AVANDARYL Drug Patent Profile

Which patents cover Avandaryl, and what generic alternatives are available?

Avandaryl is a drug marketed by Sb Pharmco and is included in one NDA.

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

Summary for AVANDARYL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	1
Patent Applications:	3,016
DailyMed Link:	AVANDARYL at DailyMed

Recent Clinical Trials for AVANDARYL

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

Sponsor	Phase
GlaxoSmithKline	Phase 3

See all AVANDARYL clinical trials

Paragraph IV (Patent) Challenges for AVANDARYL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVANDARYL	Tablets	glimepiride; rosiglitazone maleate	8 mg/2 mg 8 mg/4 mg	021700	1	2008-05-30
AVANDARYL	Tablets	glimepiride; rosiglitazone maleate	1 mg/4 mg 2 mg/4 mg 4 mg/4 mg	021700	1	2006-12-22

US Patents and Regulatory Information for AVANDARYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-001	Nov 23, 2005		DISCN	Yes	No
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-003	Nov 23, 2005		DISCN	Yes	No
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-002	Nov 23, 2005		DISCN	Yes	No
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-004	Mar 30, 2007		DISCN	Yes	No
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-005	Mar 30, 2007		DISCN	Yes	No

Expired US Patents for AVANDARYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-003	Nov 23, 2005
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-002	Nov 23, 2005
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-003	Nov 23, 2005
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-001	Nov 23, 2005
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-004	Mar 30, 2007
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-003	Nov 23, 2005
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-002	Nov 23, 2005

International Patents for AVANDARYL

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

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	1607	Thiazolidinedione derivative and its use as antidiabetic.
South Africa	200108718	Thiazolidinedione derivative and its use as antidiabetic.
Algeria	3164	Nouvel agent pharmaceutique.
Norway	2001005
Japan	2828777
Denmark	0658161
Czech Republic	287473	Salt of maleic acid and a 5-[4-[2-(N-methyl-N-(2-pyridyl)amino)ethoxy]benzyl]thiazolidine-2,4-dione, process of its preparation, pharmaceutical preparation in which this compound is comprised as well as use thereof

Supplementary Protection Certificates for AVANDARYL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0658161	C300035	Netherlands		PRODUCT: ROSIGLITAZONE,MALEAAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT.
0658161	SPC/GB01/003	United Kingdom		PRODUCT NAME: N-(4-(2(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY)BENZYL)THIAZOLIDINE-2,4-DIONE MALEIC ACID, "ROSIGLITAZONE MALEATE", ITS TAUTOMERS AND PHARMACEUTICALLY ACCEPTABLE SOLVATES; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711
0658161	CA 2001 00001	Denmark
0306228	SPC/GB01/002	United Kingdom		PRODUCT NAME: 5-(4-(2-(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY) BENZYL)-2,4-THIAZOLIDINEDIONE, "ROSIGLITAZONE" ITS TAUTOMERS, PHARMACEUTICALLY ACCEPTABLE SALTS, SUCH AS THE MALEATE, AND PHARMACEUTICALLY ACCEPTABLE SOLVATES.; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711
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
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

AVANDARYL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Avandaryl (Rosiglitazone and Glimepiride)

Introduction

Avandaryl, a combination drug containing rosiglitazone and glimepiride, is used to treat type 2 diabetes. This article delves into the market dynamics and financial trajectory of Avandaryl, highlighting its rise, fall, and the subsequent regulatory and market changes.

Market Launch and Initial Success

Release and Early Adoption

Avandaryl was introduced to the market as part of the thiazolidinedione class of antidiabetic drugs, with rosiglitazone (marketed as Avandia) being the key component. Initially, the drug saw significant success, particularly in the early 2000s, as it was marketed by GlaxoSmithKline (GSK) as a stand-alone drug or in combination with other antidiabetic medications like metformin or glimepiride[1].

Peak Sales

The peak sales of Avandia, which includes Avandaryl, were achieved in 2006, with annual sales reaching approximately $2.5 billion. This period marked the height of the drug's commercial success, driven by its effectiveness as an insulin sensitizer[1].

