BEXTRA Drug Patent Profile

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

Bextra is a drug marketed by Gd Searle and is included in one NDA.

The generic ingredient in BEXTRA is valdecoxib. Additional details are available on the valdecoxib profile page.

Summary for BEXTRA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	3
Patent Applications:	4,408
DailyMed Link:	BEXTRA at DailyMed

Recent Clinical Trials for BEXTRA

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

Sponsor	Phase
Pfizer	Phase 4
Pfizer	Phase 3

See all BEXTRA clinical trials

US Patents and Regulatory Information for BEXTRA

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 BEXTRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gd Searle	BEXTRA	valdecoxib	TABLET;ORAL	021341-002	Nov 16, 2001	5,633,272
Gd Searle	BEXTRA	valdecoxib	TABLET;ORAL	021341-002	Nov 16, 2001	7,135,489
Gd Searle	BEXTRA	valdecoxib	TABLET;ORAL	021341-003	Nov 16, 2001	7,135,489
Gd Searle	BEXTRA	valdecoxib	TABLET;ORAL	021341-003	Nov 16, 2001	5,633,272

EU/EMA Drug Approvals for BEXTRA

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	Withdrawn	no	no	no	2003-03-27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	Withdrawn	no	no	no	2003-03-27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	Withdrawn	no	no	no	2003-03-27

International Patents for BEXTRA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1283203
Japan	2005015497	CRYSTAL FORM OF 4-[5-METHYL-3-PHENYLISOXAZOL-4-YL]BENZENESULFONAMIDE
Norway	990541
Turkey	9900298

Supplementary Protection Certificates for BEXTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0809636	300128	Netherlands
0809636	91024	Luxembourg		91024, EXPIRES: 20180327
0809636	C300128	Netherlands		PRODUCT NAME: VALDECOXIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH ACCEPTABEL ZOUT; REGISTRATION NO/DATE: EU/1/02/239/001 - EU/1/02/239/024, EU/1/02/242/001 - EU/1/02/242/024, EU/1/02/244/001 - EU/1/02/244/024 20030317
0809636	SPC/GB03/022	United Kingdom		PRODUCT NAME: VALDECOXIB OR ITS PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/02/244/001-024 20030327; UK EU/1/02/239/001-024 20030327; UK EU/1/02/242/001-024 20030327

Market Dynamics and Financial Trajectory of Bextra

Introduction

Bextra, a Cox-2 inhibitor developed by Pfizer, was introduced to the market in November 2001 as a safer alternative to traditional nonsteroidal anti-inflammatory drugs (NSAIDs). This article delves into the market dynamics and financial trajectory of Bextra, highlighting its rise, fall, and the subsequent legal and financial implications.

Market Entry and Initial Success

Bextra was one of three Cox-2 inhibitors approved by the FDA, following Celebrex in December 1998 and Vioxx in May 1999. These drugs were heavily advertised and quickly gained market share due to their perceived safety benefits over traditional NSAIDs. By 2003, the Cox-2 inhibitor class had amassed significant sales, with Bextra contributing to this success, albeit to a lesser extent than Celebrex and Vioxx[1].

Advertising and Market Impact

The success of Bextra and other Cox-2 inhibitors was partly driven by extensive advertising efforts, including detailing, direct-to-consumer advertising, and journal advertising. These campaigns were effective in increasing drug sales, although academic articles and FDA updates had less impact on prescription decisions[1].

Safety Concerns and Market Decline

The market dynamics for Bextra began to shift dramatically with the emergence of safety concerns. In September 2004, Merck withdrew Vioxx due to its association with severe cardiovascular risks. This event raised concerns about the entire Cox-2 inhibitor class, including Bextra. By April 2005, the FDA cited cardiovascular risks and the potential for serious, sometimes fatal, skin reactions, leading Pfizer to suspend sales of Bextra in the United States and the European Union[4].

Financial Impact of Withdrawal

The withdrawal of Bextra had significant financial implications for Pfizer. The drug, which had been among Pfizer's best-selling medications, saw its sales plummet. The company faced mounting legal and financial challenges, including shareholder lawsuits and regulatory actions.

