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Rosiglitazone maleate - Generic Drug Details

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What are the generic drug sources for rosiglitazone maleate and what is the scope of patent protection?

Rosiglitazone maleate is the generic ingredient in two branded drugs marketed by Sb Pharmco and Ani Pharms Inc, and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Rosiglitazone maleate has forty-five patent family members in thirty-six countries.

There are twelve drug master file entries for rosiglitazone maleate. One supplier is listed for this compound. There are six tentative approvals for this compound.

Summary for rosiglitazone maleate

International Patents:	45
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	12
Suppliers / Packagers:	1
Bulk Api Vendors:	58
Clinical Trials:	15
Patent Applications:	4,644
Formulation / Manufacturing:	see details
DailyMed Link:	rosiglitazone maleate at DailyMed

Recent Clinical Trials for rosiglitazone maleate

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

Sponsor	Phase
Mutual Pharmaceutical Company, Inc.	Phase 1
Cetero Research, San Antonio	Phase 1
GlaxoSmithKline	Phase 1

See all rosiglitazone maleate clinical trials

Generic filers with tentative approvals for ROSIGLITAZONE MALEATE

Applicant	Application No.	Strength	Dosage Form
		8MG	TABLET; ORAL
		4MG	TABLET; ORAL
		2MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for rosiglitazone maleate

Drug Class	Peroxisome Proliferator Receptor gamma Agonist Thiazolidinedione
Mechanism of Action	Peroxisome Proliferator-activated Receptor Activity

Paragraph IV (Patent) Challenges for ROSIGLITAZONE MALEATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
AVANDIA	TABLET;ORAL	rosiglitazone maleate	021071

US Patents and Regulatory Information for rosiglitazone maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms Inc	ROSIGLITAZONE MALEATE	rosiglitazone maleate	TABLET;ORAL	076747-003	Jan 25, 2013		DISCN	No	No
Sb Pharmco	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-003	May 25, 1999		RX	Yes	No					Y
Ani Pharms Inc	ROSIGLITAZONE MALEATE	rosiglitazone maleate	TABLET;ORAL	076747-002	Jan 25, 2013		DISCN	No	No
Ani Pharms Inc	ROSIGLITAZONE MALEATE	rosiglitazone maleate	TABLET;ORAL	076747-001	Jan 25, 2013		DISCN	No	No
Sb Pharmco	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-002	May 25, 1999		RX	Yes	No					Y
Sb Pharmco	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-004	May 25, 1999		DISCN	Yes	No					Y

Expired US Patents for rosiglitazone maleate

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

International Patents for rosiglitazone maleate

Country	Patent Number	Estimated Expiration
Algeria	3164
Canada	2370262
Australia	771342
European Patent Office	1277753
Brazil	0009935
Argentina	023560

Supplementary Protection Certificates for rosiglitazone maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0306228	2001C/004	Belgium		PRODUCT NAME: ROSIGLITAZONE; REGISTRATION NO/DATE: EU/1/00/137/001 20000717
0658161	C300035	Netherlands		PRODUCT: ROSIGLITAZONE,MALEAAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT.
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
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	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	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