AVANDIA Drug Patent Profile

Which patents cover Avandia, and when can generic versions of Avandia launch?

Avandia is a drug marketed by Woodward and is included in one NDA.

The generic ingredient in AVANDIA is rosiglitazone maleate. There are twelve drug master file entries for this compound. Additional details are available on the rosiglitazone maleate profile page.

Summary for AVANDIA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	62
Drug Prices:	Drug price information for AVANDIA
What excipients (inactive ingredients) are in AVANDIA?	AVANDIA excipients list
DailyMed Link:	AVANDIA at DailyMed

See drug prices for AVANDIA

Recent Clinical Trials for AVANDIA

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

Sponsor	Phase
Dan Zandberg	Phase 2
University Health Network, Toronto	N/A
Barcelona Institute for Global Health	N/A

See all AVANDIA clinical trials

US Patents and Regulatory Information for AVANDIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-002	May 25, 1999		DISCN	Yes	No
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-003	May 25, 1999		DISCN	Yes	No
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-004	May 25, 1999		DISCN	Yes	No

Expired US Patents for AVANDIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-003	May 25, 1999
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-004	May 25, 1999
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-002	May 25, 1999
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-003	May 25, 1999

International Patents for AVANDIA

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

Country	Patent Number	Title	Estimated Expiration
Australia	674880
South Korea	20080081099
South Africa	200108718	Thiazolidinedione derivative and its use as antidiabetic.
Canada	1339902	COMPOSES INTERMEDIAIRES NOUVEAUX POUR LA PREPARATION DE DERIVES DE LA THIAZOLIDINEDIONE SUBSTITUES (NOVEL INTERMEDIATES FOR PREPARING SUBSTITUDES THIAZOLIDINEDIONE DERIVATIVES)

Supplementary Protection Certificates for AVANDIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0658161	39/2000	Austria		PRODUCT NAME: ROSIGLITAZONE MALEAT; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
0658161	SPC001/2001	Ireland		SPC001/2001: 20050808, EXPIRES: 20140928
0306228	C300034	Netherlands		PRODUCT NAME: ROSIGLITAZONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT, IN HET BIJZONDER ROSIGLITAZONE MALEAAT; REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711
0658161	01C0002	France		PRODUCT NAME: MALEATE DE ROSIGLITAZONE OU L UN DE SES ISOMERES OU UNE DE SES FORMES TAUTOMERES ET/OU UN DE SES SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/00/137/001 DU 20000711; REGISTRATION NO/DATE AT EEC: IKS Nø 55 176 DU 19990929

Market Dynamics and Financial Trajectory for AVANDIA (Rosiglitazone)

Last updated: July 28, 2025

Introduction

AVANDIA (rosiglitazone), a thiazolidinedione antidiabetic agent developed by GlaxoSmithKline (GSK), has historically played a significant role in the management of type 2 diabetes mellitus (T2DM). Launched in the late 1990s, AVANDIA was initially celebrated for its efficacy in improving insulin sensitivity and glycemic control. However, safety concerns, regulatory actions, and evolving market dynamics have profoundly influenced its commercial trajectory. This analysis explores the market forces shaping AVANDIA’s current status, its financial implications, and future prospects within the global diabetes therapeutics landscape.

Market Overview and Initial Commercial Success

When AVANDIA was introduced in 1999, it rapidly became a cornerstone therapy for T2DM, targeting insulin resistance—a core pathophysiological aspect of the disease. Its popularity was driven by its ability to lower blood glucose levels effectively, often as monotherapy or combined with other antidiabetic agents such as metformin and sulfonylureas.

At its peak, AVANDIA generated considerable revenue for GSK, with annual sales exceeding €1 billion regionally, particularly prevalent in North America and Europe. The drug's success was bolstered by the rising global prevalence of T2DM, projected to reach 700 million cases by 2045 according to the International Diabetes Federation (IDF)[1]. As such, AVANDIA benefited from a favorable market environment characterized by high demand for effective glycemic control options.

Regulatory Challenges and Safety Concerns

In the early 2000s, emerging data highlighted potential cardiovascular risks associated with rosiglitazone, notably increased myocardial infarction (MI) incidence. These concerns resulted from meta-analyses, including a pivotal 2007 report by the New England Journal of Medicine, which suggested a statistically significant increase in MI risk[2].

Regulatory agencies responded decisively:

• United States (FDA): Issued a restricted label warning in 2008, limiting rosiglitazone's use, especially restricting its use in patients with existing cardiovascular disease. The FDA also suspended its approval in 2010 due to safety signals but later eased restrictions after further review[3].

• European Union (EMA): Implemented a stricter ban, suspending marketing authorization in 2010, citing cardiovascular safety concerns[4].

The regulatory actions precipitated a sharp decline in AVANDIA’s market share. Volume declines were compounded by the emergence of alternative therapies such as SGLT2 inhibitors and GLP-1 receptor agonists, which demonstrated favorable safety profiles.

Market Impact and Financial Trajectory Post-Controversy

Following the regulatory restrictions, AVANDIA's revenue plummeted. GSK’s sales figures reflected this downturn, with annual sales dropping by approximately 70–80% between 2008 and 2013. Reports indicated revenues falling to critically low levels, around €100–200 million worldwide, with substantial revenue loss in core markets[5].

In response to declining sales, GSK implemented strategic measures including:

• Market withdrawals in some regions (e.g., the EU).

• Legal settlements: In 2010, GSK faced numerous lawsuits related to AVANDIA, resulting in multi-billion-dollar settlements over claims of adverse effects and inadequate warnings.

