AVANDAMET Drug Patent Profile

When do Avandamet patents expire, and what generic alternatives are available?

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

The generic ingredient in AVANDAMET is metformin hydrochloride; rosiglitazone maleate. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; rosiglitazone maleate profile page.

Summary for AVANDAMET

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	14
Patent Applications:	4,562
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVANDAMET
What excipients (inactive ingredients) are in AVANDAMET?	AVANDAMET excipients list
DailyMed Link:	AVANDAMET at DailyMed

Recent Clinical Trials for AVANDAMET

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
Susan G. Komen Breast Cancer Foundation	Phase 1
M.D. Anderson Cancer Center	Phase 1

See all AVANDAMET clinical trials

Paragraph IV (Patent) Challenges for AVANDAMET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVANDAMET	Tablets	metformin hydrochloride; rosiglitazone maleate	1 mg/ 500 mg, 2 mg/ 500mg 4 mg/ 500 mg 2 mg/ 1000 mg 4 mg/ 1000 mg	021410	1	2004-10-22

US Patents and Regulatory Information for AVANDAMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-004	Aug 25, 2003		DISCN	Yes	No
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-002	Oct 10, 2002		DISCN	Yes	No
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-005	Aug 25, 2003		DISCN	Yes	No
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-001	Oct 10, 2002		DISCN	Yes	No
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-003	Oct 10, 2002		DISCN	Yes	No

Expired US Patents for AVANDAMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-002	Oct 10, 2002	6,166,042*PED
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-002	Oct 10, 2002	5,741,803*PED
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-005	Aug 25, 2003	7,358,366*PED
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-002	Oct 10, 2002	7,358,366*PED
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-001	Oct 10, 2002	8,236,345

International Patents for AVANDAMET

When does loss-of-exclusivity occur for AVANDAMET?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AVANDAMET around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	100744361
Turkey	200103060
China	1145783
Australia	674880
South Korea	20080081099

Supplementary Protection Certificates for AVANDAMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	300677	Netherlands		PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
0861666	SPC/GB07/009	United Kingdom		SPC/GB07/009: 20070126
1412357	77 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
0306228	38/2000	Austria		PRODUCT NAME: ROSIGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
1261586	2012C/016	Belgium		PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128

Market Dynamics and Financial Trajectory for AVANDAMET

Last updated: July 29, 2025

Introduction

AVANDAMET, a combination pharmacotherapy comprising rosiglitazone and metformin, has historically served as a mainstream treatment for type 2 diabetes mellitus (T2DM). Its clinical profile—targeting insulin resistance and glycemic control—has positioned it as a prominent player in the antidiabetic market. However, recent regulatory, competitive, and scientific developments are reshaping its market landscape. This analysis evaluates the evolving market dynamics, financial trajectory, and strategic implications surrounding AVANDAMET, providing stakeholders with comprehensive insights into its current and future positioning.

Market Overview

Product Profile and Therapeutic Context

AVANDAMET synergistically combines rosiglitazone, a thiazolidinedione enhancing insulin sensitivity, with metformin, a first-line oral hypoglycemic. Launched in the early 2000s, AVANDAMET gained widespread adoption owing to its efficacy in controlling hyperglycemia, especially in patients inadequately managed on monotherapy.

Regulatory Environment and Safety Concerns

However, the drug's journey has been marred by safety concerns—most notably cardiovascular risks associated with rosiglitazone, leading to regulatory restrictions worldwide. The U.S. Food and Drug Administration (FDA) revoked rosiglitazone’s widespread use in 2013, citing increased myocardial infarction risk, although some restrictions remain in certain markets, and its use persists under careful monitoring in others. These safety signals led to reduced prescriber confidence and a decline in market share.

Market Size and Revenue Trends

The global diabetes therapeutics market was valued at approximately USD 60 billion in 2022, with oral hypoglycemics comprising a significant segment. Despite declining prescriptions for AVANDAMET, combination therapies remain integral for complex T2DM management, especially in patients with insulin resistance. However, the market share of AVANDAMET has declined substantially due to competition from newer agents with better safety profiles.

Market Dynamics

Competitive Landscape

The antidiabetic landscape has become increasingly crowded, with several novel agents entering the market:

• SGLT2 inhibitors (e.g., empagliflozin, canagliflozin): Offer weight loss benefits and proven cardiovascular protection.
• GLP-1 receptor agonists (e.g., semaglutide, dulaglutide): Demonstrate significant glycemic control alongside cardiovascular and renal benefits.
• DPP-4 inhibitors (e.g., sitagliptin): Provide safety advantages and ease of use with a favorable side-effect profile.

AVANDAMET's position has been further challenged by these newer agents, which often outperform it in safety and efficacy metrics.

