AVANDIA Drug Patent Profile

When do Avandia patents expire, 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
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	62
Patent Applications:	4,010
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AVANDIA
What excipients (inactive ingredients) are in AVANDIA?	AVANDIA excipients list
DailyMed Link:	AVANDIA at DailyMed

See drug prices for AVANDIA

Recent Clinical Trials for AVANDIA

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

Sponsor	Phase
Dan Zandberg	Phase 2
University Health Network, Toronto	N/A
Barcelona Institute for Global Health	N/A

See all AVANDIA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for AVANDIA

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 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

Expired US Patents for AVANDIA

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

International Patents for AVANDIA

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

Country	Patent Number	Title	Estimated Expiration
Australia	674880
Hungary	9500659
South Africa	9306509
Japan	H09183771	PRODUCTION DERIVATIVES OF SUBSTITUTED THIAZOLIZINEDIONE AND PHARMACEUTICALS CONTAINING THE SAME
Japan	2614497
Norway	320587
Argentina	023560	UNA FORMA POLIMORFICA DE ACIDO MALEICO DE UN DERIVADO DE TIAZOLIDIN-2,4-DIONA, COMPOSICION FARMACEUTICA Y EL USO DE LOS MISMOS PARA LA PREPARACION DE UNMEDICAMENTO

Supplementary Protection Certificates for AVANDIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0658161	SPC001/2001	Ireland		SPC001/2001: 20050808, EXPIRES: 20140928
0658161	C300035	Netherlands		PRODUCT: ROSIGLITAZONE,MALEAAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT.
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
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
0658161	CA 2001 00001	Denmark
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