• Product discontinuation: GSK gradually withdrew AVANDIA products from multiple markets.

Despite this, the drug maintained residual revenues, largely from legacy prescriptions and markets with less restrictive regulatory environments. Notably, in the United States, some formulations remained temporarily available through certain channels until final withdrawal.

Evolving Market Dynamics and Resurgence Factors

Over recent years, the market for diabetes medications has experienced transformative shifts:

• Emergence of novel agents: SGLT2 inhibitors (e.g., empagliflozin, canagliflozin) and GLP-1 receptor agonists (e.g., semaglutide, liraglutide) offer improved safety and additional cardiovascular benefits[6].

• Regulatory tightening: Stringent safety requirements have driven innovation but have also limited the use of riskier agents.

• Biological insights: Better understanding of T2DM pathophysiology leads to precision medicine approaches, favoring drugs with robust safety profiles.

Given this context, AVANDIA’s original mechanism—enhancing insulin sensitivity—is now effectively addressed by newer molecules with better safety profiles. Consequently, market dynamics favor agents that demonstrate cardiovascular benefits and weigh safety heavily.

Potential Re-Entry and Off-Patent Opportunities

Although GSK permanently withdrew AVANDIA in many markets, the possibility of re-entry exists, especially through:

• Generic manufacturing: Once patent protections expire, generic rosiglitazone formulations could re-enter markets, especially in regions with less regulatory stringency or where affordability is paramount.

• Re-positioning: GSK or other entities could explore reformulations or controlled-release mechanisms, coupled with cardio-protective claims, leveraging post-market studies to mitigate safety concerns.

• Research revival: Ongoing investigations into thiazolidinediones suggest potential in combination therapies or modifications that could lessen adverse effects. However, such efforts face regulatory and market obstacles.

Financial Trajectory and Investment Outlook

Post-2008, AVANDIA’s commercial viability diminished sharply, leading to negligible revenue streams in most developed markets. Industry analysts project that, absent significant reformulation or indication expansion, the drug’s financial contribution will remain minimal.

Nevertheless, in emerging markets with less stringent regulatory oversight and high diabetic prevalence, rosiglitazone-based generics may retain commercial relevance. Market analysts estimate that, in such regions, low-cost generics could generate annual revenues of up to €50 million, primarily driven by affordability rather than innovation.

Future investment in AVANDIA alternatives appears unlikely unless significant safety improvements emerge, given the entrenched market preference for newer agents with proven cardiovascular benefits. Indeed, the current epidemiological trend prioritizes medications that demonstrate both glycemic control and cardioprotection.

Conclusion: Market Outlook Summary

• Regulatory and safety issues significantly curtailed AVANDIA’s market presence, with global sales collapsing post-2008.

• Market dynamics have shifted toward agents with demonstrated cardiovascular benefit, overshadowing rosiglitazone’s original profile.

• Opportunities for resurgence are limited, mainly confined to generic markets or niche indications within economically constrained regions.

• Investment and development focus increasingly favor newer, safer, and more efficacious agents, rendering AVANDIA a legacy product with minimal future growth prospects.

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Key Takeaways

• Regulatory safety concerns have profoundly impacted AVANDIA’s market penetration, leading to withdrawal in multiple markets and significant revenue decline.

• The evolving landscape of diabetes treatment prioritizes medications with proven cardiovascular benefits, diminishing AVANDIA’s commercial relevance.

• Despite past setbacks, AVANDIA's potential remains primarily in generic form and in emerging markets, where affordability outweighs safety profile considerations.

• Future development efforts are unlikely to revisit rosiglitazone unless substantial safety enhancements or novel indications are identified.

• Stakeholders should monitor the repositioning of thiazolidinediones and the regulatory environment, as these factors could influence niche market opportunities.

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Frequently Asked Questions (FAQs)

1. What caused AVANDIA’s decline in the global market?
Safety concerns regarding cardiovascular risks, chiefly increased myocardial infarction risk highlighted in 2007, prompted regulatory restrictions, market withdrawals, and ultimately led to a sharp decline in sales.

2. Are there ongoing legal settlements related to AVANDIA?
Yes. GSK faced numerous lawsuits alleging inadequate warnings about heart risks, leading to multi-billion-dollar settlements in the United States.

3. Can AVANDIA be used today for any specific indications?
In most markets, AVANDIA has been withdrawn or restricted. In select regions, generic rosiglitazone may still be prescribed for T2DM, primarily where regulatory restrictions are less stringent.

4. Is there any renewed scientific interest in rosiglitazone?
While research continues into thiazolidinediones, safety issues limit enthusiasm. Some studies explore modified formulations or combination therapies, but these are not mainstream.

5. What is the future outlook for rosiglitazone-based drugs?
Their future hinges on safety profile improvements and potential niche applications, but mainstream market prospects remain limited due to the dominance of safer, more effective alternatives with demonstrated cardiovascular benefits.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 10th Edition. 2021.
[2] Nissen SE et al. "Comparison of Cardiovascular Events Associated With Rosiglitazone and Other Antidiabetic Drugs." NEJM, 2007.
[3] FDA. "FDA Warns About Risks of Heart Failure with Antidiabetic Drugs Pioglitazone and Rosiglitazone." 2008.
[4] EMA. "European Medicines Agency Suspends Rosiglitazone." 2010.
[5] GSK Annual Reports. Various years.
[6] American Diabetes Association. "Standards of Medical Care in Diabetes," Diabetes Care, 2022.