Valdecoxib - Generic Drug Details

What are the generic drug sources for valdecoxib and what is the scope of patent protection?

Valdecoxib is the generic ingredient in one branded drug marketed by Gd Searle and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for valdecoxib

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	30
Patent Applications:	7,355
DailyMed Link:	valdecoxib at DailyMed

Recent Clinical Trials for valdecoxib

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

Sponsor	Phase
University of Sao Paulo	Phase 4
University of Pennsylvania	Phase 1
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1

See all valdecoxib clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for valdecoxib

M01AH	Coxibs
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

US Patents and Regulatory Information for valdecoxib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gd Searle	BEXTRA	valdecoxib	TABLET;ORAL	021341-002	Nov 16, 2001		DISCN	No	No
Gd Searle	BEXTRA	valdecoxib	TABLET;ORAL	021341-003	Nov 16, 2001		DISCN	No	No

Expired US Patents for valdecoxib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gd Searle	BEXTRA	valdecoxib	TABLET;ORAL	021341-002	Nov 16, 2001
Gd Searle	BEXTRA	valdecoxib	TABLET;ORAL	021341-002	Nov 16, 2001
Gd Searle	BEXTRA	valdecoxib	TABLET;ORAL	021341-003	Nov 16, 2001
Gd Searle	BEXTRA	valdecoxib	TABLET;ORAL	021341-003	Nov 16, 2001

EU/EMA Drug Approvals for valdecoxib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pharmacia - Pfizer EEIG	Bextra	valdecoxib	EMEA/H/C/000431 Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of primary dysmenorrhoea.The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risk (see sections 4.3, 4.4).	Withdrawn	no	no	no	2003-03-27
Pharmacia Europe EEIG	Valdyn	valdecoxib	EMEA/H/C/000432 Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of primary dysmenorrhoea.	Withdrawn	no	no	no	2003-03-27
Pfizer Limited	Valdyn (previously Kudeq)	valdecoxib	EMEA/H/C/000437 Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of primary dysmenorrhoea.	Withdrawn	no	no	no	2003-03-27

Market Dynamics and Financial Trajectory of Valdecoxib

Introduction

Valdecoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, was once a promising drug in the management of osteoarthritis, dysmenorrhea, and acute pain. However, its market trajectory was significantly impacted by safety concerns and regulatory actions.

Mechanism of Action and Clinical Use

Valdecoxib works by selectively inhibiting the COX-2 enzyme, which is involved in the mediation of inflammation and pain. It was used for its anti-inflammatory, analgesic, and antipyretic activities, particularly in treating osteoarthritis and dysmenorrhea[2].

Market Entry and Initial Reception

When valdecoxib was introduced, it was seen as a safer alternative to non-selective NSAIDs due to its reduced risk of gastrointestinal side effects. Clinical trials showed that valdecoxib had lower total healthcare costs compared to diclofenac, primarily due to reduced hospitalization costs for gastrointestinal serious adverse events (SAEs)[1].

Safety Concerns and Regulatory Actions

Despite its initial promise, valdecoxib faced severe backlash due to concerns about its cardiovascular safety profile. Similar to other COX-2 inhibitors like Vioxx, valdecoxib was associated with an increased risk of heart attacks and strokes. This led to its withdrawal from the markets in the U.S., Canada, and the EU in 2005[2].

Financial Impact of Withdrawal

The withdrawal of valdecoxib had significant financial implications. The drug's manufacturer, Pfizer, faced substantial costs associated with the withdrawal, including legal settlements and loss of revenue. For instance, the total costs accrued due to excess cardiovascular events and premature deaths attributed to valdecoxib were estimated to be around $4.2 billion for cardiovascular disease and $50.5 billion for premature deaths[3].

Market Dynamics Post-Withdrawal

The COX-2 selective NSAIDs market, which includes drugs like valdecoxib, has been influenced by several dynamics:

Drivers

• The increasing prevalence of chronic inflammatory diseases drives demand for COX-2 selective NSAIDs.
• Advancements in pharmaceutical research aim to enhance efficacy and reduce side effects of these drugs[4].

Restraints

• Strict regulatory policies and the cardiovascular risks associated with COX-2 inhibitors limit their adoption.
• Public perception and awareness issues affect market acceptance of these drugs[4].

Opportunities

• Development of novel COX-2 selective NSAIDs with improved safety profiles presents opportunities for market growth.
• Integrating COX-2 inhibitors with complementary therapies and advancing biodegradable delivery mechanisms can spur innovation[4].

Current Market Scenario

The COX-2 selective NSAIDs market continues to grow, albeit cautiously, due to ongoing safety concerns. The market size was estimated to be $8.19 billion in 2024 and is expected to reach $11.33 billion by 2030, growing at a CAGR of 5.42%[4].

Financial Trajectory

The financial trajectory of valdecoxib itself is no longer a factor in the current market, given its withdrawal. However, the broader COX-2 selective NSAIDs market faces significant financial challenges and opportunities:

• Revenue Growth: The market is expected to continue growing driven by the increasing prevalence of chronic diseases and advancements in drug delivery systems.
• Costs and Liabilities: The historical costs associated with the withdrawal of drugs like valdecoxib and Vioxx serve as a cautionary tale, highlighting the importance of rigorous post-marketing surveillance and safety monitoring[4].

Key Takeaways

• Valdecoxib was withdrawn from the market due to cardiovascular safety concerns.
• The drug's withdrawal had significant financial implications for its manufacturer.
• The broader COX-2 selective NSAIDs market continues to grow but faces challenges related to safety and regulatory scrutiny.
• Innovations in drug delivery and safety profiles are crucial for the future growth of this market segment.

FAQs

Q: What was the primary reason for the withdrawal of valdecoxib from the market? A: Valdecoxib was withdrawn due to concerns about its increased risk of heart attacks and strokes.

Q: How did the withdrawal of valdecoxib impact Pfizer financially? A: The withdrawal led to substantial costs, including legal settlements and loss of revenue, with estimated costs of $4.2 billion for cardiovascular disease and $50.5 billion for premature deaths.

Q: What is the current market size of COX-2 selective NSAIDs? A: The market size was estimated to be $8.19 billion in 2024.

Q: What is the expected growth rate of the COX-2 selective NSAIDs market? A: The market is expected to grow at a CAGR of 5.42% until 2030.

Q: What are the main drivers of the COX-2 selective NSAIDs market? A: The main drivers include the increasing prevalence of chronic inflammatory diseases and advancements in pharmaceutical research.

Cited Sources:

1. Economic evaluation of oral valdecoxib versus diclofenac in the treatment of rheumatoid arthritis - PubMed.
2. Valdecoxib: Uses, Interactions, Mechanism of Action - DrugBank.
3. Patent Monopolies and the Costs of Mismarketing Drugs - CEPR.
4. COX-2 Selective NSAIDs Market Research Report 2025-2030 - GlobeNewswire.