Regulatory and Safety-Driven Market Withdrawals

Regulatory actions, notably the FDA’s restrictions on rosiglitazone, heavily impacted AVANDAMET’s sales. Many regions have either withdrawn approval or limited its use. Consequently, pharmaceutical companies have scaled back marketing efforts or diversified portfolios to align with safer alternatives.

Pricing and Reimbursement Dynamics

Safety concerns and market shifts have led to price erosion for AVANDAMET. Reimbursement policies favor newer agents, often offering higher margins and better coverage, further disincentivizing prescriber loyalty.

Patent and Intellectual Property Considerations

While AVANDAMET’s core components have faced patent expirations, generic formulations have increased price competition. This commoditization reduces profitability, especially under strict regulatory environments.

Financial Trajectory

Historical Revenue Performance

Historically, AVANDAMET generated peak revenues in the late 2000s, reaching several hundred million USD globally. Its sales significantly declined post-2013, coinciding with regulatory restrictions and the emergence of alternative therapies.

Current and Projected Revenues

In recent years, AVANDAMET’s revenues have plateaued or declined, with some estimates reflecting a 70-80% drop since its peak. Future revenues are projected to remain subdued unless new indications, formulations, or formulation innovations are developed.

Cost of Compliance and Litigation

Ongoing safety liabilities and lawsuits, particularly related to rosiglitazone’s cardiovascular risks, entail substantial legal costs. These liabilities impact the overall profitability and financial stability of associated pharmaceutical entities.

Market Exit and Portfolio Repositioning

Many pharmaceutical firms have phased out AVANDAMET or shifted R&D focus toward novel agents with superior safety profiles. Some companies are investing in developing improved formulations or combination therapies with better side effect management to revive the product’s market position.

Strategic Considerations

Reformulation and Line Extensions

Development of new formulations (e.g., lower-dose versions, fixed-dose combinations with newer agents) could potentially reintroduce AVANDAMET into certain markets—particularly where regulations permit the continued use of rosiglitazone under stringent safety monitoring.

Regulatory Re-approvals and Labeling

Efforts to secure revised regulatory approvals necessitate comprehensive safety data, with some companies exploring pharmacovigilance and risk management strategies to facilitate market re-entry.

Partnering and Licensing Opportunities

Collaborations with biotech entities or licensing agreements for safer analogs could provide avenues for revitalization, contingent upon demonstrated safety and efficacy.

Market Diversification

Expanding into niche markets—such as specialized populations where alternative therapies are less suitable—may offer limited but strategic growth opportunities.

Conclusion

The market dynamics surrounding AVANDAMET reflect a complex interplay of safety concerns, competitive innovation, and regulatory shifts. Its financial trajectory exhibits a marked decline from peak revenues, compounded by the advent of novel, safer antidiabetic therapies. While opportunities remain for niche re-formulation or licensing strategies, the overall outlook necessitates cautious optimism. Companies must navigate stringent safety regulations, market preferences, and patent landscapes to carve strategic pathways for their portfolios.

Key Takeaways

• AVANDAMET’s dominant period ended with safety revelations about rosiglitazone, leading to increased regulatory scrutiny and declining sales.
• The rise of SGLT2 inhibitors and GLP-1 receptor agonists has overshadowed AVANDAMET, challenging its relevance.
• Future growth hinges on innovative formulations, strategic licensing, or niche market targeting amidst ongoing safety concerns.
• Market exit or repositioning appears inevitable for many players unless significant safety improvements or new indications are developed.
• Stakeholders should prioritize safety profiling, regulatory engagement, and diversification to sustain value from legacy products like AVANDAMET.

FAQs

1. Why did AVANDAMET’s market share decline significantly?
Safety concerns related to rosiglitazone’s cardiovascular risks, regulatory restrictions, and the availability of superior newer therapies contributed to its decline.

2. Are there ongoing efforts to reformulate AVANDAMET?
Some pharmaceutical companies explore reformulations and combining newer agents with metformin to enhance safety and efficacy, but these are not widespread.

3. What are the primary competitors to AVANDAMET in the T2DM market?
SGLT2 inhibitors and GLP-1 receptor agonists are primary competitors due to their proven cardiovascular benefits and favorable safety profiles.

4. Can AVANDAMET still be prescribed in any markets?
Yes, in some regions, its use persists under strict regulatory guidelines, primarily where alternative therapies are limited or contraindicated.

5. What is the future outlook for legacy antidiabetic combination therapies like AVANDAMET?
The outlook is cautious; unless safety profiles improve or new therapeutic indications emerge, these combinations are likely to diminish in market relevance.

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Sources:

1. FDA Drug Safety Communication, 2013
2. International Diabetes Federation. Global Diabetes Statistics 2022.
3. GlobalData Healthcare. "Antidiabetic Drugs Market Report," 2022.
4. EMA Guidelines on Thiazolidinediones and Cardiovascular Safety, 2012.
5. Market Research Future. "Diabetes Therapeutics Market Analysis," 2023.