Legal and Financial Settlements

Pfizer agreed to several settlements related to Bextra and Celebrex. In 2009, the company settled a U.S. Department of Justice probe into its marketing of Bextra and other drugs for $2.3 billion. Later, Pfizer settled a decade-old shareholder lawsuit tied to Bextra and Celebrex for $486 million[2].

In another settlement, Pfizer agreed to pay $894 million to settle lawsuits related to Bextra and Celebrex, mirroring Merck's approach to settling Vioxx lawsuits[5].

Impact on Pfizer's Financials

The controversies surrounding Bextra and Celebrex led to substantial financial burdens for Pfizer. The settlements and legal fees, combined with the decline in sales due to safety concerns and generic competition, significantly impacted the company's financial performance. For example, Celebrex sales dropped 18% in the face of generic competition, despite still generating $183 million in Q2 of the relevant year[2].

R&D and Market Strategy Adjustments

Following the negative shocks to Bextra and other Cox-2 inhibitors, pharmaceutical firms like Pfizer adjusted their R&D investments and market strategies. Firms increased R&D expenditures in the affected therapeutic areas, often through acquiring external innovations rather than developing novel projects internally. This strategy was particularly evident in firms with weak internal research pipelines[3].

Competitor Responses

Competing firms responded to the negative shocks by reallocating their R&D resources away from the affected therapeutic areas. Instead of increasing expenditures to replace the beleaguered drugs, they were more likely to shut down projects in those areas and focus on other therapeutic areas[3].

Regulatory Changes and Warnings

The FDA implemented several regulatory changes in response to the safety concerns. Bextra was withdrawn, and Celebrex, along with other prescription NSAID COX-2 inhibitors, was required to carry a black-box warning about cardiovascular and gastrointestinal risks. Patients were also provided with a special pamphlet explaining these warnings[4].

Consumer and Physician Feedback

The diffusion of Cox-2 inhibitors, including Bextra, was influenced by patient feedback and academic articles. While patient feedback encouraged doctors to switch from traditional NSAIDs to Cox-2 inhibitors, academic articles had a detrimental effect on market share, reflecting different dimensions of drug quality[1].

Key Takeaways

• Market Entry and Success: Bextra entered the market in 2001 and initially saw success due to heavy advertising and perceived safety benefits.
• Safety Concerns: The drug was withdrawn in 2005 due to cardiovascular and skin reaction risks.
• Financial Impact: The withdrawal led to significant financial losses and legal settlements for Pfizer.
• R&D Adjustments: Pfizer and other firms increased R&D investments in affected therapeutic areas through external acquisitions.
• Regulatory Changes: The FDA implemented black-box warnings and patient education pamphlets for remaining Cox-2 inhibitors.
• Consumer and Physician Feedback: Patient feedback and academic articles played contrasting roles in the market dynamics of Bextra.

FAQs

Q: Why was Bextra withdrawn from the market? A: Bextra was withdrawn due to cardiovascular risks and the potential for serious, sometimes fatal, skin reactions as cited by the FDA[4].

Q: How did the withdrawal of Vioxx impact Bextra? A: The withdrawal of Vioxx raised concerns about the entire Cox-2 inhibitor class, including Bextra, leading to a decline in its market share and eventual withdrawal[1].

Q: What were the financial implications for Pfizer following the Bextra controversy? A: Pfizer faced significant financial burdens, including settlements totaling nearly $3 billion and declining sales due to safety concerns and generic competition[2][5].

Q: How did pharmaceutical firms adjust their R&D strategies after the Bextra controversy? A: Firms increased R&D expenditures in affected therapeutic areas, often through acquiring external innovations rather than developing novel projects internally[3].

Q: What regulatory changes were implemented following the Bextra controversy? A: The FDA required black-box warnings on remaining Cox-2 inhibitors and provided patient education pamphlets to explain the risks associated with these drugs[4].