Safety Concerns and Regulatory Scrutiny

Cardiovascular Risks

In 2007, a meta-analysis linked the use of rosiglitazone to an increased risk of heart attacks, which significantly impacted the drug's market performance. This revelation led to a sharp decline in sales, with US sales dropping by 22% in the second quarter of 2007 compared to the same period in 2006[1].

FDA Panel and Regulatory Actions

Following the safety concerns, the FDA convened a panel to review the drug's safety profile. In July 2010, the panel voted to keep Avandia on the market but with revised warning labels. However, controversy arose due to a panel member's conflict of interest, having been a paid speaker for GSK. This led to further scrutiny and public distrust[1].

International Regulatory Actions

Regulatory bodies in other countries also took action. In the UK, the Commission on Human Medicines recommended withdrawing Avandia from the market in July 2010 due to its risks outweighing its benefits. Similarly, in New Zealand and South Africa, Avandia was withdrawn from the market due to safety concerns[1].

Financial Impact

Decline in Sales

The safety concerns and subsequent regulatory actions led to a drastic decline in sales. By 2012, the annual sales of Avandia had plummeted to just $9.5 million, a significant drop from its peak of $2.5 billion in 2006. Worldwide sales for 2009 totaled $1.2 billion, still a substantial decline from previous years[1].

Financial Performance of GSK

The financial impact on GSK was considerable. The company faced multiple challenges, including legal issues, warning letters from the FDA, and a significant backlash over the drug's safety. These factors contributed to the decline in GSK's revenue from Avandia and related products[1].

Reevaluation and Removal of Restrictions

FDA Reevaluation

In June 2013, an FDA Advisory Committee reevaluated the data, including a re-adjudicated RECORD trial, and found no evidence of increased cardiovascular risk associated with Avandia. Consequently, the FDA removed the marketing restrictions on Avandia in November 2013[1].

Post-Restriction Market Dynamics

Although the restrictions were lifted, the market dynamics for Avandaryl had already been significantly altered. The drug never regained its pre-2007 market share, and its use became more cautious and limited.

Current Market Status

Limited Use

Today, Avandaryl is used under strict guidelines and with careful patient selection. The drug's label includes detailed warnings about its potential cardiovascular risks, which has limited its prescription and use compared to other antidiabetic medications[4].

Financial Trajectory

The financial trajectory of Avandaryl is characterized by a sharp decline following the safety concerns and regulatory actions. While the removal of marketing restrictions in 2013 allowed for some recovery, the drug's sales never approached their pre-2007 levels. The financial performance of GSK and the overall market for Avandaryl have been permanently impacted by these events.

Key Takeaways

• Initial Success: Avandaryl saw significant success upon its introduction due to its effectiveness as an insulin sensitizer.
• Safety Concerns: The drug's market was severely impacted by safety concerns related to cardiovascular risks.
• Regulatory Scrutiny: FDA panels and international regulatory bodies took action, leading to a decline in sales and market share.
• Financial Impact: The financial performance of GSK and the overall market for Avandaryl were significantly affected.
• Current Status: Avandaryl is used under strict guidelines with limited market share.

FAQs

What is Avandaryl?

Avandaryl is a combination drug containing rosiglitazone and glimepiride, used to treat type 2 diabetes.

Why did Avandaryl's sales decline?

Avandaryl's sales declined significantly due to safety concerns related to an increased risk of heart attacks associated with rosiglitazone.

What regulatory actions were taken against Avandaryl?

Regulatory bodies, including the FDA, imposed restrictions and considered withdrawing the drug from the market due to safety concerns. However, restrictions were later lifted in 2013.

How has the market for Avandaryl changed?

The market for Avandaryl has been permanently altered, with the drug now used under strict guidelines and with careful patient selection.

What is the current financial status of Avandaryl?

The financial performance of Avandaryl has not recovered to its pre-2007 levels, with the drug's sales remaining significantly lower due to ongoing safety concerns and regulatory oversight.

Sources

1. Wikipedia: Rosiglitazone
2. Investing.com: Avadel Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2024 Financial Results
3. Investing.com: Avadel shares price target cut, maintains buy on Q3 results
4. FDA: Updated Risk Evaluation and Mitigation Strategy (REMS) - FDA