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-four 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:	7
Raw Ingredient (Bulk) Api Vendors:	175
Clinical Trials:	240
Patent Applications:	75
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
University of Miami	Phase 3
University of Arizona	Phase 1
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	020998-002	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

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/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 CELEBREX

See the table below for patents covering CELEBREX around the world.

Country	Patent Number	Title	Estimated Expiration
China	1061036
Romania	118291	DERIVATI DE PIRAZOL 1,3,4,5 - TETRASUBSTITUITI SI COMPOZITIE FARMACEUTICA CARE II CONTINE (1, 3, 4, 5-TETRASUBSTITUTED PYRAZOL DERIVATIVES AND PHARMACEUTICAL COMPOSITION CONTAINING THE SAME)
South Korea	100263817
Japan	3025017
South Korea	100229343
China	100379727

Supplementary Protection Certificates for CELEBREX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0731795	SZ 4/2009	Austria		PRODUCT NAME: MAVACOXIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES
0731795	SPC004/2009	Ireland		SPC004/2009: 20091119, EXPIRES: 20191113
0731795	10075033	Germany		PRODUCT NAME: CELECOXIB; NAT. REGISTRATION NO/DATE: 48802.00.00 20000518; FIRST REGISTRATION: SE 14838 19991203
0731795	09C0007	France		PRODUCT NAME: MAVACOXIB; REGISTRATION NO/DATE: EU/2/08/084/001 20080909
0731795	CA 2009 00005	Denmark		PRODUCT NAME: MAVACOXIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF
0731795	SPC/GB09/010	United Kingdom		PRODUCT NAME: MAVACOXIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/2/08/084/001 20080909; UK EU/2/08/084/002 20080909; UK EU/2/08/084/003 20080909; UK EU/2/08/084/004 20080909; UK EU/2/08/084/005 20080909

CELEBREX Market Analysis and Financial Projection Experimental

Celebrex Market Dynamics and Financial Trajectory

Introduction to Celebrex

Celebrex, also known as celecoxib, is a nonsteroidal anti-inflammatory drug (NSAID) that selectively inhibits COX-2, an enzyme responsible for pain and inflammation. It is widely used for treating conditions such as arthritis, acute pain, and other inflammatory diseases.

Market Size and Forecast

The Celebrex market is experiencing significant growth, driven by several key factors. As of 2023, the market size was valued at USD 1640.9 million and is projected to reach USD 2866.8 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8.8% during the forecast period 2024-2031[1].

Drivers of Market Growth

Rising Healthcare Expenditure

Global increases in healthcare spending are a major driver for the Celebrex market. As healthcare systems worldwide focus on improving quality of care and patient outcomes, there is a corresponding rise in the use of effective medications like Celebrex to manage chronic pain. Higher healthcare budgets allow for improved patient services, with insurers more likely to cover innovative pain management therapies[1].

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 the drug's growing market share[4].

Increasing Prevalence of Arthritis

The rising incidence of arthritis globally is boosting the demand for Celebrex as an effective pain management medication. Arthritis and other inflammatory diseases are becoming more prevalent, particularly among the aging population, driving the need for medications like Celebrex[4].

Aging Population

The growing elderly population, especially in developed regions, is driving the demand for medications like Celebrex to manage age-related inflammatory conditions. This demographic shift is a key driver of the market's growth trajectory[4].

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 the drug, although it also introduces competitive pressure on branded versions[4].

Challenges and Restraints

Regulatory Challenges

The Celebrex market faces significant regulatory hurdles that can affect product availability and market growth. Stringent regulatory requirements for drug approval and safety monitoring impose lengthy testing and evaluation processes, which can delay the introduction of new celecoxib formulations. Ongoing scrutiny from regulatory bodies regarding cardiovascular risks associated with long-term use can also limit prescribing practices and market acceptance[1].

Competitive Generic Products

The increasing market presence of generic alternatives poses a substantial restraint on Celebrex sales. Once the patent protection for celecoxib lapses, generic drug manufacturers can offer cheaper versions of the medication, leading to a decline in the preference for branded Celebrex and impacting revenue streams for original manufacturers[1].

