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

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

International Patents for AVANDIA

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

Country	Patent Number	Title	Estimated Expiration
Austria	186724
Australia	2173888
Australia	611938
Brazil	1100841
Canada	1328452	COMPOSES (COMPOUNDS)

Supplementary Protection Certificates for AVANDIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0658161	SPC001/2001	Ireland		SPC001/2001: 20050808, EXPIRES: 20140928
0306228	2001C/004	Belgium		PRODUCT NAME: ROSIGLITAZONE; REGISTRATION NO/DATE: EU/1/00/137/001 20000717
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
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	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

AVANDIA (Rosiglitazone): Investment Scenario and Fundamentals Analysis

Last updated: February 3, 2026

Summary
AVANDIA, marketed by GlaxoSmithKline (GSK), is a thiazolidinedione used for type 2 diabetes management. The drug faced significant market loss and regulatory restrictions due to safety concerns, notably cardiovascular risks. Nonetheless, ongoing clinical research and potential label modifications could influence its future valuation.

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Market Overview and Historical Performance

Key Data	Details
Original Approval Date	1999 (FDA)
Peak Annual Sales (pre-2010)	Approximately $2.5 billion (globally)
Regulatory Restrictions (2010)	FDA bans in many markets, including restrictions on new prescriptions; existing uses limited.
Post-Restrictions Revenue	Declined sharply post-2010, with GSK shifting focus to other therapies.

Market Dynamics
AVANDIA was once a leading treatment for type 2 diabetes, accounting for a significant percentage of GSK's revenue. Market share shrank following studies linking rosiglitazone to increased myocardial infarction risk.[1] The FDA restricted its use in 2010, and similar measures occurred in Europe.

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Regulatory and Safety Landscape

Aspect	Details
FDA Actions	2010 ban on new prescriptions; continued availability for existing patients with risk disclosures.
European Medicine Agency (EMA)	Suspended marketing authorization in 2010; later permitted restricted use.
Safety Concerns	Cardiovascular adverse events (myocardial infarction, heart failure).

Regulatory Repercussions
In 2010, the FDA restricted AVANDIA's use following meta-analyses indicating increased cardiovascular risk. The EMA withdrew marketing authorization but later allowed limited use under strict conditions. Current global market access remains restricted, with some countries permitting certain patient populations.

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Current and Future Fundamental Drivers

1. Patent Status
   AVANDIA's primary patent expired around 2014, opening avenues for off-label sales, generics, or biosimilar development. GSK no longer markets the drug actively in many regions; generics are available in some markets.

2. Clinical Development and New Indications
   Research continues on rosiglitazone's potential in non-diabetic metabolic or inflammatory conditions. However, no significant new indications have received regulatory approval.

3. Comparative Drug Trends
   The rise of SGLT2 inhibitors and GLP-1 receptor agonists surpasses AVANDIA in efficacy and safety profiles.[2] These alternatives dominate the market, diminishing AVANDIA's commercial prospects.

4. Legal and Liability Risks
   Pending litigations in the U.S. relate to alleged cardiovascular damages. Pending lawsuits could affect legal liabilities and financial exposure.

5. Market Penetration and Pricing
   Limited market access and safety concerns constrain prices. GSK's strategic margins diminish further, especially with increased scrutiny on drugs with safety liabilities.

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Investment Risks and Opportunities

Risks	Details
Regulatory Decoherence	Ongoing restrictions in key markets.
Safety Litigation	Potential for significant legal liabilities.
Competitive Market Shift	SGLT2s, GLP-1s dominate treatment landscape.
Patent and Commercialization Issues	Expired patents enable generics, reducing margins.

Opportunities	Details
Repurposing or New Indications	Continued research might unlock new uses.
Limited-Licensing Agreements	Potential for licensing in niche markets.
Cost-Effective Generic Alternatives	Growing availability of generics can expand access in underserved regions.

Investment Outlook
The outlook for AVANDIA remains subdued in regulated markets. Its value hinges on potential label modifications or the discovery of new indications. Market trends favor newer drugs with better safety profiles. GSK's strategic divestment of the drug limits upside.

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Key Takeaways

• AVANDIA’s historical peak sales exceeded $2.5 billion but declined sharply after 2010 due to safety issues.
• Regulatory restrictions in major markets persisted, curtailing future revenue streams.
• The availability of superior treatment alternatives significantly limits its market relevance.
• Future value depends on clinical research outcomes and possible label modifications, although prospects are limited without regulatory approval.
• Legal liabilities and patent expiry dilute investment appeal; generic options further depress pricing.

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FAQs

1. What caused AVANDIA's decline in the market?
Safety concerns, particularly cardiovascular risks identified in meta-analyses, led to regulatory restrictions and diminished market share post-2010.

2. Could AVANDIA regain market approval?
Unlikely without new safety data or demonstration of improved benefit-risk profiles that satisfy regulators.

3. What are the primary competitors to AVANDIA?
SGLT2 inhibitors (e.g., Jardiance, Farxiga), GLP-1 receptor agonists (e.g., Trulicity, Ozempic) dominate the type 2 diabetes market currently.

4. Are there ongoing clinical trials for AVANDIA?
Research continues on rosiglitazone’s potential in other conditions, but no recent large-scale trials have led to regulatory approvals.

5. Is there potential for generic versions?
Yes, patent expiry opened the market for generics, but safety concerns limit prescribing and uptake.

Sources
[1] US Food and Drug Administration, Public Health Advisory, 2010.
[2] International Diabetes Federation, Global Market Analysis, 2022.