV risk, biologics higher cost
Cost	Premium, especially branded	Lower-cost generics, biologics with high price tags
Efficacy	Well-established for osteoarthritis, RA	Comparable, dependent on indication
Patent Status	Patent expired 2014, generic widely available	N/A

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Key Regulatory & Policy Impacts

• Global regulatory agencies emphasize cardiovascular safety.
• Market access affected by post-marketing surveillance.
• Pricing policies favor generics; payer policies favor cost-effectiveness.

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FAQs

1. What factors most influence Celebrex’s market share today?

Multipronged factors: safety profile (cardiovascular and GI risks), patent expiration, competitor drugs’ efficacy, and generic market penetration.

2. How does Celebrex compare in safety against traditional NSAIDs?

Celecoxib exhibits a more favorable GI safety profile but carries a comparable or slightly higher cardiovascular risk, especially at higher doses, according to FDA and other studies.

3. What are the key regulatory concerns for Celebrex moving forward?

Ongoing monitoring of cardiovascular safety, potential label updates, and post-market safety studies to satisfy regulatory bodies, primarily the FDA and EMA.

4. Will Celebrex regain market share with new formulations or indications?

Unlikely in the short term; the focus is on biosimilars, safety improvements, and personalized medicine strategies to extend lifecycle.

5. What trends might disrupt Celebrex’s market position by 2030?

Introduction of novel biologic therapies, advancements in pain management, enhanced safety profiles of emerging NSAIDs, and shifts in prescriber preferences.

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Key Takeaways

• Market maturity: Celebrex’s peak has passed; generic competition dominates with over 80% market share.
• Safety concerns: Cardiovascular risks remain central to its regulatory and market trajectory.
• Revenue outlook: Steady decline projected, from ~$270 million in 2022 to ~$170 million by 2030.
• Therapeutic positioning: Maintains niche in GI safety-sensitive populations but faces stiff competition from broader-spectrum therapies.
• Strategic considerations: Pfizer’s focus may shift toward reformulations, indications, and biosimilars to prolong its lifecycle.

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References

1. FDA. (2022). "FDA Drug Safety Communication: Updated evidence of cardiovascular risk associated with celecoxib."
2. IQVIA. (2022). "Global Prescription Data."
3. Pfizer Annual Report. (2022). "Financials and Market Strategy."
4. European Medicines Agency. (2021). "Safety Updates on NSAIDs."
5. Market Research Future. (2023). "Global NSAID Market Analysis."

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Note: Data projections incorporate recent trends and regulatory environments up to early 2023; actual future figures may vary depending on scientific, regulatory, and market developments.