ROSIGLITAZONE MALEATE - Generic Drug Details

What are the generic sources for rosiglitazone maleate and what is the scope of patent protection?

Rosiglitazone maleate is the generic ingredient in two branded drugs marketed by Woodward and Ani Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for rosiglitazone maleate. There are six tentative approvals for this compound.

Summary for ROSIGLITAZONE MALEATE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	11
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	22
Patent Applications:	5,144
What excipients (inactive ingredients) are in ROSIGLITAZONE MALEATE?	ROSIGLITAZONE MALEATE excipients list
DailyMed Link:	ROSIGLITAZONE MALEATE at DailyMed

Recent Clinical Trials for ROSIGLITAZONE MALEATE

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

Sponsor	Phase
Mutual Pharmaceutical Company, Inc.	Phase 1
Cetero Research, San Antonio	Phase 1
GlaxoSmithKline	Phase 1

See all ROSIGLITAZONE MALEATE clinical trials

Generic filers with tentative approvals for ROSIGLITAZONE MALEATE

Applicant	Application No.	Strength	Dosage Form
		4MG	TABLET; ORAL
		2MG	TABLET; ORAL
		8MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for ROSIGLITAZONE MALEATE

A10BG	Thiazolidinediones
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for ROSIGLITAZONE MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	ROSIGLITAZONE MALEATE	rosiglitazone maleate	TABLET;ORAL	076747-001	Jan 25, 2013		DISCN	No	No
Ani Pharms	ROSIGLITAZONE MALEATE	rosiglitazone maleate	TABLET;ORAL	076747-002	Jan 25, 2013		DISCN	No	No
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-002	May 25, 1999		DISCN	Yes	No
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-004	May 25, 1999		DISCN	Yes	No

Expired US Patents for ROSIGLITAZONE MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-004	May 25, 1999	5,741,803*PED
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-003	May 25, 1999	5,002,953*PED
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-004	May 25, 1999	5,002,953*PED
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-002	May 25, 1999	5,002,953*PED

ROSIGLITAZONE MALEATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Rosiglitazone Maleate (Avandia)

Introduction

Rosiglitazone maleate, marketed under the brand name Avandia, is an antidiabetic drug in the thiazolidinedione class. It was developed and marketed by GlaxoSmithKline (GSK) for the treatment of type 2 diabetes. Here, we will explore the market dynamics and financial trajectory of this drug, highlighting its rise, challenges, and eventual decline.

Approval and Initial Success

Rosiglitazone maleate was first approved by the FDA on May 25, 1999. Initially, it was well-received in the medical community for its ability to improve insulin sensitivity by activating the peroxisome proliferator-activated receptor gamma (PPARγ)[3][4].

Peak Sales and Market Dominance

By 2006, Avandia had become one of the top-selling diabetes medications, with annual sales reaching approximately $2.5 billion. This success was largely due to its effectiveness in glycemic control and its widespread prescription by healthcare providers[1].

Controversy and Safety Concerns

However, the drug's success was short-lived. In May 2007, a meta-analysis published by Dr. Steven Nissen linked the use of rosiglitazone to an increased risk of heart attacks and cardiovascular deaths. This study, which included 42 trials (27 of which were unpublished), found a 1.4-fold increased risk of heart attacks associated with rosiglitazone compared to control groups[1].

Regulatory Actions and Market Impact

Following the meta-analysis, regulatory bodies took swift action. The FDA held a joint advisory committee meeting in July 2007, which concluded that the evidence indicated an increased risk of cardiovascular events associated with rosiglitazone. As a result, the FDA added a boxed warning to the drug's label regarding the risk of heart attacks and restricted its use[1].

In Europe, the European Medicines Agency (EMA) recommended suspending the drug in September 2010, citing that the benefits no longer outweighed the risks. Consequently, Avandia was withdrawn from the market in several countries, including the UK, Spain, India, New Zealand, and South Africa[1].

Financial Decline

The safety concerns and subsequent regulatory actions had a devastating impact on Avandia's sales. By 2012, annual sales had plummeted to just $9.5 million, a stark contrast to its peak in 2006. The drug's patent expired in 2012, further reducing its market value[1].

Litigation and Settlements

The controversy surrounding Avandia also led to numerous lawsuits against GSK. By March 2010, over 13,000 lawsuits had been filed, including a significant claim from Santa Clara County, California. GSK reached settlement agreements for many of these cases, agreeing to pay substantial amounts, such as $60 million to resolve 700 suits and approximately $460 million to settle another 10,000 lawsuits[1].

Comparative Cost-Effectiveness

Studies comparing rosiglitazone to its competitor, pioglitazone (Actos), highlighted the economic implications of the safety concerns. A cost-effectiveness analysis using the CORE Diabetes Model found that while pioglitazone had higher total direct costs, it also had lower complication costs and better long-term outcomes in terms of quality-adjusted life years (QALYs)[2].

Impact on GSK's Financials

The decline of Avandia significantly affected GSK's financial performance. The drop in sales from $2.2 billion in 2006 to $1.2 billion worldwide in 2009 was a substantial blow. The company also incurred significant legal and settlement costs related to the drug's safety issues[1].

Current Status

Today, rosiglitazone maleate is no longer a dominant player in the diabetes market. Its use is heavily restricted, and it is largely overshadowed by other antidiabetic medications with better safety profiles. The financial trajectory of Avandia serves as a cautionary tale about the importance of drug safety and the rapid changes that can occur in the pharmaceutical market.

Key Takeaways

• Approval and Initial Success: Rosiglitazone maleate was approved in 1999 and quickly became a top-selling diabetes medication.
• Safety Concerns: Meta-analyses in 2007 linked the drug to increased cardiovascular risks, leading to regulatory actions and market restrictions.
• Financial Decline: Sales plummeted from $2.5 billion in 2006 to $9.5 million in 2012.
• Litigation: GSK faced numerous lawsuits and paid substantial settlements.
• Comparative Cost-Effectiveness: Studies showed pioglitazone to be more cost-effective in the long term.
• Impact on GSK: The decline of Avandia affected GSK's financial performance significantly.

FAQs

What is rosiglitazone maleate used for?

Rosiglitazone maleate, marketed as Avandia, is used for the treatment of type 2 diabetes to improve glycemic control by enhancing insulin sensitivity.

What are the main safety concerns associated with rosiglitazone?

The primary safety concerns include an increased risk of heart attacks, cardiovascular deaths, heart failure, and myocardial ischemic events.

How did regulatory actions affect the market for Avandia?

Regulatory bodies added a boxed warning to the drug's label and restricted its use, leading to its withdrawal from several markets and a significant decline in sales.

What was the financial impact of the decline of Avandia on GSK?

The decline resulted in a substantial drop in sales from $2.2 billion in 2006 to $9.5 million in 2012, along with significant legal and settlement costs.

How does rosiglitazone compare to its competitor, pioglitazone?

Studies have shown that pioglitazone has a better safety profile and is more cost-effective in the long term, with lower complication costs and better outcomes in terms of QALYs.

What is the current status of Avandia in the market?

Avandia is no longer a dominant player in the diabetes market due to its restricted use and the availability of safer alternatives.