Pricing Pressure

The Celebrex market is subjected to significant pricing pressure, primarily driven by healthcare cost-containment measures and increased scrutiny on drug pricing. Payers, including insurers and government programs, push for lower prices and negotiate discounts, which can erode profit margins for manufacturers. The focus on value-based care has compelled healthcare providers to seek more cost-effective treatment alternatives, often opting for generics or non-COX-2 selective NSAIDs[1].

Adverse Effects and Safety Concerns

Despite its favorable safety profile, Celebrex is not without risks. Studies have shown an increased cardiovascular risk associated with high doses of the drug, which has led to regulatory scrutiny and changes in marketing strategies. For instance, Pfizer stopped advertising Celebrex to consumers following a cancer clinical trial that highlighted these risks[3].

Geographic Segmentation

The Celebrex market can be broadly segmented by geography, each region having its unique dynamics:

North America

In North America, particularly the United States, Celebrex is widely prescribed for conditions such as arthritis and acute pain. The strong healthcare infrastructure, high prevalence of chronic pain disorders, and robust insurance coverage support the growth of this market segment[1].

Europe

In Europe, the market is influenced by varying healthcare systems across countries. Nations like Germany, France, and the UK lead in prescription rates, with the European Medicines Agency’s stringent regulations ensuring safety and efficacy[1].

Asia-Pacific

The Asia-Pacific region is witnessing significant growth due to an increasing population, rising healthcare expenditure, and expanding medical facilities, particularly in countries like China and India[1].

Middle East and Africa

This region presents a diverse landscape where economic barriers and healthcare access vary greatly. However, with improving infrastructure, this market holds potential for growth[1].

Latin America

Latin America, with burgeoning healthcare needs and evolving pharmaceutical policies, is also emerging as a significant player in the Celebrex market[1].

Financial Performance of Key Players

Companies like Viatris, which manufacture and distribute Celebrex, have reported strong financial results. For example, Viatris reported total net sales of $3.83 billion in the fourth quarter of 2023, with adjusted EBITDA of $5.1 billion for the full year. The company's generics segment, which includes Celebrex, has seen consistent growth, although it faces challenges from pricing pressure and competition from generic alternatives[5].

Competitive Landscape

The Celebrex market is characterized by a competitive landscape with several major players. The market analysis includes a Porter’s Five Forces analysis, which elucidates the forces of buyers' bargaining power, suppliers' bargaining power, the threat of new entrants, the threat of substitutes, and the degree of competition within the market. The presence of alternative pain management therapies and medications poses a challenge to the growth of Celebrex market share[4].

Key Takeaways

• The Celebrex market is projected to grow significantly, driven by rising healthcare expenditure, a favorable safety profile, and an increasing prevalence of arthritis.
• Regulatory challenges, competitive generic products, and pricing pressure are key restraints.
• Geographic segmentation highlights varying market dynamics across regions.
• Major players like Viatris report strong financial performance but face challenges from competition and pricing pressure.

FAQs

What is the projected market size of Celebrex by 2031?

The Celebrex market is projected to reach USD 2866.8 million by 2031, growing at a CAGR of 8.8% during the forecast period 2024-2031[1].

What are the main drivers of the Celebrex market growth?

The main drivers include rising healthcare expenditure, a favorable safety profile compared to traditional NSAIDs, and the increasing prevalence of arthritis globally[1][4].

What are the significant challenges facing the Celebrex market?

The market faces regulatory challenges, competition from generic products, pricing pressure, and safety concerns related to cardiovascular risks[1][3].

How does geographic segmentation impact the Celebrex market?

Geographic segmentation reveals varying market dynamics, with North America and Europe being key markets due to strong healthcare infrastructure and high prevalence of chronic pain disorders, while the Asia-Pacific region shows significant growth potential[1].

What is the impact of generic versions on the Celebrex market?

The availability of generic Celecoxib versions has increased market accessibility and affordability but also introduces competitive pressure on branded versions, leading to a decline in preference for branded Celebrex[1][4].

Sources

1. Verified Market Research: Celecoxib Market Size, Share, Trends & Forecast[1].
2. Viatris Investor Relations: Viatris Reports Strong Fourth Quarter and Full Year 2022 Financial Results[2].
3. Genetic Engineering & Biotechnology News: Vioxx and Celebrex Bring Heat to the FDA[3].
4. Market Research Intellect: Global Celecoxib Market Size, Trends and Projections[4].
5. Viatris Newsroom: Viatris Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides 2024 Financial Guidance[5].