CELECOXIB - Generic Drug Details

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

Celecoxib is the generic ingredient in five branded drugs marketed by Upjohn, 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, Zydus Pharms, Scilex Pharms, Carwin Pharm Assoc, and Kowa Pharms, and is included in thirty NDAs. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Celecoxib has twenty-six patent family members in twelve countries.

There are twenty-six drug master file entries for celecoxib. Sixty-six suppliers are listed for this compound.

Summary for CELECOXIB

International Patents:	26
US Patents:	13
Tradenames:	5
Applicants:	30
NDAs:	30
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	66
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	606
Patent Applications:	7,993
Drug Prices:	Drug price trends 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
Micro Labs	CELECOXIB	celecoxib	CAPSULE;ORAL	204776-003	Apr 30, 2018	AB	RX	No	No
Cadila Pharms Ltd	CELECOXIB	celecoxib	CAPSULE;ORAL	208701-002	Nov 14, 2019	AB	RX	No	No
Scilex Pharms	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		RX	Yes	Yes	10,799,517		Y
Sciegen Pharms	CELECOXIB	celecoxib	CAPSULE;ORAL	205129-001	Dec 3, 2020	AB	RX	No	No
Zydus Pharms	CELECOXIB	celecoxib	CAPSULE;ORAL	205938-002	Jul 14, 2025		DISCN	No	No
Scilex Pharms	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		RX	Yes	Yes	9,572,819		Y
Pangea	CELECOXIB	celecoxib	CAPSULE;ORAL	212925-001	Dec 9, 2020		DISCN	No	No

Expired US Patents for CELECOXIB

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
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-002	Dec 31, 1998	5,466,823*PED
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-002	Dec 31, 1998	5,972,986*PED
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-003	Aug 29, 2002	5,760,068*PED
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-001	Dec 31, 1998	5,563,165*PED

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

International Patents for CELECOXIB

Country	Patent Number	Title	Estimated Expiration
Brazil	112018074486
Russian Federation	2708254	Пероральная композиция целекоксиба для лечения боли (ORAL CELECOXIB COMPOSITION FOR TREATING PAIN)
European Patent Office	3302429
Australia	2016267685
Russian Federation	2018146386
Mexico	2017015238	COMPOSICION ORAL DE CELECOXIB PARA TRATAMIENTO DE DOLOR. (ORAL COMPOSITION OF CELECOXIB FOR TREATMENT OF PAIN.)
Russian Federation	2745196

Supplementary Protection Certificates for CELECOXIB

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
2488169	C202330042	Spain		PRODUCT NAME: COCRISTAL DE TRAMADOL, OPCIONALMENTE EN FORMA DE UNA SAL FISIOLOGICAMENTE ACEPTABLE, Y CELECOXIB; NATIONAL AUTHORISATION NUMBER: 89051; DATE OF AUTHORISATION: 20230925; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 89051; DATE OF FIRST AUTHORISATION IN EEA: 20230925

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.