AVANDAMET Drug Patent Profile

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

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVANDAMET

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

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
Austria	186724
Australia	2173888
Australia	611938
Brazil	1100841
Canada	1328452	COMPOSES (COMPOUNDS)
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 AVANDAMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	C300677	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
1412357	DO 77; 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
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
1412357	PA2008013,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
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	C300035	Netherlands		PRODUCT: ROSIGLITAZONE,MALEAAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT.

Investment Scenario and Fundamentals Analysis for AVANDAMET

Last updated: February 23, 2026

What is AVANDAMET?

AVANDAMET is a combination drug that contains rosiglitazone and metformin. Manufactured by GlaxoSmithKline (GSK), it is prescribed for managing type 2 diabetes mellitus. The medication enhances insulin sensitivity and reduces blood glucose levels, targeting a global market for diabetes management.

Market Overview

Global Diabetes Market

The global market for diabetes treatments, valued at $69 billion in 2021, anticipates compound annual growth rate (CAGR) of 6% through 2028, driven by rising prevalence, aging populations, and improved diagnostic rates [1].

Key Competitive Landscape

• Glucophage (metformin): Market leader for initial treatment.
• Actos (pioglitazone): Competes in the thiazolidinedione class.
• Innovative drugs: SGLT2 inhibitors (e.g., Jardiance, Invokana) and GLP-1 receptor agonists (e.g., Trulicity, Ozempic).

AVANDAMET occupies a niche in combination therapy but faces stiff competition from newer agents with improved safety profiles.

Pharmacological and Patent Fundamentals

Patent Status

• Original patents for rosiglitazone expired globally between 2013 and 2015; GSK’s combination patent for AVANDAMET expired or was invalidated in key territories by 2016.
• Generic versions are available in multiple markets, exerting downward pressure on prices.

R&D Investment and Pipeline

• Limited R&D specific to AVANDAMET; focus shifted toward newer therapies.
• No recent patent filings or exclusivity extensions reported for AVANDAMET.

Regulatory Landscape

• Approved in numerous countries, with some restrictions:
  • Concerns over cardiovascular risks related to rosiglitazone led to restrictions in the U.S. and Europe before the expiration of patents.
  • GSK removed rosiglitazone from some formulations in certain markets to address safety concerns.
• Ongoing monitoring and post-marketing surveillance vital due to safety profile.

Revenue and Sales Dynamics

Historical Sales Data

• Peak sales reached approximately £1.2 billion (~$1.6 billion) in 2009.
• By 2017, global sales declined to under £100 million (~$130 million), influenced by safety concerns and generic competition.

Regional Performance

• Europe and U.S. markets experienced substantial declines post-2010s.
• Emerging markets maintain limited uptake owing to generic availability and safety issues.

Pricing Trends

• Steady decline in per-unit price due to market saturation and generic competition.
• Margins compressing further as generic versions gain market share.

Investment Considerations

Positives

• Existing global infrastructure for distribution.
• Continued demand in markets with limited access to newer therapies.
• Potential niche for combination drugs in specific patient segments resistant to newer agents.

Negatives

• Patent expirations diminish exclusivity rights.
• Safety concerns impact prescribing patterns.
• Growing preference for agents with superior safety profiles and convenience.

Strategic Outlook

• Investment risk increases as patent cliffs deepen and generics dominate.
• Potential for reformulation or new combination therapies by GSK is limited.
• Market growth driven largely by unmet needs in emerging markets rather than the product itself.

Financial and Competitive Outlook

Factor	Impact	Notes
Patent Expiry	Negative	Leads to generic competition and price erosion.
Safety Profile	Negative	Influences physician prescribing behavior; regulatory restrictions apply.
Market Penetration	Limited in mature markets	Focus shifts to emerging markets with weaker regulatory environments.
R&D Investment	Minimal	No significant pipeline to sustain or boost product lifecycle.
Alternative Therapies	Increasingly preferable	Safety and convenience favor newer SGLT2 inhibitors and GLP-1 receptor agonists.

Key Takeaways

• AVANDAMET’s revenue declined sharply following patent expirations and safety concerns.
• Generic competition erodes margins; limited R&D diminishes future growth prospects.
• Positioned in a highly competitive and evolving diabetes pharmacotherapy landscape.
• Market demand persists in regions with unmet treatment needs but is offset by safety issues and newer drug alternatives.
• Investment risk correlates strongly with patent expiry and safety profile shifts.

FAQs

1. What factors have contributed to AVANDAMET's declining sales?
   Patent expirations, safety concerns regarding rosiglitazone, generic competition, and shifting prescriber preferences toward newer therapies.

2. Are there regulatory restrictions affecting AVANDAMET?
   Yes. Safety warnings and prescribing restrictions related to cardiovascular risks associated with rosiglitazone in some regions.

3. Is there potential for AVANDAMET in emerging markets?
   Limited potential exists due to affordability and availability of generics; however, demand persists where access to newer agents is restricted.

4. Could GSK reformulate AVANDAMET to extend its market life?
   No public indications suggest reformulation; safety concerns and patent expiry diminish incentives.

5. What is the outlook for future revenue from AVANDAMET?
   Prospects are bleak; continued decline due to patent expirations, generic competition, and safety issues dominate market dynamics.

References

[1] IDF Diabetes Atlas. International Diabetes Federation. 2022.