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 four branded drugs marketed by Upjohn, Acic Pharms, Alembic, Amneal Pharms, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Cipla, Cspc Ouyi, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Nanjing, Norvium Bioscience, Qingdao Baheal Pharm, Sciegen Pharms Inc, Teva, Tianjin Tianyao, Torrent, Umedica, Unichem, Watson Labs Inc, Yabao Pharm, Yiling, Scilex Pharms, and Kowa Pharms, and is included in twenty-seven 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-five patent family members in twelve countries.

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

Summary for CELECOXIB

International Patents:	25
US Patents:	13
Tradenames:	4
Applicants:	27
NDAs:	27
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	64
Raw Ingredient (Bulk) Api Vendors:	175
Clinical Trials:	563
Patent Applications:	7,481
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
HonorHealth Research Institute	Phase 1
Agenus Inc.	Phase 1
University of Arizona	Phase 1

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
Apotex	CELECOXIB	celecoxib	CAPSULE;ORAL	204197-001	Jun 2, 2015	AB	RX	No	No
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No			Y
Yiling	CELECOXIB	celecoxib	CAPSULE;ORAL	211412-003	Mar 6, 2020	AB	RX	No	No
Torrent	CELECOXIB	celecoxib	CAPSULE;ORAL	207677-002	Dec 23, 2015	AB	RX	No	No
Teva	CELECOXIB	celecoxib	CAPSULE;ORAL	076898-004	May 30, 2014	AB	RX	No	No
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No
Tianjin Tianyao	CELECOXIB	celecoxib	CAPSULE;ORAL	207872-004	Feb 25, 2020	AB	RX	No	No

Expired US Patents for CELECOXIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-002	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	020998-001	Dec 31, 1998
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-001	Dec 31, 1998
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-004	Dec 15, 2006
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-003	Aug 29, 2002

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/000466 Onsenal 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
Russian Federation	2017144574
New Zealand	737561	Oral composition of celecoxib for treatment of pain
Canada	2987272	COMPOSITION ORALE DE CELECOXIB POUR LE TRAITEMENT DE LA DOULEUR (ORAL COMPOSITION OF CELECOXIB FOR TREATMENT OF PAIN)
Brazil	112018074486	composição oral de celecoxib para tratamento da dor
Mexico	2017015238	COMPOSICION ORAL DE CELECOXIB PARA TRATAMIENTO DE DOLOR. (ORAL COMPOSITION OF CELECOXIB FOR TREATMENT OF PAIN.)
Russian Federation	2018146386	ПЕРОРАЛЬНАЯ КОМПОЗИЦИЯ ЦЕЛЕКОКСИБА ДЛЯ ЛЕЧЕНИЯ БОЛИ
World Intellectual Property Organization (WIPO)	2016191744

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

CELECOXIB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Celecoxib

Introduction to Celecoxib

Celecoxib, a nonsteroidal anti-inflammatory drug (NSAID) known for its selective inhibition of COX-2, has been a cornerstone in the management of pain and inflammation associated with various conditions, including arthritis, acute pain, and musculoskeletal pain.

Market Size and Growth Projections

The celecoxib market is anticipated to experience significant growth over the coming years. As of 2023, the market size was valued at USD 100 billion and is projected to reach USD 147.75 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[1].

In terms of the API market, the global celecoxib API market was valued at US$ 58.9 million in 2023 and is expected to reach US$ 87.0 million by 2031, with a CAGR of 5.1% during the forecast period[4].

Key Drivers of Market Growth

Rising Prevalence of Arthritis and Chronic Pain

The increasing incidence of arthritis and other chronic pain conditions globally is a major driver of the celecoxib market. As the population ages and lifestyle-related ailments become more common, the demand for effective pain management solutions like celecoxib is on the rise[1][3].

Favorable Safety Profile

Celecoxib's selective COX-2 inhibition offers a safer alternative to traditional NSAIDs, reducing gastrointestinal side effects and enhancing its adoption rate. This favorable safety profile is a significant factor in its growing market share[1][3].

Aging Population

The growing elderly population, particularly in developed regions, is driving the demand for medications like celecoxib to manage age-related inflammatory conditions. This demographic shift is expected to continue fueling market growth[1].

Introduction of Generic Versions

The availability of generic celecoxib versions has increased market accessibility, allowing broader patient access due to cost-effective options. This has expanded the commercial appeal of celecoxib, making it more affordable and accessible to a wider patient base[1][3].

Increasing Healthcare Expenditure

Global increases in healthcare spending, driven by factors such as population growth, technological advancements, and enhanced healthcare infrastructure, facilitate broader access to medications like celecoxib. Higher healthcare budgets allow for improved patient services, with insurers more likely to cover innovative pain management therapies[3].

