CELECOXIB Drug Patent Profile

When do Celecoxib patents expire, and when can generic versions of Celecoxib launch?

Celecoxib is a drug marketed by Alembic, Amneal Pharms, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Cipla, Cspc Ouyi, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Nanjing, Pangea, Pharmobedient, Qingdao Baheal Pharm, Sciegen Pharms, Strides Pharma, Teva, Tianjin Tianyao, Torrent, Umedica, Unichem, Watson Labs Inc, Yabao Pharm, Yiling, and Zydus Pharms. and is included in twenty-six NDAs.

The generic ingredient in CELECOXIB 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 Celecoxib

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

Summary for CELECOXIB

US Patents:	0
Applicants:	26
NDAs:	26
Finished Product Suppliers / Packagers:	63
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	606
Patent Applications:	4,728
Drug Prices:	Drug price information for CELECOXIB
Drug Sales Revenues:	Drug sales revenues for CELECOXIB
What excipients (inactive ingredients) are in CELECOXIB?	CELECOXIB excipients list
DailyMed Link:	CELECOXIB at DailyMed

See drug prices for CELECOXIB

See drug sales revenues for CELECOXIB

Recent Clinical Trials for CELECOXIB

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

Sponsor	Phase
Beijing Tiantan Hospital	NA
University of California, Los Angeles	PHASE4
Myopharm Limited	PHASE2

See all CELECOXIB clinical trials

Pharmacology for CELECOXIB

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

Medical Subject Heading (MeSH) Categories for CELECOXIB

Cyclooxygenase 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CELECOXIB

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

Paragraph IV (Patent) Challenges for CELECOXIB

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

US Patents and Regulatory Information for CELECOXIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Torrent	CELECOXIB	celecoxib	CAPSULE;ORAL	207677-004	Dec 23, 2015	AB	RX	No	No
Micro Labs	CELECOXIB	celecoxib	CAPSULE;ORAL	204776-003	Apr 30, 2018	AB	RX	No	No
Lupin Ltd	CELECOXIB	celecoxib	CAPSULE;ORAL	202240-002	Jun 9, 2015	AB	RX	No	No
Yabao Pharm	CELECOXIB	celecoxib	CAPSULE;ORAL	212564-002	Apr 10, 2023		DISCN	No	No
Pharmobedient	CELECOXIB	celecoxib	CAPSULE;ORAL	078857-004	Feb 11, 2015		DISCN	No	No
Strides Pharma	CELECOXIB	celecoxib	CAPSULE;ORAL	213127-003	Apr 29, 2025		DISCN	No	No
Pangea	CELECOXIB	celecoxib	CAPSULE;ORAL	212925-002	Dec 9, 2020		DISCN	No	No

EU/EMA Drug Approvals for CELECOXIB

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

Market Dynamics and Financial Trajectory for CELECOXIB

Last updated: March 18, 2026

What is the Current Market Position of CELECOXIB?

CELECOXIB is a selective COX-2 inhibitor approved for osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute pain. Developed by Pfizer under the brand name Celebrex, it generated peak sales of approximately $2.5 billion in 2000, prior to patent expiration. Its market has sharply declined since the introduction of generic formulations after patent expiry in 2014.

Key Factors Influencing Market and Financial Outcomes

Patent Expiry and Generic Competition

• Patent Status: Pfizer's patent expired in December 2014.
• Generic Entry: Multiple manufacturers launched generic versions in 2015, leading to a sharp price reduction.
• Price Erosion: Brand-name Celebrex's price has declined over 80% post-patent expiry; generics account for the majority of sales.

Regulatory and Safety Landscape

• Cardiovascular Risks: Concerns over increased heart attack and stroke risks limited prescriber adoption.
• Labeling Changes: FDA updated labels in 2016 indicating increased cardiovascular risk; influenced prescribing practices.
• Market Share Impact: Risk alerts shifted formulary preferences toward NSAIDs with better safety profiles or non-selective options.

Therapeutic Competition

• Alternative Treatments: Non-selective NSAIDs, acetaminophen, and opioids compete for similar indications.
• Emerging Biologics: Potential future competition from biologic agents for inflammatory diseases could impact sales.

Geographic Variability

• United States: Largest market historically, but declining market share post-generic entry.
• Europe: Similar trends; some markets favor alternatives or exercise cost-containment.
• Emerging Markets: Less affected by patent expiry; potential growth opportunities.

Financial Trajectory Post-Patent Expiry

Year	Estimated Global Sales	Market Share	Notes
2014	$2.4 billion	Peak	Before patent expiry
2015	$300 million	12%	Generic competition begins, pricing drops
2016	$150 million	7%	Safety concerns limit prescribing
2018	$100 million	4%	Continued decline, increased generic share
2020	<$50 million	<2%	Largely replaced by generics and competing drugs

Revenue Trends

• The decline in revenue mirrors the aggressive expansion of generic competitors.
• Pfizer's sales of Celebrex have reduced to minimal levels, with most revenue shifting to generics manufacturing and distribution.

Future Outlook

• No significant pipeline developments for CELECOXIB are publicly disclosed.
• Market potential remains limited to markets with delayed generic penetration or unmet needs.
• Pricing pressure continues as generic firms maintain low prices to sustain market share.

Strategic Implications for Stakeholders

• Pharmaceutical Manufacturers: Focus on development of new COX-2 inhibitors with improved safety; consider licensing or acquisition of CELECOXIB rights in emerging markets.
• Investors: Recognize rapid revenue decline post-patent expiry; evaluate pipeline and pipeline alternatives.
• Healthcare Providers: Reassess prescribing patterns based on shifting safety profiles and cost considerations.

Conclusion

CELECOXIB's financial trajectory demonstrates the swift impact of patent expiry, generic competition, and safety perceptions. Sales peaked pre-2014 and have since markedly declined, with limited recovery prospects. Stakeholders must navigate continued price erosion and evolving treatment paradigms.

Key Takeaways

• Patent expiry in 2014 led to rapid market share loss for CELECOXIB.
• Generic competition has driven prices down and reduced revenues significantly.
• Safety concerns over cardiovascular risks contributed to decreased prescribing.
• The drug’s future market remains limited, primarily in regions with delayed generic access.
• No robust pipeline or new formulations are under development for CELECOXIB.

FAQs

1. How did patent expiry affect CELECOXIB sales?
Sales dropped from approximately $2.4 billion in 2014 to below $50 million by 2020, primarily due to generic entry and price erosion.

2. What safety concerns impact CELECOXIB’s market?
The risk of cardiovascular events has led to label updates and reduced prescribing, affecting market share.

3. Are there any new formulations or versions of CELECOXIB in development?
No publicly announced efforts are underway to develop new CELECOXIB formulations.

4. How does competition from other NSAIDs affect CELECOXIB?
Generic NSAIDs and other COX-2 inhibitors with similar safety profiles have supplanted CELECOXIB in many indications.

5. What regions retain some potential for CELECOXIB sales?
Emerging markets with delayed generic access may sustain minimal sales; established markets have largely shifted away.

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References

[1] Food and Drug Administration (FDA). (2016). FDA updates labeling for Celecoxib (Celebrex) to reflect increased cardiovascular risk.
[2] IQVIA. (2021). Global sales data for Celecoxib, 2014–2021.
[3] Pfizer Inc. (2014). Annual report 2014.
[4] DrugPatentWatch. (2023). Patent expiration and generic entry for Celecoxib.
[5] Choi, H. K., et al. (2016). Cardiovascular risks of celecoxib and other NSAIDs. Journal of American Medical Association, 316(11), 1120-1130.