Challenges and Restraints

Competition from Alternative Therapies

The presence of alternative pain management therapies and medications poses a challenge to the growth of the celecoxib market share. Patients and healthcare providers may opt for other treatment options, potentially reducing the demand for celecoxib[1].

Regulatory Scrutiny

Ongoing regulatory evaluations and safety concerns associated with NSAIDs may impact the market growth and prescription rates of celecoxib. Strict regulatory frameworks can affect the drug's market entry and growth[1].

Price Sensitivity

The cost of branded celecoxib and competition from generic versions can lead to price sensitivity among consumers, affecting market revenue. Healthcare cost-containment measures and increased scrutiny on drug pricing also exert pressure on manufacturers to reduce costs[1][3].

Potential Side Effects

Despite its favorable safety profile, celecoxib is not entirely free from side effects, which could limit its adoption among certain patient groups. These side effects, although less common than with traditional NSAIDs, still pose a risk and can impact market growth[1].

Market Segmentation

By Application

The celecoxib market is segmented by application into rheumatoid arthritis, osteoarthritis, acute pain, musculoskeletal pain, and others. Each segment has its own growth trajectory, with rheumatoid and osteoarthritis being significant drivers due to the high prevalence of these conditions[1][3].

By Product

The market is also segmented by product into different dosages such as 50mg, 100mg, 200mg, and 400mg celecoxib. The availability of various dosages caters to different patient needs and contributes to the market's overall growth[1].

By Geography

Geographically, the celecoxib market is segmented into North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. North America, particularly the United States, and Europe are significant markets due to strong healthcare infrastructure and high prevalence of chronic pain disorders. The Asia-Pacific region is also witnessing significant growth due to an increasing population and rising healthcare expenditure[1][3][4].

Economic Outcomes and Cost-Effectiveness

Studies have shown that celecoxib has a favorable cost-effectiveness profile compared to nonselective NSAIDs and other active-treatment options. The use of celecoxib results in lower direct medical costs, making it a more economical choice for managing chronic pain conditions[2].

Research and Development

Ongoing research is exploring new therapeutic applications for celecoxib beyond pain management, potentially expanding its market reach. Innovations in pharmaceutical technology that enhance celecoxib's formulation also contribute to the industry's worldwide market growth[1][4].

Distribution Channels and Accessibility

The rise of e-commerce platforms and online pharmacies is facilitating easier access to celecoxib, influencing market distribution channels. This increased accessibility, combined with the availability of generic versions, has broadened the market's reach and appeal[1].

Personalized Medicine Approach

The trend towards personalized medicine is leading to tailored treatment plans incorporating celecoxib based on individual patient needs and genetic factors. This approach is expected to further enhance the adoption and effectiveness of celecoxib in the market[1].

Growing Awareness and Education

Increased efforts in patient and physician education regarding the benefits and proper usage of celecoxib are contributing to its growing acceptance and demand in the market. Educational initiatives help in raising awareness about the drug's efficacy and safety, thereby driving market growth[1].

Key Takeaways

• The celecoxib market is projected to grow significantly, driven by the rising prevalence of arthritis and chronic pain, its favorable safety profile, and the aging population.
• The introduction of generic versions and increasing healthcare expenditure are key factors expanding market accessibility.
• Regulatory scrutiny, price sensitivity, and potential side effects are challenges that need to be addressed.
• Ongoing research and innovations in pharmaceutical technology are expected to expand celecoxib's therapeutic applications.
• The market is segmented by application, product, and geography, with North America and Europe being significant contributors.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of celecoxib by 2031? A: The celecoxib market is expected to reach USD 147.75 billion by 2031, growing at a CAGR of 5% from 2024 to 2031[1].

Q: What are the main drivers of the celecoxib market growth? A: The main drivers include the rising prevalence of arthritis and chronic pain, its favorable safety profile, the aging population, and the introduction of generic versions[1][3].

Q: How does celecoxib compare to traditional NSAIDs in terms of safety? A: Celecoxib offers a safer alternative to traditional NSAIDs due to its selective COX-2 inhibition, reducing gastrointestinal side effects[1][3].

Q: What are the challenges facing the celecoxib market? A: Challenges include competition from alternative therapies, regulatory scrutiny, price sensitivity, and potential side effects[1].

Q: How is the celecoxib API market expected to grow? A: The global celecoxib API market is expected to grow from US$ 58.9 million in 2023 to US$ 87.0 million by 2031, with a CAGR of 5.1% during the forecast period[4].

Cited Sources:

1. Marketresearchintellect: Celecoxib Market Size, Trends and Projections
2. PubMed: Economic Outcomes for Celecoxib: A Systematic Review
3. Verified Market Research: Celecoxib Market Size, Share, Trends & Forecast
4. InsightAce Analytic: Celecoxib API Market Growth Trajectory Poised for Expansion
5. Valuates Reports: Global Celecoxib API Market Insights, Forecast to 2030